MONDAY ABSTRACTS. AB396 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
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1 MONDAY ABSTRACTS Mo1368 A Targeted Multicolor FISH Probe Set Increases the Diagnostic Sensitivity for Detecting Malignancy in Pancreatobiliary Brushings Emily G. Barr Fritcher* 1, Jesse S. Voss 1, Shannon Brankley 1, Michael B. Campion 1, Sarah M. Jenkins 1, Carin Y. Smith 1, Sarah E. Kerr 1, Ekaterina V. Pestova 2, Irina A. Sokolova 2, Minghao Song 2, Roongruedee Chaiteerakij 1, Lewis R. Roberts 1, Gregory J. Gores 1, Kevin C. Halling 1, Benjamin R. Kipp 1 1 Mayo Clinic, Rochester, MN; 2 Abbott Molecular, Inc., Des Plaines, IL Introduction: Differentiating benign from malignant pancreatobiliary (PB) strictures is often complex and hindered by imaging and sampling challenges. A definitive diagnosis requires integration of clinical, imaging, laboratory, and pathologic findings. Fluorescence in situ hybridization (FISH) using UroVysionÔ (Abbott Molecular, Des Plaines, IL), originally developed to identify bladder cancer, is currently used clinically by multiple institutions in conjunction with routine cytology for the detection of malignant cells in PB brushings. Recently, a FISH probe set (PB FISH assay) targeting 1q21, 7p12, 8q24, and 9p21 was developed specifically for the detection of PB carcinoma. The aims of this study were to assess the performance characteristics of the PB FISH assay and to compare these results to routine cytology and UroVysion FISH for the detection of malignancy in PB brushings. Methods: Routine cytology and UroVysion FISH were conducted on PB brushings per standard of care. Residual samples from 213 patients were retrospectively identified and hybridized with the PB FISH assay. Clinical characteristics (age, gender, primary sclerosing cholangitis [PSC], inflammatory bowel disease, jaundice), laboratory results (serum cancer antigen [CA] 19-9, total bilirubin), and imaging findings (presence of a mass) were abstracted from the electronic medical record. Polysomy (copy number gain of at least two loci) FISH was considered a positive test result for statistical analysis. The gold standard was clinicopathologic evidence of malignancy. Multivariable logistic regression was used to estimate the associations with PB malignancy. Results: Clinical sensitivity and specificity of cytology, UroVysion FISH and PB FISH are summarized in Table 1. Multivariate analysis demonstrated that cytology positive/suspicious (OR, 8.79), PSC status (OR, 0.10), CA 19-9R129 U/mL (OR, 3.37), mass detected by imaging (OR, 23.20) and PB FISH (OR, 19.16) were all significant predictors of malignancy. Lastly, the sensitivity of PB FISH (69.2%) outperformed both positive routine cytology (11.5%) and UroVysion FISH (42.3%) in the diagnostically challenging subgroup of PSC patients with a stricture and no identifiable mass. Conclusions: The newly designed PB FISH probe set increases the diagnostic sensitivity, without decreasing specificity, over routine cytology and UroVysion FISH for detection of PB tract malignancy. Further studies are warranted to determine if this new FISH probe set should be implemented as a routine clinical test in patients with a PB stricture. Clinical Sensitivity and Specificity of Cytology and FISH for Detecting Pancreatobiliary Tract Malignancy Patient Population Test Sensitivity % Specificity % Combined NZ213 CancerZ90 Primary Sclerosing Cholangitis (PSC) NZ131 CancerZ38 Non-PSC NZ82 CancerZ52 Positive Cytology Positive + Suspicious Cytology UroVysion FISH Pancreatobiliary FISH Positive Cytology Positive + Suspicious Cytology UroVysion FISH Pancreatobiliary FISH Positive Cytology Positive + Suspicious Cytology UroVysion FISH Pancreatobiliary FISH pancreatobiliary lesions is limited due to the low sensitivity of cytology. The utilization of fluorescence in situ hybridization (FISH) may aid diagnosis; however, studies to date have shown varying results. The aim of this study is to perform a systematic review and structured meta-analysis of all published studies to precisely estimate the overall sensitivity and specificity (diagnostic performance) of FISH in detection of pancreatobiliary malignancy. Methods: Searches of MEDLINE and Embase databases were performed through November A review of titles/abstracts, full review of potentially relevant studies, and data abstraction was performed independently by 2 authors. Studies were included if they allowed construction of 2 x 2 contingency tables of FISH compared with the final diagnosis. DerSimonian-Laird random-effect models were used to estimate the pooled sensitivity, specificity, specificity and quantitative receiver-operating characteristics. Results: Eighteen studies involving 2528 patients were included in our meta-analysis. The pooled sensitivity and specificity of FISH for diagnosis of pancreatobiliary malignancy were 72.8% (95% CI, 70.6%-75%) and 78.2% (95% CI, 75.4%-80.8%), respectively. The pooled positive predictive value (PPV), negative predictive value (NPV), and accuracy were 85% (95% CI, 83%-86.9%), 62.9% (95% CI, 60%-65.6%), and 74.8% (95% CI, 73.1%-76.5%), respectively. The pooled positive likelihood ratio (LR+), negative likelihood ratio (LR-), diagnostic odds ratio (DOR), and area under the curve (AUC) were 4.23 (95% CI, ), 0.36 (95% CI, ), 11.9 (95% CI, ), and , respectively. Subgroup analyses based on study size and publication year had no significant impact on diagnostic performance; however, FISH on EUS-FNA samples yielded a better sensitivity and significantly higher specificity and DOR, compared to FISH on ERCP-brush cytology specimens (Table 1). Conclusions: This is the first meta-analysis to summarize all the available evidence regarding the diagnostic performance of FISH in detection of pancreatobiliary malignancy. Our study suggests that FISH has moderately high sensitivity, specificity, and accuracy for diagnosis of pancreatobiliary malignancy. Compared to ERCP-brush cytology, FISH on EUS-FNA specimen has a very high specificity and DOR. Table 1. Subgroup analyses on diagnostic yield of FISH in diagnosing pancreatobiliary malignancy. No. of Studies N Sensitivity % (95% CI) Specificity % (95% CI) LR+ (95% CI) Year of Publication ( ) 82.5 ( ) 3.39 ( ) ( ) 74.2 ( ) 7.11 ( ) Sample size of study!200 patients ( ) 85.6 ( ) 7.49 ( ) O200 patients ( ) 72.4 ( ) 2.90 ( ) Type of cytology specimen ERCP-biliary duct brushing ( ) 75.9 ( ) 3.37 ( ) ERCP-pancreatic ( ) 86.7 ( ) duct brushing EUS-FNA ( ) 98.4 ( ) ( ) LR- (95% CI) 0.39 ( ) 0.34 ( ) 0.36 ( ) 0.35 ( ) 0.41 ( ) 0.28 ( ) DOR (95% CI) 8.9 ( ) 22.8 ( ) 19.2 ( ) 8.3 ( ) 8.9 ( ) 58.1 ( ) Mo1369 Fluorescence in Situ Hybridization (FISH) for Endoscopic Diagnosis of Pancreatobiliary Malignancy: a Systematic Review and Meta-Analysis Tarun Rustagi* 1, Thomas Mccarty 2 1 Section of Digestive Diseases, Yale University School of Medicine, New Haven, CT; 2 Department of Internal Medicine, Yale University School of Medicine, New Haven, CT Background: The diagnosis of pancreatobiliary malignancy is often based on cytological specimens collected during ERCP (via brushing) and/or EUS (via fine needle aspiration [FNA]). Although an accurate diagnosis is critical in the management of patients with suspected pancreatobiliary malignancy, the diagnosis of indeterminate Mo1370 Evaluation of Diagnostic Yield and Post-Procedure Pancreatitis of Brush Cytology via Duodenal Papilla for Pancreatic Tumorous Lesion Tesshin Ban* 1, Itaru Naitoh 3, Fumihiro Okumura 2, Issei Kojima 1, Hitoshi Sano 2, Takahiro Nakazawa 3, Etsuro Orito 1 1 Gastroenterology, Nagoya Daini Red Cross Hospital, Nagoya, Japan; 2 Gastroenterology, Gifu Prefectural Tajimi Hospital, Tajimi, Japan; 3 Gastroenterology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan Background: Pancreatic brush cytology (P-Cy) under endoscopic retrograde cholangiopancreatography (ERCP) is one of the procedures for acquiring the cytological evidence for a pancreatic tumorous lesion. However, there is concern about the AB396 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
2 diagnostic yield and post-procedure pancreatitis. We hypothesized that these outcomes were related to the distance from the papilla to the stenosis due to the pancreatic tumor. Objective: To evaluate the diagnostic yield and post-procedure pancreatitis of P-Cy focused on the distance from the papilla to the stenosis of the main pancreatic duct (MPD). Patients and Methods: We reviewed the medical records of the 88 patients who underwent P-Cy under ERCP from August 13, 2008 to September 2, Outcome Measure; (1) Rate of post-procedure pancreatitis. (2) Risk factor for post-procedure pancreatitis. (3) Diagnostic yield of P-Cy (accuracy, sensitivity, specificity, positive predictive value: PPV, negative predictive value: NPV). Results: (1) Overall rate of post-procedure pancreatitis was 9.5% (8/84). (2) In the analysis for the risk factor of post-procedure pancreatitis, it was detected that pancreatitis developed more frequently in patients with the distance from the papilla to the stenosis of the MPD at 40mm or more compared to those whose distance were under 40mm (25.0% (7/28), 1.8% (1/56), pz OR; 18.3 [95%CI; ]). The distance from the papilla to the stenosis was the independent risk factor for pancreatitis. (3) The background of the 88 cases was as follows; 65 cases were malignant (51 pancreatic cancers, 11 IPMCs, 1 gastric cancer invaded the pancreas, 1 cholangiocarcinoma, 1 metastatic carcinoma derived from kidney) and 14 cases were benign (5 AIPs, 6 chronic pancreatitises, 3 IPMNs). We obtained the final diagnosis from the surgical specimen, or through the clinical course, in the 79 cases. The diagnostic yield of P-Cy were as follows; sensitivity 40% (26/65), specificity 100% (14/14), PPV 100% (26/26), NPV 26.4% (14/53), accuracy 50.6% (40/79). Furthermore, the accuracy in the cases in which the distance from the papilla to the stenosis of the MPD was 40mm or more, decreased significantly compared to those that was under 40mm (32.0% (8/25) vs 57.7% (30/52), pz0.035). Conclusion: From the perspective of the poor diagnostic yield (accuracy; 32.0%) and the frequent postprocedure pancreatitis (25.0%), we should avoid the P-Cy under ERCP in case of pancreatic tumor at 40mm or more distance from the papilla. Mo1371 The Diagnostic Value of Brush Cytology Alone and in Combination With Tumor Markers in Pancreaticobiliary Strictures Ufuk B. Kuzu* 1, Bulent Odemis 1, Nesrin Turhan 2, Erkan Parlak 1, Selcuk Disibeyaz 1, Erkin Oztas 1, Nuretdin Suna 1, Adem Aksoy 1, Muhammet Y. Akpinar 1, Serkan Torun 1, Hakan Yildiz 1, Ertugrul Kayacetin 1 1 Gastroenterology, Turkish Highly Specialized Hospital, Ankara, Turkey; 2 pathology, Turkish Highly Specialized Hospital, Ankara, Turkey Aim: In patients with pancreaticobiliary strictures (PBD) the differentiation of benign and malignant strictures is crucial. However, the differentiation of malignant and benign strictures constitutes a problem despite the increasing experience of the endoscopists, radiologists and pathologists. The aim of our study is the determination of the factors that affect the efficacy of the ERCP assisted brush cytology in PBD and the evaluation of the its diagnostic successwhen used alone and together with tumor markers. Method: The data from brush cytologies of 301 PBD patients was collected retrospectively and analyzed. The final diagnosis was approved based on the histological examination of the tissue taken surgically or by other methods. In the absence of a histological diagnosis, the final diagnosis was based on radiological studies or the results of a 12 month clinical follow up. Patients with an indefinite diagnosis, with insufficient cytology results and with a tumor localized in the periampullar region were excluded from the study. The factors related to positive brush cytology results,determined during data analysis, were evaluated using multivariable logistic regression analysis. Results: Twenty eight patients, whose brush cytology results were insufficient were excluded from the study because they did not meet the gold standards. From the remaining 273 patients 299 samples were analyzed. The sensitivity and the specificity of brush cytology in diagnosing malignancy are 62.4% and 97.7, respectively. The sensitivity of brush cytology in identifying pancreas cancer and cholangiocarcinoma is 69.1% (38/55) and 69.5 % (41/59), respectively. Advanced age:1.2 ( ), sampling before dilatation:3.03 ( ), the size of a CT/USG detected mass being more than 10mm:1.7 ( ), CA-19.9 level:1.002 ( ), ALT:1.004 ( ) and total bilirubin level:1.11 ( ) were determined to be independent predictors for positive brush cytology. When analyzed using the ROC curve, among tumor markers only CA-19.9 and CA-125 were found to be significant in diagnosing malignancy (cut off value was 72.5 U/ml and 17.5 ng/ml, respectively), At this determined cut off values, the sensitivity and specificity of CA-19.9 and CA-125 were calculated to be 73.8 %, 79.5% and 74.4 %, 61.5%, respectively. The sensitivity of brush cytology increased to 94.1% when combined with CA-19.9 and CA-125. Conclusions: Brush cytology is a useful method in diagnosing pancreaticobiliary strictures. Its efficacy increases when used together with tumor markers such as CA-19.9 and CA-125. Advanced age, stricture dilatation before sampling, the presence of a mass identified by radiological studies, CA-19.9, high levels of ALT and total bilirubin increase the sensitivity of brush cytology. Mo1372 Classification of Indeterminate Pancreaticobiliary Strictures Pre- and Post-Biliary Stenting by Probe-Based Confocal LASER Endomicroscopy (pcle): a Comparison of the Miami vs. Paris Classifications Pushpak Taunk* 1, Satish K. Singh 1, David Lichtenstein 1, Ashish Sharma 2 1 Boston University Medical Center, Boston, MA; 2 Kaiser Permanente, Sacramento, CA Background: The diagnosis of indeterminate pancreaticobiliary strictures (IPS) is challenging due to the low sensitivity of ERCP. Prior studies have shown that pcle improves IPS classification accuracy using the Miami Criteria. However, after biliary stenting, stricture alteration may result in false positive readings of malignancy. Thus, the Paris Classification has incorporated specific pcle criteria for benign inflammatory strictures. Aim: Determine the accuracy of pcle for IPS, with and without a history of stenting, using the Miami and Paris Classifications. Methods: This study was conducted with IRB oversight at VA Boston. ERCP findings, pathology reports, abdominal imaging and pcle videos using the 1 mm CholangioFlexÔ probe (Mauna Kea Technologies) were reviewed in IPS cases with and without biliary stenting. Two investigators initially trained on 20 validated pcle videos with equal numbers of malignant and benign strictures. The investigators then reviewed 24 new videos and classified them based on the Miami criteria. Both investigators then trained on a second set of 30 validated pcle videos with an equal number of malignant, benign, and benign-inflammatory strictures. After viewing the second training set, the investigators were asked to re-classify the initial 24 videos based on the Paris Classification. Investigators were blinded to all clinical information. Results: 24 pcle videos were analyzed from 16 patients. In cases without stenting, using the Miami Criteria, the readers predicted pathology with an overall sensitivity of 88%, specificity of 75%, PPV of 64%, NPV of 92% and accuracy of 79%. After training on the Paris classification, the readers predicted pathology with a sensitivity of 63%, specificity of 88%, PPV of 71%, NPV of 82% and accuracy of 79%. In cases without stenting, using the Miami Criteria, the two readers predicted pathology with a sensitivity of 88%, specificity of 36%, PPV of 23%, NPV of 93% and accuracy of 45%. After training with the Paris classification, the readers predicted pathology with a sensitivity of 63%, specificity of 73%, PPV of 31%, NPV of 91% and accuracy of 71%. The overall kappa was 0.56, revealing moderate agreement. Based on the Miami Criteria, the two raters together incorrectly classified 80% of benign previouslystented strictures as malignant. After training on the Paris Classification, the rate of misclassification dropped to 38%. Conclusion: Our study shows that the specificity and accuracy of classifying IPS using the Miami criteria is reduced in prior biliary stenting. Use of the Paris Classification improved the specificity and accuracy of IPS classification in previously stented patients, though there was a decrement in sensitivity. Our findings highlight that use of the Paris criteria decreases the rate of over diagnosis of malignancy in the setting of prior biliary stenting. Mo1373 Molecular Analysis Increases the Diagnostic Yield and Sensitivity for Malignancy in Biliary Strictures Domenico Viterbo* 1, Frank Gress 1, Lauren G. Khanna 1, Ashish R. Shah 1, Amrita Sethi 1, John M. Poneros 1, Sara A. Jackson 2, Megan Blauvelt 2, Sydney D. Finkelstein 2, Tamas A. Gonda 1 1 Gastroenterology, Columbia Presbyterian Hospital, New York, NY; 2 Red Path Integrated Pathology, Pittsburgh, PA Introduction: Pancreaticobiliary malignancy is a lethal disease with a 5 year survival that is less than 5%. The vast majority of cases present with locally advanced disease. A large percentage of indeterminate biliary strictures are malignant. Biliary brush cytology is the standard method of sampling a stricture but has a low sensitivity for the detection of malignancy. In an effort to improve diagnostic yield, we investigated the utility of mutational DNA profiling from biliary specimens (supernatant, cytology, FNA) in conjunction with first line testing to identify patients with biliary strictures. Methods: Two cytology brushings were taken from patients with biliary strictures. The first and second brushes were placed into separate ThinPrep Cytolyte solutions and processed in a standard fashion for cytology and FISH analysis, respectively. FISH was performed using CEP 3, CEP 7, CEP 17, and 9p21 (p16)/cep 9 probes. For both brushings, DNA was extracted from the supernatant fluid that is otherwise discarded after cytocentrifugation performed when prepping cells for cytology or FISH. The extracted DNA was quantified by optical density and qualified by qpcr prior to mutational analysis. Mutational profiling of DNA from supernatants was performed using DNA markers, including those for KRAS point mutation and loss of heterozygosity (LOH) at 1p, 3p, 5q, 9p, 10q, 17p, 17q, 18q, 21q and 22q. Clinical or surgical outcomes were determined for each patient. Results: 93 patients underwent ERCP to evaluate biliary strictures. 41% of cases were malignant and 69% of these were distal biliary strictures. 17% of patients with a malignant diagnosis had a positive cytology. In all cases where cytology was negative or accellular (83%), second-line molecular testing (FISH and mutational profiling) yielded an assessable diagnosis. The performance characteristics of the individual diagnostic modalities and the combination of these modalities are reported in the Table. Cytology combined with either FISH or mutational analysis significantly improved sensitivity without a decrease in specificity. The combination of all three modalities yielded an Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB397
3 overall accuracy of 88% with a sensitivity of 81%. Conclusion: Molecular testing is a valuable test in the diagnostic evaluation of indeterminate strictures. DNA mutational profiling increases the diagnostic yield of malignant biliary strictures when combined with brush cytology. Our data suggests that both FISH and mutational analysis can be used as second line diagnostic modality. Future studies will need to focus on evaluating the order in which these adjunct tests need to be performed. Combined diagnostic performance of first- and/or second-line testing Diagnostic Test % Accuracy % Sensitivity % Specificity % PPV % NPV 1st Line testing Cytology Combinations Cytology st & 2nd Line testing FISH Cytology Molecular Cytology + FISH + Molecular hours, the rate of all contrast drainage was a higher tendency in flower group than conventional group without significant difference (71.4% vs. 28.6% pz0.28). Conventional group had a higher CRP levels and histologic total scores of gallbladder inflammation than flower group (CRP level on day 2; 35.23μg/dL vs μg/dL p- value Z0.03 and total score, median 4 vs. 2 pz0.03). Conclusions: The new flowertype CSEMS is technically feasible and may prevent a cholecystitis without disturbance of bile flow on swine model. Mo1374 The Effects of a Biliary Stent Registry on Complications Related to Biliary Stenting Marie Ooi*, Ken Liu, Santosh Sanagapalli, James L. Cowlishaw, Gavin Barr, Rupert W. Leong, Peter Katelaris Gastroenterology, Concord Hospital, Sydney, NSW, Australia Background: Inadvertent delay in stent removal or exchange may increase the risk of biliary sepsis from stent occlusion. A biliary stent registry is a prospective record of biliary stents inserted for the purpose of recalling patients due for stent exchange or removal. There is little published data on the impact of a biliary stent registry on complications related to stent placement. Aims: To compare the rate of stent related sepsis before and after the introduction of a biliary stent registry. Methods: We performed a 4 year retrospective analysis ( ) and after introduction of a stent registry, a 1 yr prospective analysis (2014) of patients presenting with biliary stent related sepsis. Demographics, co-morbidities, indications for stenting, stent type and patient outcomes were reviewed. A propensity score-matched analysis and regression adjustment was performed to identify factors associated with sepsis related to biliary stents. Results: In 885 ERCPs performed (57% female, a median age of 72 yr, interquartile range yr), 313 underwent biliary stenting. Malignancies (nz154) included pancreatic cancer 90%, cholangiocarcinoma 5%, metastatic gallbladder cancer 3% and liver metastasis 2%. Benign biliary disease (nz159), were related to choledocholithiasis 86%, bile leaks 12%, autoimmune pancreatitis 1% and idiopathic biliary stricture 1%. Stent occlusion occurred in 58/269 (22%) before and 4/44 (9%) (p!0.001) after the use of the registry. Stent related sepsis occurred in 34/ 269 (13%) before and 2/44 (5%) after (pz0.004). In patients with malignant biliary disease, the mean duration of plastic stents in situ pre- vs post-registry was 3.8 mths vs 1.5 mths (pz0.34) and 6.8 mths vs 6.7 mths for metal stents (pz0.78). For benign diseases, the mean duration of plastic stents in situ 8.9 mths vs 3.2 mths prevs post-registry (pz0.02). There were no stent occlusion occurred with covered metal stents. Analysis with matching by propensity score showed a reduction in stent related sepsis after the introduction of a stent registry (OR 0.363; 95% CI ; p Z0.02). After adjusting for indication for stent and stent type, the use of a stent registry was still associated with a lower risk of stent related sepsis (adjusted OR 0.581; 95% CI ; p!0.01). Conclusion: A stent registry reduces rates of stent related sepsis due to a reduction in stent occlusion facilitated by a timely stent replacement. All providers of ERCP should maintain a stent registry to minimise stent related complications due to inadvertent delay in stent exchange or removal. A. Pentagonal shape with five petals Mo1375 A Novel Flower Type Covered Metal Stents to Prevent Cholecystitis: Experimental Study in a Pig Model Young Sik Woo*, Jong Kyun Lee, Dong Hyo Noh, Sehun Oh, Kwang Hyuck Lee, Kyu Taek Lee Division of Gastroenterology, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea (the Republic of) Background and Aims: A flower-type covered self-expanding metal stents (FCSEMS), a five-petal shaped stent with side grooves, was designed to prevent the obstruction of the cystic duct orifice. The aim of study was to investigate whether FCSEMS could protect against the cholecystitis in a pig model. Methods: Fourteen pigs were randomly underwent endoscopic placement of either FCSEMS or conventional CSEMS. It was placed across the cystic duct orifice to impede bile drainage from gallbladder. The drainage of contrast was checked on 24, 48, 120 and 168 hours. The animals were sacrificed for histologic evaluation on day 7. Results: All stents were successfully inserted into bile duct without any procedure-related complications. At B. Five grooves at the sides parallel to the long axis AB398 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
4 Mo1376 Biliary Endoprosthesis: a Retrospective Analysis of Biliary Stent Related Late Complications Marie Ooi*, Santosh Sanagapalli, Ken Liu, Gavin Barr, James L. Cowlishaw, Rupert W. Leong, Peter Katelaris Gastroenterology, Concord Hospital, Sydney, NSW, Australia Biliary endoprosthesis: Biliary endoprosthesis: A retrospective analysis of biliary stent related late complications. Background: Biliary sepsis may occur following placement of biliary stents either due to stent dysfunction or delay in scheduled interval stent exchange. Causes of stent dysfunction include stent occlusion by debris or tumour ingrowth, stentmigration and stent fracture. Thechoice ofstent type dependson the life expectancy of the patient. According to the European Society of Gastroenterology guidelines, plastic stents are cost effective if estimated life expectancy is!4 months while self-expandable metallic stents (SEMS) are preferred if life expectancy exceeds 4 months. Aims: To assess the frequency and causes oflate (after30 days) complications of biliary stenting. Methods: We retrospectively analysed patients presenting with complications related to biliary stents over a 4-year period (Jan 2010-Dec 2013). Data collected included demographics, co-morbidities, indication for stent insertion and stent type(s). Primary outcome was stent related complications. Results: Of 699 patients who had ERCP (58% female, median age 73 yr ; interquartile age range yr), 269 had biliary stents inserted, 141 for malignant biliary strictures (Group 1) and 128 for benign biliary disease (Group 2). In Group 1, 118 (84%) had initial palliation of biliary obstruction with a plastic stent while 23 (16%) had a SEMS. In Group 2, a majority (nz118, 92%) had plastic stents and 10 (8%) had a SEMS. A total of 68 patients (25%) had stent related complications, of which 58 (22%) presented with obstructive jaundice or cholangitis due to occluded stents ( stents/ yr). Other complications included cholecystitis (nz3), liver abscess (nz1), stent migration (nz5), and stent fracture (nz1). In Group 1, plastic stents had an OR 4.3 (95% CI ; p!0.01) for stent occlusion compared to SEMS. In malignant biliary strictures, the time to stent occlusion for plastic, bare metal stents and covered metal stents were 2.1, 6.6 and 11.9 months, respectively. For Group 2, all 23 occluded stents occurred with plastic stents in patients lost to follow up with a mean stent patency of 24.9 months, whilst no stent occlusion occurred with covered SEMS. Conclusion: For malignant strictures, plastic stents had a significantly higher rate of occlusion and a lower duration of stent patency compared to SEMS. For benign biliary disease, all occluded stents were due to stents inadvertently left in situ for longer than recommended. A stent registry database is recommended to record all patients with biliary stents to ensure prophylactic stent exchange occurs at a timely interval to reduce the risk of biliary sepsis related to stent occlusion. For malignant strictures, earlier stent revision (! 2 months) should be considered if a plastic stent was inserted. Stent occlusion based on stent type in the 2 groups. Stent type Number of occluded stents Malignant Benign Total Plastic stent Bare metal stent Covered metal stent large diameter of 12mm can be a novel stent in patients with MBS for both preoperative and palliative management. Long-term follow up and prospective comparative studies with large number of patients were needed to evaluate the usefulness of intraductal placement of this stent. Mo1378 Is There a Survival and Morbidity Benefit of Covered Over Uncovered Metal Stents in Malignant Biliary Strictures? a Meta-Analysis and Systematic Review Harsha Moole* 1, Sonu Dhillon 2, Fritz-Henry Volmar 2, Michael D. Cashman 2, Matthew L. Bechtold 3, Srinivas R. Puli 2 1 Department of Internal Medicine, University of Illinois College of Medicine Peoria, Peoria, IL; 2 Department of Gastroenterology and Hepatology, University of Illinois College of Medicine Peoria, Peoria, IL; 3 Department of Gastroenterology and Hepatology, University of Missouri at Columbia, Columbia, MO Background: Palliation in unresectable malignant biliary strictures can sometimes be achieved by placing a self expandable metal stents (SEMS). It is not clear if covered metal stents have a morbidity and survival benefit compared to uncovered metal stents in these patients. There have been recent retrospective studies and randomized controlled trials that evaluated the clinical efficacy of covered and uncovered stents. This is a meta-analysis to pool the evidence for morbidity and survival benefit with covered versus uncovered stents in these patients. Aim: Compare survival benefit and morbidity in patients with malignant biliary strictures managed with covered metal stents versus uncovered metal stents. Method: Study Selection Criteria: Studies using covered and uncovered metallic stents for palliation in patients with malignant biliary stricture / obstruction. Data collection & extraction: Articles were searched in Medline, Pubmed, Ovid journals, CINAH, International pharmaceutical abstracts, old Medline, Medline nonindexed citations, and Cochrane Central Register of Controlled Trials & Database of Systematic Reviews. Two reviewers independently searched and extracted data. Any differences were resolved by mutual agreement. Statistical Method: Pooled proportions were calculated using both Mantel-Haenszel method (fixed effects model) and DerSimonian Laird method (random effects model). The heterogeneity among studies was tested using Cochran s Q test based upon inverse variance weights. Results: Initial search identified 1436 reference articles, of which 132 were selected and reviewed. 14 studies (NZ2239) for covered and uncovered metal stents which met the inclusion criteria were included in this analysis. Pooled fixed effects analysis of survival benefit in patients with covered versus uncovered stents showed the odds ratio to be 1.29 (95% CI Z 0.95 to 1.74). Odds for the overall adverse events (morbidity) in covered stent group compared to uncovered stent group was 1.12 (95% CI Z 0.86 to 1.47). The pooled effects estimated by fixed and random effect models were similar. The p for chi-squared heterogeneity for all the pooled accuracy estimates was O Conclusions: There was no statistically significant difference in survival benefit and morbidity of patients with distal biliary strictures managed with covered metal stents versus uncovered metal stents. Mo1377 A Newly Modified Non-Flared Fully Covered Metallic Stent of 12 mm-diameter With Long Lasso for Intraductal Placement in Patients With Malignant Biliary Stricture: Feasibility Study Jong Ho Moon*, Hyun Jong Choi, Yun Nah Lee, Hee Jae Jung, Moon Han Choi, Tae Hoon Lee, Sang-Woo Cha, Young Deok Cho, Sang-Heum Park Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea (the Republic of) Background and Aims: Suprapapillary intraductal placement of fully covered selfexpandable metallic stent (FCSEMS) for malignant biliary stricture (MBS) may prevent duodeno-biliary reflux and cholangitis. Non-flared, convex both ends of FCSEMS can minimize ductal injury by stent itself. Thus, intraductal placement of a non-flared FCSEMS can be a novel stent for MBS. The aim of this study was to evaluate the efficacy of newly modified, non-flared FCSEMS having 12mm in diameter with long lasso for intraductal placement in patients with MBS. Methods: 34 Patients with MBS and obstructive jaundice were enrolled in this study. The nonflared FCSEMS has 12mm in diameter with central portion of 8mm and long lasso of 7cm in distal end. Newly modified metallic stent was placed above the papilla. The main outcome was mean stent patency, and adverse effect. Perioperative complications were accessed in cases that undergone surgical resection of MBS. Results: Technical and clinical success rate was 100%. Early complications (%30 days) were occurred in 1 patient (post-procedure mild pancreatitis). Eight patients received surgery after stenting, and there were no peri- or postoperative complications. The mean stent patency was 277 days (range, ). Late complications (O30 days) were occurred in 26.9% (7/26) with stent migration in 2 patients, and stent occlusion in 5 patients. Conclusions: Intraductal placement of the non-flared FCSEMS with Mo1379 a Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction: Interim Analysis Moon Jae Chung*, Seungmin Bang, Seung Woo Park, SI Young Song Department of Internal Medicine, Institute of Gastroenterology, Yonsei University Health System, Seoul, Korea (the Republic of) Background and Study Aims: It has been found that the patency duration of covered metallic stent is longer than that of uncovered metallic stent in malignant biliary obstruction. But distal migration occurs more frequently in covered metallic compared to uncovered metallic stent. The aim of this study was to compare conventional uncovered metallic stent (S&G Biotech Inc. and Taewoong Medical) and uncovered double bare metallic stent (S&G Biotech Inc.) that was newly developed for the purpose of preventing tumor ingrowth and stent distal migration. Patients and Methods: Patients with inoperable malignant distal biliary strictures were included in the study and randomized to receive an uncovered metallic stent (S&G Biotech Inc.) (n Z 18), an uncovered metallic stent (Taewoong Medical) (n Z 17), or uncovered double bare metallic stent (S&G Biotech Inc.) (n Z 17) in Severance Hospital from June 2013 to June Stent occlusion was diagnosed if patients had recurrent jaundice with evidence of elevated bilirubin levels along with biliary dilation on CT, magnetic resonance imaging, or US. In case of stent dysfunction, a repeat ERCP was performed unless patients could not tolerate the procedure. Results: The median patient age was 68.5 years (range, 35-83) and 61.5% were male. The median follow-up period was days (range, ). There was no statistically significant difference in patency duration between uncovered metallic stent (S&G Biotech Inc.), uncovered metallic stent (Taewoong Medical) or uncovered double bare metallic stent (S&G Biotech Inc.) (100.5 days (18-347) vs days (20-346) vs. 142 days (3-393)). Three cases of post ERCP pancreatitis occurred in each group. Conclusion: Interim analysis showed that even though there was no Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB399
5 clinical difference statistically, newly developed uncovered double bare metallic stent have trend toward longer patency duration compared to conventional uncovered metallic stent. More sample size and follow-up period are required in order to verify these results. Mo1380 Early ERCP Placement of Short Self-Expanding Metal Biliary Stents (SSEMS) in Locally-Advanced Pancreatic Cancer With Biliary Obstruction Improves Success and Outcomes of Neoadjuvant Therapy Suraj Gupta 1, John Walker 1, Hani Jarawan 1, Lewis B. Richards 1, David Klibansky 1, Douglas A. Howell* 1, Justin Wilkes 2, Gina Z. Blaszyk 1, Lisa A. Rutstein 2 1 Pancreaticobiliary Center, Maine Medical Center, Portland, ME; 2 Surgery, Maine Medical Center, Portland, ME Background: Neoadjuvant therapy (NeoRx) has been increasingly reported for preoperative treatment of pancreatic adenocarcinoma (PANCA). In the subgroup of jaundiced patients (pts) treated with plastic biliary stents, occlusions during NeoRx have led to small series using short self-expanding metal stents (SSEMS) to facilitate NeoRx. We report a large single-center experience using non-foreshortening uncoated SSEMS. Methods: In our center, all pts with biopsy-proven PANCA causing obstructive jaundice regardless of stage undergo ERCP with SSEMS placement or prompt SSEMS replacement of plastic stents. Up-front surgery is recommended for early PANCA (Stage 1a) and palliative chemotherapy for late stages (III & IV). NeoRx of 8 wks of Gemcitabine with 2 wks of XRT is offered to stented pts with locallyadvanced or borderline resectable tumors. Pts are followed for evidence of stent dysfunction, impact on completion of NeoRx, progression of disease, and interference with surgery. All data points are entered into an IRB-approved database. Patients: 89 consecutive stented pts (age 36-87, median 68) accepted NeoRx. Stages were IBZ29, IIAZ38, IIBZ22. After 8 wks of NeoRx and a 4 wk rest, restaging was followed by surgery, if appropriate. Results: 88/89 underwent successful ERCP with 10x40 or 10x60 SSEMS placement without complication. One had post-eus hemobilia with transient SSEMS occlusion, which cleared before NeoRx began. During 8 wks of chemorx, 4/89 (4.5%) developed stent dysfunction (recurrent jaundice 3, cholangitis 1). Only 1 missed any chemorx (less than 5% of total doses). During the rest period 7/89 (7.9%) developed occlusion (jaundice 4, cholangitis 3) treated with ERCP. In addition, one case had stone-related cholecystitis and one had tumor bleeding requiring embolization. The role of the SSEMS was unclear in these two cases. 7/89 (7.9%) did not complete NeoRx (comorbidity 3, toxicity 2, dropout 2). At restaging, 22/82 (26.8%) revealed metastatic disease (nz19) and progression with vascular encasement (nz3). 60 cases underwent attempted Whipple resection and 12/60 (20%) proved to be unresectable due to mets or vascular encasement. Resections were successfully performed in 48/60 (80%) of restaged cases or 48/89 (53.9%) of the total study group. Resections were R0Z44, R1Z4, R2Z0. No interference with the line of resection or other surgical complications due to the presence of the SSEMS was recorded. Conclusion: In this large series, early ERCP placement of non-foreshortening uncoated SSEMS permitted NeoRx in all cases without interfering with treatment protocol or surgery. This approach allows pts with occult stage IV or biologically-aggressive cancers to avoid surgery. Reliable SSEMS placement below the line of resection, absence of migration, and avoidance of other early complications appear to be advantages of this approach. Mo1381 Survival Outcomes and Treatment Failure After Metal Biliary Stent and Open Surgical Biliary Bypass Among Patients With Advanced Pancreatic Adenocarcinoma Receiving Chemotherapy Alessandra Storino* 1, Rohan A. Maydeo 2, Ammara A. Watkins 1, Manuel Castillo-Angeles 1, William E. Gooding 3, Tara S. Kent 1, Mandeep Sawhney 2, A. James Moser 1 1 Institute of Hepatobiliary & Pancreatic Surgery, Beth Israel Deaconess Medical Center, Boston, MA; 2 Advanced Endoscopy and Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA; 3 Biostatistics Department, University of Pittsburgh Cancer Institute, Pittsburgh, PA Background: Recent modeling data indicate that rapid initiation of chemotherapy may improve survival among patients diagnosed with advanced pancreatic ductal adenocarcinoma (PDA). Biliary obstruction, and associated treatment-complications, may delay treatment and diminish survival. We hypothesized that self-expanding metal biliary stents (SEMS) permit earlier initiation of chemotherapy by comparison to open surgical biliary bypass (OSBB) with equivalent patency. Objective: Dual primary endpoints included overall survival and cumulative incidence of treatment failure for biliary obstruction. Methods: Retrospective analysis of 127 subjects with PDA and biliary obstruction diagnosed between subjects (OSBB) underwent surgical staging and OSBB for unresectable cancer or radiographicallyoccult metastases. 62 subjects received SEMS for locally-advanced disease or radiographically-occult metastases identified during surgical staging. Subjects with radiographically-detectable metastases were excluded. Results: The OSBB and SEMS cohorts did not differ with respect to age, gender, Charlson comorbidity Index, tumor size, or preoperative Ca19-9 (po0.05). Although NCCN classification demonstrated a higher initial proportion of resectable/borderline lesions in the OSBB (83%) vs. SEMS (45%) groups, the proportion of locally-advanced and occult metastatic PDA in the two cohorts was similar after surgical staging (pz0.37). Median time to initiation of chemotherapy was earlier in the SEMS (median 12 days, IQR 5-36) than OSBB group (47, IQR 32-63; (pz0.0033) but had no impact on median overall survival (11 months in both cohorts, pz0.81). Allocation to stent or surgery was not associated with overall survival (HR: 1.09, 95% CI: , pz.7604). Conversely, median time to treatment failure was 15 months in the SEMS cohort and 29 months after OSBB (pz0.018, Figure 1) and was significant after adjusting for the cumulative risk of death (pz0.0055). 24% of subjects required re-intervention after SEMS compared to 8% after OSBB (pz0.014). The median Comprehensive Complication Index was 0 (0-26.2) after SEMS and 8.7 (0-28.5) after OSBB and (pz0.1198), corresponding to longer median total hospital stay from intervention to death/loss to follow up after OSBB (median 8 days, IQR 7-11) compared to SEMS (median 1 day, IQR 0-5; p!.0001). Conclusion: SEMS was associated with faster initiation of chemotherapy and reduced total hospitalization but had no beneficial impact on survival compared to OSBB. OSBB demonstrated longer hospitalization but superior patency that may become clinically-relevant with improving chemotherapy. We conclude that enhanced postoperative recovery after minimally-invasive surgery warrants a prospective randomized clinical trial between SEMS and biliary bypass with the dual endpoints of survival and incidence of treatment failure. Figure 1. Cumulative Incidence of Treatment Failure Mo1382 Safety and Efficacy of New Covered Stent With Flared Portion (Flared-Comvi) in Patients With Malignant Gastric Outlet Obstruction Naminatsu Takahara*, Hiroyuki Isayama, Yousuke Nakai, Tsuyoshi Hamada, Dai Mohri, Hirofumi Kogure, Saburo Matsubara, Natsuyo Yamamoto, Minoru Tada, Kazuhiko Koike Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan Background & Aim: Endoscopic placement of self-expandable metal stents (SEMS) has emerged as a palliative treatment for malignant gastric outlet obstruction (GOO). Although several reports showed the safety and efficacy of covered and uncovered SEMSs for GOO, both of them have inherent advantages and disadvantages. Generally, covered SEMS can prevent tumor ingrowth which is main cause of occlusion of uncovered SEMS, but have a higher chance to migrate. Frequent migration of covered SEMS may offset its main advantage in preventing tumor ingrowth. Therefore, we developed a new covered SEMS with additional uncovered flare at oral end, Flared-ComVi, to prevent both tumor ingrowth and stent migration. Patients & Methods: Between March and November 2014, 19 patients with symptomatic malignant GOO were managed with Flared-ComVi stents. The primary endpoint was improvement of GOO scoring system (GOOSS) score. Secondary endpoints were technical and clinical success rate, patency, and complications. Results: The study participants consisted of 11 males (58%) with a median age of 68 years. The etiologies of GOO were pancreatic cancer in 7 (37%), gastric cancer in 7(37%), other in 5(26%).The median GOOSS score significantly improved after stenting from 0 to 3 (P! 0.01). Technical success was achieved in all cases, and clinical success rates were 92%. The median eating period and survival time were 3.1 and 4.6 months, AB400 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
6 respectively. Major complication was only stent occlusion, without perforation and bleeding were not observed. Re-intervention with an additional stent placement was required in 5 patients (26%), including tumor overgrowth in 3 and migration in 2. No stent occlusion by tumor ingrowth developed during a median follow-up period of 3 months. Stent migration occurred in which placed for recurrent gastric cancer at gastrojejunostomy anastomotic site. Conclusions: The Flared-ComVi stent placement for malignant GOO was technically feasible and effective in a short term. Although the Flared-ComVi stent can prevent tumor ingrowth, it may not suitable for anastomotic site obstruction. A large-scale prospective randomized study with a long-term follow up is warranted. Mo1383 Survival Time and Surgical Outcomes in Patients With Malignant Severe Obstructive Jaundice Pushpak Taunk*, Jason Korenblit, Ali Siddiqui, David E. Loren, Harish Lavu, Thomas E. Kowalski Thomas Jefferson University Hospital, Philadelphia, PA Background: Routine preoperative biliary drainage for surgically resectable pancreatic cancer remains controversial and is not recommended for many patients presenting with obstructive jaundice. It has been suggested that patients with severe jaundice may have greater surgical morbidity and mortality due to hepatic dysfunction secondary to biliary obstruction. Currently, there are no data to determine if the degree of biliary obstruction correlates with adverse outcomes. Aim: The aim of this study was to compare surgical outcomes and survival of patients with severe obstructive jaundice (SJ), defined as total bilirubin O10mg/dL to those without severe obstructive jaundice (WSJ), defined as total bilirubin!10mg/dl. Methods: We performed a case-controlled retrospective study of pancreatic cancer patients with obstructive jaundice who underwent resection. Pancreas cancer patients were stratified according to degree of pre-operative jaundice. Controls were matched 1:1 to cases based upon tumor stage. Data was compiled on patient demographics, pre-operative bilirubin levels, tumor stage at the time of surgery, intraoperative blood loss (EBL), need for blood transfusions, immediate post-operative complications, hospital length of stay (LOS) and overall patient survival. Results: 27 patients (mean agez66, 59% males) with SJ and 28 stage-matched controls (mean agez63, 54% males) WSJ were evaluated. There was no difference in tumor stage between the two groups. There was a significant decrement in the mean survival time for those with SJ, mean Z486 (medianz466, range ) days compared to 905 (medianz726, range ) days for those WSJ (pz0.0027). There was a significant decrement in mean survival time among deceased patients (22/27 SJ, 19/ 28 WSJ) for those with SJ, mean Z 408 days compared to 747 days for those WSJ (pz0.009). 4 patients with SJ required transfusions compared to 3 patients WSJ. There was no statistically significant difference in EBL between the two groups (485 ml vs. 605mL, p Z 0.32). The overall immediate post-operative complication rate in both groups was similar, 11/28 (39%) for SJ and 12/29 (41%) for WSJ. The mean length of stay was near identical in both groups at 8 days. One patient with SJ was discharged to a rehabilitation facility, compared to 3 patients WSJ. Adjuvant chemotherapy was administered to 22/27 patients in the SJ group compared to 16/28 in those WSJ. Conclusion: Pancreatic cancer patients with severe obstructive jaundice have a lower mean survival time than those without severe obstructive jaundice, without a significant difference in EBL, complication rates or hospital LOS. This result may suggest unforeseen effects of severe jaundice. Alternatively, the result may be a manifestation of the retrospective study design and relatively small sample size. A prospective study is now being conducted. Mo1384 Long Term Outcomes, Recurrence RATES and Complications of Endoscopic Ampullectomy for Ampullary Lesions Ashish R. Shah* 1, Mikram Jafri 2, Lauren G. Khanna 1, Amrita Sethi 1, Tamas A. Gonda 1, John M. Poneros 1, Frank G. Gress 1 1 Digestive & Liver Diseases, Columbia University, New York, NY; 2 Internal Medicine, St. Lukes Roosevelt Hospital, New York, NY Background: Ampullary adenomas have the potential to progress from benign to malignant lesions. Endoscopic ampullectomy is increasingly being used as a safe and effective alternative to surgical resection to remove ampullary adenomas. However studies showing long term follow-up and outcomes are limited. Aim: To determine rates of recurrence, long term outcomes and complications in patients who underwent endoscopic ampullectomy for ampullary lesions. Methods: The study is a retrospective chart review of patients who were found to have an ampullary lesion and underwent endoscopic ampullectomy from at a single academic tertiary referral center. Patients were identified by the use of an electronic endoscopic database. Charts were reviewed to determine indication for ampullectomy, pathology results, need for repeat procedure or surgery, complications, and long term follow-up in terms of recurrence of ampullary lesions and mortality. Results: A total of 52 patients (pts) with ampullary lesions were identified, 29 males and 25 females. Of the total patients identified, 15% (8/52 pts) had ampullary adenocarcinoma on initial endoscopy and 64% (33/52 pts) had adenomatous polyps with 3 having high grade dysplasia (HGD) and 5 with low grade dysplasia. A total of 19% (10/52 pts) had tubulovillous adenomas with 2 having HGD. One patient was found to have an ampullary ganglioma. Of the total patients identified, 54% (28/52 patients) underwent an endoscopic ampullectomy and 21% (13/52 pts) underwent surgery. The remaining 11 patients did not have either endoscopic resection or surgery, or were lost to follow-up. Mean follow-up was 34 months post endoscopic ampullectomy and 20 months post surgery. The majority of patients had ampullary lesions resected using hot snare polypectomy (24/28 pts) with 21% (6/28 pts) having argon photo coagulation of residual tissue afterwards. 82% (23/28 pts) had a pancreatic duct stent prior to endoscopic resection. 32% (9/28 pts) had residual adenomatous tissue during first follow up endoscopy with an average of 2.8 repeat endoscopies for full removal of the lesions. Only 14% (5/28 pts) had complications following endoscopic ampullectomy. Of the patients who developed complications, 4 out of 5 had post-procedural bleeding with only one patient requiring a repeat endoscopy for hemostasis. The fifth patient developed pancreatitis post-procedure. No other complications were seen. Only 2 patients required surgery after endoscopic ampullectomy. Only 3 patients had recurrence of adenomatous tissue after endoscopic ampullectomy and 2of them were treated with repeat endoscopic removal and did well. Conclusion: In patients with ampullary adenomatous tissue, endoscopic ampullectomy is safe and effective with minimal post-procedural risks and low risk of recurrence over a long term follow-up period. Mo1385 Is Preoperative Drainage Necessary in Patients With Periampullary Cancer? Young Taek Kim, Ho Soon Choi, Kang Won Lee*, Kang Nyeong Lee, Hang Lak Lee, Dae Won Jun, Kyo-Sang Yoo, Oh Young Lee, Byung Chul Yoon, Joon Soo Hahm Department of Internal medicine, Hanyang University School of Medicine, Seoul, Korea (the Republic of) Background and Aims: Preoperative biliary drainage was introduced to improve both symptoms of obstructive jaundice and outcomes after surgery in patients with periampullary cancer. However, recent reports suggest that preoperative biliary drainage actually increases peri-operative morbidity and mortality of pancreaticoduodenectomy. We conducted a study to evaluate the relationship between preoperative drainage and clinical outcomes (including hospital course, biochemical factors and post-operative complications). Patients and Methods: Eighty-eight periampullary cancer patients with jaundice (total bilirubin O2.0mg/dl) underwent pancreaticoduodenectomy at Hanyang University Hospital between 2000 and Seventy nine patients recieved pre-operative drainage(d group) and nine patients had no biliary drainage(non-d group). D group was subdivided into three subgroups based on drainage method: Endoscopic nasogastric biliary drainage group (ENBD group, nz33), Percutaneous transhepatic biliary drainage group(ptbd group, nz38) and others(nz8). We compared baseline characteristics, clinical course and post-operative complications between D group and non-d group and also between ENBD group and PTBD group. Results: In the comparison of non-d group and D group, total bilirubin at admission(5.34.2mg/dl vs mg/dl) and Hospital period( day vs ) was lower in non-d group and ALP( vs ), AST(9276 vs 5127), ALT( vs 5447) at operation was lower in D group. But there were no significant difference in baseline characteristics(age, gender, BMI, Charlson comorbidity index, Prognostic Nutritional Index, Neutrophil Lymphocyte index, Platelet Lymphocyte index, type of operation, histologic diagnosis), clinical course(wbc, hemoglobin, ALP, AST, ALT, total bilirubin, hospital course, intraoperative transfusion, Operation time) and postoperative complications(wound infection, abscess formation, hemorrhage, anastomosis site leakage, prolonged ileus and etcs.). The comparison between ENBD group with PTBD group showed no difference in baseline characteristics, clinical course and postoperative complications either. Conclusions: Our results suggest that neither pre-operative biliary drainage nor type of drainage method independently deteriorate clinical outcomes of periampullary cancer. Perioperative lab and operation related data Total (n [88) No drainage (n[9) Drainage (n [79) P- value ENBD (n [33) PTBD (n [38) P- value WBC(/mm3) Hb(mg/dl) Albumin(gm/dl) Admission ALP(IU/L) AST(IU/L) ALT(IU/L) TB(mg/dl) Pre-Op. ALP(IU/L) AST(IU/L) ALT(IU/L) TB(mg/dl) Post-Op. ALP(IU/L) AST(IU/L) ALT(IU/L) Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB401
7 Total (n [88) No drainage (n[9) Drainage (n [79) P- value ENBD (n [33) PTBD (n [38) P- value TB(mg/dl) Hospital period(day) Pre-op(day) Postop (day) Operation time(min) Intra-Operative Transfusion (pint) Post-operative complications Total (n [88) No Drainage vs Drainage No Drainage (n [9) Drainage (n[79) P- value ENBD(n [33) ENBD vs PTBD PTBD(n [38) P- value Wound infection(n) Intra-abdominal abscess(n) Infected fluid collection(n) Anastomosis leakage(n) Prolonged ileus(n) Hemorrhage(n) Complication total(n) Mo1386 Comparative Effectiveness of Metal Versus Plastic Stents for Preoperative Biliary Drainage in Resectable and Borderline Resectable Distal Malignant Biliary Obstruction: a Systematic Review and Meta-Analysis Tarun Rustagi* 1, Thomas Mccarty 2 1 Section of Digestive Diseases, Yale University School of Medicine, New Haven, CT; 2 Department of Internal Medicine, Yale University School of Medicine, New Haven, CT Background: Increasing numbers of patients with resectable and borderline resectable distal malignant biliary obstruction are receiving neoadjuvant therapy, and benefit from preoperative biliary drainage (PBD). While endoscopic PBD is the preferred approach, considerable controversy exists regarding the type of endobiliary stent (plastic vs. SEMS) which should be used. The aim of this study is to perform a systematic review and structured analysis of all eligible studies to evaluate the comparative effectiveness of plastic and metal stents in the treatment of resectable or borderline resectable distal malignant biliary obstruction. Methods: Searches of MEDLINE and Embase databases were performed through November Review of titles/abstracts, full review of potentially relevant studies, and data abstraction was performed independently by 2 authors. Measured outcomes including type of malignancy, length of hospital stay, time to surgical intervention, rate of re-ercp, complications, survival and follow-up were compared among plastic and metal stent studies. Results: Twenty-seven studies (24 retrospective [nz4403], 2 prospective [nz395], one randomized controlled trial [nz202]) were included in the analysis. Of these, a majority were resectable (nz2931); 193 were borderline resectable, and the remaining were eventually diagnosed with inoperable or benign disease. 18 of 27 studies had patients with pancreatic cancer (nz2490). 19 studies (nz3133) included patients with plastic stents, 2 studies (nz296) with metal stents, and 6 studies (nz1571) had patients with plastic and metal stents. No controlled study compared metal vs. plastic stenting. In total, plastic stents were placed in 2496 patients and 448 patients received metal stents. The overall complication rate was significantly higher in plastic stent group compared to the metal stent patients (57.8% vs. 30.6%; p!0.0001). Cholangitis/cholestasis (p!0.0001) and other infectious complications (pz0.0004) were more frequent in the plastic group. Pancreatitis, however, was more common in the metal stent group (pz0.0003). Patients with plastic stents were more likely to undergo repeat ERCP compared to those with metal stents (10% vs. 6.9%; pz0.44). Plastic stent group had a significantly longer hospitalization (14.1 vs. 7.8 days; p!0.001) and a higher mortality rate (2.3% vs. 0.22%; pz0.0014) compared to metal stent group. There was no significant difference between the time (delay) to surgery or rates of unresectability between the two stent groups. Conclusions: Metal stents are effective and safe and may offer improved outcomes in PBD of resectable or borderline resectable distal malignant biliary obstruction. Plastic stents are associated with a higher complication rate including recurrent episodes of stent occlusion resulting in unplanned ERCPs, longer hospitalization and increased mortality. Mo1387 Evaluation of Patients With Large Pancreatic Duct Stones Treated by Extracorporeal Shock Wave Lithotripsy and Endoscopic Retrograde Cholangiopancreatography Behzad Salari* 1, Natalia Hernandez 2, Yan Song 2, Brian H. Eisner 2, David G. Forcione 1 1 Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA; 2 Department of Urology, Massachusetts General Hospital, Boston, MA Background: Pancreatic duct (PD) stones are found in up to 60% of patients with chronic pancreatitis and management of large calculi remains a clinical challenge. There is no consensus on the role of shock wave lithotripsy (SWL) in the current treatment algorithm. In this study, we evaluated outcomes of patients treated at our institution with a combination of SWL and endoscopic therapy in the management of large PD stones. Methods: A retrospective review was performed of consecutive patients treated with SWL for pancreatic stones from Patients were referred to the urology clinic for SWL of pancreatic stones if endoscopic management (endoscopic retrograde cholangiopancreatography [ERCP]) was attempted and was unable to completely remove all stones. SWL procedures were performed using the Dornier Compact Delta electromagnetic lithotripter. The referring gastroenterologist determined number of treatment sessions. Results: We identified twenty-three patients (65% female, and 35% male) with the mean age of years (range, 38-82) at first SWL session. Overall, they underwent a total of 51 SWL sessions (2.2/patient), 89 ERCPs (3.9/patient), and 66 stent placements (2.9/patient). Six patients were also treated with electrohydrolic lithotripsy. Average lithotripsy settings were an intensity of 3, shock frequency of 100/minute, and total shocks of 2000/session. The average maximum primary stone size was mm (range, 6-35), with 74% located in head or neck of the pancreas. Acute pancreatitis due to SWL occurred in three patients (5.9%). No other significant complications were noted. Complete and partial clearance of the PD stones was achieved in 52% and 22%, respectively. Those with complete clearance underwent 2.5 SWL sessions on average. The majority of patients with complete or partial clearance demonstrated clinical improvement in pain scores. Three patients underwent Whipple procedure upon failure of combination therapy. Conclusion: Shock wave lithotripsy is a safe and effective adjunct to endoscopic retrograde cholangiopancreatography in the management of large pancreatic duct stones. Mo1388 Can Endoscopic Papillectomy Be Curative for Early Adenocarcinoma of the Ampulla of Vater? Ines Oria 1, Olivia B. Luna 1, María-Victoria Alvarez-Sanchez 2, Christine Lefort 1, Rodica Gincul 3, Jean-Yves Scoazec 4, Fabien Fumex 1, Dr Raphael Bourdariat 1, Dr Vincent Lépilliez 1, Anne Isabelle Lemaistre 5, Bertrand Napoleon* 1 1 Hopital Prive Jean Mermoz, Lyon, France; 2 Gastroenterology, Pontevedra hospital, Pontevedra, Spain; 3 Endoscopy, Ed Herriot hospital, Lyon, France; 4 Pathology, Gustave Roussy, Villejuif, France; 5 Pathology, Centre Léon Bérard, Lyon, France Introduction: According to the TNM classification of ampullary tumors, pt1 adenocarcinoma is limited to the ampulla of Vater without infiltration of the duodenal muscularis propria. The risk of lymph node metastasis (N +) is approximately 20% in Western surgical series. The Japanese classification subdivide pt1 lesions into d0 tumours, confined to the sphincter of Oddi (risk N+ Z 0%), and d1 tumours invading the duodenal submucosa (risk N+ Z 30%). Japanese surgeons consider a d0 lesion without vascular thrombi, as an early cancer that should be cured by a local resection. Aim. To evaluate in which cases an endoscopic papillectomy (EP) could be considered as curative in ampullary adenocarcinoma. Materials and Methods: From May 1999 to July 2013, 172 patients with ampullary tumors (adenoma +/- adenocarcinoma), staged as ut1 at endoscopic ultrasound, underwent EP and were prospectively included in a database. Adenocarcinoma was present on the resected specimen in 25 cases. An elective pancreaticoduodenectomy (PD) was proposed in cases of positive resection margins (R1), neoplastic thrombi, or submucosal invasion. In 11 cases (Group 1), the tumour was staged d0 ; in 14 cases (Group 2) the tumour was staged d1. Histopathological data and follow-up (FU) of patients were analyzed retrospectively. Results: No patient was lost of FU. Group 1 (nz11): Five patients (45%) had negative margins of resection (R0), no neoplastic thrombi and normal biopsies at the post resection control. No recurrence was evidenced during FU (mean 56 months (18-96)). Six patients (55%) were R1, one with neoplastic thrombi. An elective PD was done in 3 patients (1 d1n-, 1d1N+, 1 without residual tumor). Three patients had contraindications or refused surgery and were followed. There was no cancer recurrence or disease related death in two cases (FU: 36 and 72 months). One patient had a cancer recurrence and was finally operated on 6 months later (pt3n+).group 2 (nz14): Ten patients (71%) were R1 and four (29%) R0. Neoplastic thrombi were present in 5 cases (36%). An elective PD was done in 8 patients ; 6 were N + (62%) +/- residual adenocarcinoma (nz4; 50%) and two were free of tumor. The other six patients had contraindications or refused surgery. During FU (mean 24 months (12-48)) the cancer recurred in 3 patients (1N +, 1 local recurrence, 1 M+ liver), 2 patients died from complications of chemotherapy and one remained alive without recurrence at 24 months. Conclusion: In agreement AB402 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
8 with the Japanese classification, EP was curative in 100% of cases when the resected specimen revealed an adenocarcinoma limited to the Oddi s sphincter, no neoplastic thrombi, and R0 resection. In the other cases EP was curative in only 28% and PD should be systematically discussed. Mo1389 Extracorporeal Shock Wave Lithotripsy (ESWL) Followed by Same Day Endoscopic Treatment for the Management of Pain in Chronic Calcific Pancreatitis (Ccp). a Single Center Experience Mariano Gonzalez-Haba Ruiz*, Emmanuel Coronel, Uzma D. Siddiqui, Vani J. Konda, Irving Waxman, Andres Gelrud Center for Endoscopic Research and Therapeutics, The University of Chicago Medicine, Chicago, IL Background: Pancreatic duct (PD) calculi are common in patients with CCP, and can be a major cause of pain due to obstruction with upstream ductal dilation. ESWL is an alternative to surgery in patients with large stones not amenable to simple endoscopic removal. The aim of this study is to determine usefulness and success of ESWL followed by ERCP for the treatment of painful CCP. Methods: A retrospective review of patients with severe pain from CCP who underwent treatment with ESWL was performed. ESWL was performed in the ERCP room under fluoroscopic guidance. ERCP was performed immediately before ESWL to facilitate locating stones (and when possible to place an oro-pancreatic irrigation catheter) and after ESWL for stone removal. Follow up ERCP was performed within 3 months for stent extraction and further stone removal. Technical success was defined as stone fragmentation to allow subsequent endoscopic extraction. Clinical success was defined as improvement on a numeric pain scale (NRS-11). Results: Eight patients underwent ESWL between March 2012 and Sept /8 had previous failed endoscopic therapy. All patients had embedded large stones (average size 11.12mm, range 7-19mm) with significant proximal PD dilation. 7/8 were smokers. Etiology of CCP was alcohol & tobacco in 62.5% (5/8), hereditary (1/8) and likely tobacco (2/8). Median age was 51.5 years (range 15-65), 7/8 were male. All patients underwent a single ESWL and a total of 23 ERCP procedures (average 2.86, 1-5). Mean number of shocks applied were 5660 ( ). Stone fragmentation was obtained in all cases and immediate ERCP with partial stone removal in 7/8 patients. There was no mortality or major complications. Minor complications included premature ventricular contractions during ESWL in one patient and significant post procedure pain in 3/8 patients (43%), all discharged after 24h. One patient had macroscopic hematuria for 48h without clinical implications. Mean baseline chronic pain was 8.1/10 (range 5-10). Complete resolution of pain was achieved in 4/8 patients after a mean follow up of 13.92months (range 2-32). 2/8 patients had significant (O50% of NRS-11) but incomplete resolution and 2/8 patients underwent surgery, one for persistent pain and one for recurrent pain after 24 months of complete remission. One surgical patient had persistent pain after pancreatic decompression. Conclusions: ESWL followed by same day ERCP with stone extraction and stent placement is a safe and effective treatment in painful CCP with head predominant disease, large PD stones and dilated upstream PD, who decline surgery or are poor surgical candidates. All had technical success with complete or significant resolution of pain in 75%. The literature favors surgery over endoscopic therapy in CCP, but no randomized studies comparing ESWL to surgery in this patient population are available. Figure 1. CT Scan showing head predominant chronic calcific pancreatitis (CPP) (right). Same patient pancreatogram showing PD dilation during ESWL/ERCP procedure Figure 2. Subsequent ERCP showing pancreatic duct stones after endoscopic removal Mo1390 Is There a Benefit in Exocrine and Endocrine Function With the Use of Extracorporeal Shock Wave Lithotripsy in Chronic Calcific Pancreatitis Management: a Meta-Analysis and Systematic Review Harsha Moole* 1, Amy L. Jaeger 1, Matthew L. Bechtold 2, Srinivas R. Puli 3 1 Department of Internal Medicine, University of Illinois College of Medicine Peoria, Peoria, IL; 2 Department of Gastroenterology and Hepatology, University of Missouri, Columbia, MO; 3 Department of Gastroenterology and Hepatology, University of Illinois College of Medicine Peoria, Peoria, IL Background: Morbidity in chronic calcific pancreatitis has been attributed to calcified pancreatic duct (PD) stones. Extracorporeal shock wave lithotripsy (ESWL) is one of the management options for chronic calcific pancreatitis. The effect of ESWL on endocrine and exocrine functions of pancreas is not clear. This is a meta-analysis and systematic review to assess the overall endocrine and exocrine outcomes with the use of ESWL in chronic calcific pancreatitis. Aim: To evaluate exocrine and endocrine outcomes with the use of ESWL in chronic calcific pancreatitis. Primary outcomes are weight gain, quantity of anti-diabetic medication and number of patients with diabetes before and after ESWL management. Complications of ESWL have also been evaluated. Method: Study Selection Criterion: Studies using ESWL in chronic calcific pancreatitis Data collection & extraction: Articles were searched in Medline, Pubmed, Ovid journals, CINAH, International pharmaceutical abstracts, old Medline, Medline nonindexed citations, and Cochrane Central Register of Controlled Trials & Database of Systematic Reviews. Two reviewers independently searched and extracted data. Any differences were resolved by mutual agreement. Statistical Method: Pooled proportions were calculated using both Mantel-Haenszel method (fixed effects model) and DerSimonian Laird method (random effects model). The heterogeneity among studies was tested using Cochran s Q test based upon inverse variance weights. Results: Initial search identified 1,471 reference articles, in which 184 articles were selected and reviewed. Data was extracted from 27 studies (NZ3189) of ESWL in the management of chronic calcific pancreatitis, which met the inclusion criterion. When managing chronic pancreatitis pancreatic duct stones with the use of ESWL, the pooled proportion of patients requiring decreased quantity of anti-diabetic medications after ESWL management was 5.15% (95% CI Z 3.88 to 6.58). The number of patients with diabetes before and after ESWL management were 31.27% (95% CI Z to 33.53) and 37.90% (95% CI Z to 42.34) respectively. Patient s weight was constant or increased in 81.45% (95% CI Z to 84.11) of the pooled patients, and weight decrease was noted in 7.90% (95% CI Z 6.06 to 9.95). ESWL associated pancreatitis was noted in 4.2% (95% CI Z 3.42 to 5.18). After management with ESWL, 4.4% (95% CI Z 3.62 to 5.35) of the pooled patients required surgery for various reasons. Conclusion: ESWL might have improved exocrine function of the pancreas manifested by either constant or increased body weight in majority of the patients. Endocrine function was not significantly different before and after the ESWL management in patients with chronic calcific pancreatitis. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB403
9 Mo1391 The Usefulness of Concurrent Use of Fully Covered Self-Expandable Metal Stentsand Plastic Stentsin Benign Pancreatic Ductal Stricture Dongwook Oh*, Sang Soo Lee, Tae Jun Song, Do Hyun Park, Dong Wan Seo, Sung Koo Lee, Myung-Hwan Kim Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea (the Republic of) Background and Aims: Recently, fully covered self-expandable metal stents (FCSEMSs) has been used for pancreatic ductal strictures in chronic pancreatitis. However, distal stent migration and stent-induced ductal stricture are not uncommon. The purpose of this study was to investigate the feasibility, efficacy, safety of concurrent use offcsemssand plastic stentsin patients with benign pancreatic ductal stricture. Patients and Methods: We retrospectively reviewed the data of 18 patients who received endoscopic treatment with concurrent FCSEMSsand plastic stents for the benign pancreatic ductal stricture between August 2011 and November Additional plastic stents, which were longer than FCSEMSs, were inserted through FCSEMSs lumen. Results: Stents placement was successful through the major (nz11) or minor papilla (nz7). All patients could achieve pain relief after stents placement. In all patients,stents could be easily removed median 181 days (range from 68 to 181days) after stents insertion. There was no distal or proximal stent migration. Ductal stricture was resolved in 16 (88.9%) patients. During follow-up periods (median 527 days, range from 127 to 963 days), stent-induced ductal stricture did not developed after stent removal. Conclusions: The concurrent use of FCSEMSs and plastic stentsmay be safeand effective in the treatment of benign pancreatic ductal stricture. Baseline characteristics Median age (20-79) Gender Male 10 Female 8 Etiology Alcohol 6/18 (33.3%) Hereditary 6/18 (33.3%) Idiopathic 4/18 (22.2%) Divisum 2/18 (11.1%) Pancreaticolith 17/18 (94.4%) Clinical outcomes Location of stricture Head 12/18 (66.7%) Neck 4/18 (22.2%) Body 2/18 (11.1%) Cannulation Major 11/18 (61.1%) Minor 7/18 (38.9%) Balloon dilatation 11/18 (61.1%) Stent type Metal stent 6mm 5cm 2/18 (11.1%) 6mm 6cm 9/18 (50%) 6mm 7cm 6/18 (33.3%) 6mm 8cm 1/18 (5.6%) Plastic stent 7Fr 9cm 1/18 (5.6%) 7Fr 11cm 1/18 (5.6%) 7Fr 12cm 15/18 (83.2%) 7Fr 14cm 1/18 (5.6%) Stent placement 18/18 (100%) Stent removal 18/18 (100%) Stent placement duration 324 days (91-587) Resolution of stricture 16/18 (88.9%) Adverse events 3/18 (16.7 %) Abdominal pain 2/18 (11.1%) Post-ERCP pancreatitis 1/18 (5.6%) Mo1392 Covered Metal Stent Placement Using Santorini s Duct (Minor Papilla) for Pain Management in Chronic Calcific Pancreatitis - Feasibility and Safety Arvind Sangwaiya*, Mohammed A. Butt, Rameshshanker Rajaratnam, Stelios Papasavvas, Christopher A. Wadsworth, Devinder Bansi, Panagiotis Vlavianos, David Westaby Gastroenterology, Imperial College Healthcare NHS Trust, London, United Kingdom Background: Pain control in chronic calcific pancreatitis is often unsatisfactory. Both endoscopic and surgical drainage procedures have been described for management of intractable or recurrent severe pain. Pancreatojejunostomy has been shown to be more effective than endoscopic management (using plastic stents) of main pancreatic duct stricture (PDS). 1, 2,. Recently fully covered-self expanding metal stent (FC-SEMS) placement across PDS has been assessed as a new endoscopic approach with the aim of achieving enhanced PD drainage 3, 4. As a part of a larger series, we have identified 8 cases in which access for PD drainage has been achieved via Santorini s Duct. Aim: To assess safety and feasibility of FC-SEMS using Santorini s Duct in treatment of PDS in chronic pancreatitis. Methods: 8 patients (M:F 3:5 mean age 58 years) had FC-SEMS placed using Santorini s Duct. 5 patients had pancreatic divisum confirmed on imaging and ERCP. 5 patients had prior placement of plastic stents and 3 had no prior endoprostheses. Planned outpatient follow up was at 3, 6 and 12 months. Mean duration of stent insertion was 3 months and response (i.e. pain control) was assessed at 3 months by using a 1-10 visual analog scale to compare pre- and post-intervention symptoms. A score of 2 or less was classified as complete response, whereas a score of 3 or above was classified as partial response or if there was an improvement by 4 or more points in the scale. Results: FC-SEMS insertion using Santorini s Duct was feasible in all patients. The SEMS was removed at a median of 3 months (range 1.2 to 4 months). Mean follow up duration was 8.7 months. 5 patients (62.5%) reported complete response to pain while 2 (25%) had a partial response. One (12.5%) patient reported no response post endotherapy and was considered for surgical drainage. In one patient (partial response) the stricture had not resolved on SEMS withdrawal. A short stricture at the upstream stent margin was seen in one patient and responded to balloon dilatation. There were no instances of stent migration. Conclusion: We describe the first series reporting the use of Santorini s Duct to deliver FC-SEMS in PDS due to chronic pancreatitis. This approach is feasible, safe with early evidence of efficacy. The duration of duct patency and as a consequence success of pain management requires longer term follow up. Reference:1. Cahen et al N Engl J Med Feb 15;356(7): Roch et al J Gastrointest Surg Jul;16(7): doi: /s Dumonceau et al Endoscopy 2012; 44(08): DOI: /s Seza et al Hepatogastroenterology Nov-Dec;58(112): doi: / hge Demographics Number Sex Age Denovo (N) or Reque(R) Main Duct(M) Pancreatic Santorini(S) divisum Pain response C Complete, P Partial, N Nil Follow up months Complications SEMS removed (months) Observation 1 F 66 R S Yes P 8 None F 55 N S Yes C 13.5 None 3 3 F 68 R S No C 14.5 None 4 4 F 55 R S No N 9 None 3 SEMS stricture responding to balloon dilatation 5 M 41 R S Yes C 12 None 3 6 M 54 R S Yes C 8 None 4 7 M 65 N S Yes P 2 None 1.2 persistent stricture 8 F 62 N S No C 3 None 3 Mo1393 Is ESWL Without ERCP Suitable As a Primary Treatment Modality for Patients With Chronic Pancreatitis in Tropical Countries: Does the Stone Load Matter? Suryaprakash Bhandari*, Atul Sharma, Mukta Bapat, Nitin Joshi, Vishal Bothara, Vinay K. Dhir, Amit P. Maydeo Baldota Institute of Digestive Sciences, Mumbai, India Background: ESWL only without ERCP has been advocated as a primary treatment modality for patients with chronic pancreatitis. However patients suitable for such a therapy are not defined. Aim: 1. To identify the number of patients having spontaneous ductal clearance at ERCP after ESWL. 2. Measure pain relief post ESWL. Materials and Methods: Retrospective analysis of symptomatic patients undergoing ESWL/ERCP during January 2013-June Patients were divided into low stone load category (! 2cm, nz14), high stone load category (2-5 cm, nz16) and very high stone load category (5-10 cm, nz15). ESWL was done using Dornier Delta II compact lithotripter. ERCP, pancreatic sphincterotomy and stone extraction was AB404 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
10 done three days after ESWL. Stents were placed in the duct only if PD clearance was incomplete. Results: 45 patients having uniformly dilated pancreatic duct with single/ multiple calculi underwent ESWL and ERCP during study period. Patients having low stone load had maximum spontaneous ductal clearance at ERCP (11/14 [ 78%] vs 0/ 31, pz 0.001). Patients having high and very high stone load required basket extraction of stone irrespective of good pulverization (3/14 [21 %] vs 0/32, pz0.001) Pain relief after ESWL was excellent in patients with lower stone load as compared to category II and category III patients (11/14 [78%] vs. 2/31[6%], p Z0.005). Complications: ESWL related gastric and duodenal hematoma (nz2), self limited pancreatitis (nz4). Conclusions: Patients having low stone load had maximum spontaneous ductal clearance at ERCP (78%) as compared to category II and III patients and ESWL alone can be a therapeutic option in these patients. However, further prospective studies with larger patient population are required to confirm our findings. Table 1. Comparison of outcome of ESWL in all patients Events Low stone Load (n[14) High Stone Load (n[16) Very High Stone Load (n[15) p value Spontaneous PD 11 None None stone clearence Basket Extraction required Pain relief 11(78%) 2(12.5%) None Technical Success Yes Yes Yes - No. of ESWL sessions 2 (1-2) 3 (2-4) 5 (4-6) - [median(range)] ESWL related None None 2 - hematoma formation ESWL related None None None - pancreatitis PD: Pancreatic Duct P value compares outcome betwen low stone load and combined high & very high stone load Mo1394 Timing of ERCP and Outcomes of Patients With Acute Gallstone Pancreatitis: a Nationwide Population Based Study Tarun Rustagi*, Basile Njei Section of Digestive Diseases, Yale University School of Medicine, New Haven, CT Background: The role and timing of ERCP in acute gallstone pancreatitis remains controversial. There is limited data on the impact of timing of ERCP on acute gallstone pancreatitis outcomes. The aim of this study is to assess the impact of timing of ERCP on outcomes of patients with acute gallstone pancreatitis, with or without co-existing cholangitis or biliary obstruction. Methods: In this cross-sectional study of the National inpatient sample database 2010, ICD-9 codes identified patients with acute gallstone pancreatitis who underwent ERCP. We excluded admissions in which ERCP had been performed on or before the day of admission as they may reflect cases of post-ercp pancreatitis. The main outcome measurements were in-hospital mortality, length of stay (LOS) and hospitalization charges based on the timing of ERCP. Multivariate logistic regression was used to adjust for demographic variables and covariates while determining the impact of the timing of ERCP on in-hospital mortality. Covariates included: age, sex, race, type of health insurance, weekend admission status, hospital location, hospital teaching status, and hospital annual ERCP volume. Multivariable Cox proportional hazards and linear regression models were used to predict LOS, and hospital charges, respectively. Subgroup analysis limited to discharges with concomitant cholangitis or biliary obstruction was done. Results: A total of 14,411 discharges with acute gallstone pancreatitis were identified. Among these, 4,756 patients (33%) had an ERCP performed during the hospitalization: 3,710 patients (78%) had ERCP performed within 72 hours (early ERCP cohort), and 1,046 patients had ERCP performed after 72 hours (delayed ERCP cohort). Overall, there was no difference in mortality in patients with acute gallstone pancreatitis who had early vs. delayed ERCP (0.8% vs. 1.2%, pz0.68). However, patients in the early ERCP group had a shorter LOS (5 vs. 7 days, pz0.01), and lower hospitalization charges ($23,873 vs. $36,265, p!0.001). On multivariate analysis, timing of ERCP did not impact mortality (adjusted odds ratio [aor], 1.10; 95% CI, ); but delayed ERCP was associated with increase in LOS by 2 days and increase in hospitalization charges by $5,456. In our subgroup multivariate analysis limited to acute gallstone pancreatitis patients with co-existing cholangitis or biliary obstruction (nz6,485), in addition to increase in LOS and hospitalization charges, delayed ERCP was associated with a significant increase in mortality (aor, 1.51; 95% CI, ). Conclusions: Early ERCP within 72 hours is associated with decreased length of stay and hospitalization charges in patients with acute gallstone pancreatitis. In addition, our results provide support for current recommendations that early ERCP should be considered in patients with co-existing cholangitis or biliary obstruction. Mo1395 Endoscopic Management of Internally Migrated Pancreatic Duct Stents At a Tertiary Care Centre in India Suryaprakash Bhandari*, Atul Sharma, Mukta Bapat, Nitin Joshi, Vinay K. Dhir, Amit P. Maydeo Baldota Institute of Digestive Sciences, Mumbai, India Background: Spontaneous intestinal migration of pancreatic stents is a known phenomenon. However retrieval of an internally (proximally) migrated pancreatic stent poses a therapeutic challenge. Aim: To assess the safety and efficacy of ERCP for extraction of proximally migrated pancreatic stents. Study design: Retrospective single centre evaluation Setting: Tertiary referral centre. Patients: Diagnosed patients with proximal migrated stents on imaging.main outcome measures: Success at endoscopic stent extraction, adverse events and need for surgery. Results: Nine patients were found to have internal migration of the PD stent during study period (January 2007-August 2014). Four patients had retropapillary migration of stent with proximal end seen till genu (Level 1), the rest had stents migrated beyond genu (Level II). Stents were placed due to following reasons, prophylactic PD stenting after CBD stone extraction (nz3), pancreatic endotherapy for chronic pancreatitis (nz6). 3Fr, 5Fr & 7Fr stents were placed in one, five and three patients respectively. Two patients had migrated pig tail stent, rest had straight stents. Table shows details of all patients including demography, number of sessions required for stent retrieval, method of retrieval, technical success and complications encountered. Conclusions: Endotherapy of internally migrated pancreatic stents could be complex, and associated with adverse events. Deeply migrated PD stents (Level II) may require specialized methods like spyglass pancreatoscopy for stent retrieval. Table 1. Shows details of all patients including demography, number of sessions required for stent retrieval, method of retrieval, technical success and complications encountered. Case No Level of stent migration Level I Level II Age (Yrs) Sex F F F M M M F M F Stent position Proximal body Mid body-tail Tail Mid body-tail Genu Retropapillary Genu Genu Stricture in head Mid bodytail Dilated PD No No No 6mm 8mm 7mm 8mm 6mm 7mm Stent size 5/7 5/7 5/7 7/10 5/7 7/10 5/7 3/5 7/10 (Fr/Cm) Stent type Straight Pigtail Straight Straight Reverse Straight Straight Straight Straight pigtail No of sessions Post CBD Yes Yes Yes No No No No No No stone extraction PD stenting PD stenting No No No Yes Yes Yes Yes Yes Yes for Chronic Pancreatitis Retrieval method Rat tooth forceps Rat tooth forceps Balloon Spy Spy Spy Lasso technique Technical success Complications Over the wire snare technique Over the wire snare technique Yes Yes Yes Yes Yes Yes Yes Yes Yes Mild acute pancreatitis Minor bleeding Nil Nil Nil Mild acute pancreatitis Minor bleeding Mo1396 Endotherapy for Pancreatic Ductal Disruption: a Dual Center Experience Rohit Das* 1, Georgios I. Papachristou 1, Adam Slivka 1, Jeffrey J. Easler 2, Dhiraj Yadav 1, Jennifer Chennat 1, Mordechai Rabinovitz 1, Jessica Malin 3, Justin B. Herman 3, Sobia N. Laique 3, Umar Hayat 3, Yinn Shaung Ooi 3, Ali Siddiqui 3 1 University of Pittsburgh Medical Center, Pittsburgh, PA; 2 Indiana University of Medicine, Indianopolis, IN; 3 Thomas Jefferson University Hospital, Philadelphia, PA Background: Pancreatic duct (PD) disruptions can occur from different etiologies (e.g. acute (AP) or chronic pancreatitis, pancreatic surgery, abdominal trauma) and can be managed medically, endoscopically, or surgically. When compared with surgery, endotherapy is a less invasive approach. Previous studies from 2002 and Pain Nil Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB405
11 2005 report an overall success rate for endoscopic therapy of 60%. Our aim was to provide an update over the last 5 years on the efficacy of endotherapy in successfully treating PD disruption in a large cohort of patients and assess for factors predicting successful outcome. Methods: We retrospectively evaluated consecutive patients who underwent an endoscopic retrograde pancreatography (ERP) for stenting of PD disruption from 2008 to 2013 at two referral institutions. PD disruption was defined as extravasation of contrast from the pancreatic duct seen on ERP. Data was assembled on patient demographics, etiology of PD disruption, ERP findings, procedural details and complications, and mortality. Therapeutic success was defined by resolution of PD leak seen on ERP and clinical and/or imaging resolution of peripancreatic fluid collections, pleural effusions or ascites. Follow up was obtained by review of imaging studies and medical records. Results: We evaluated 120 patients (58% male, mean age 53 years). Etiology of PD disruption included AP (39%), chronic pancreatitis (23%), post-operative (21%), trauma (3%), and other (14%). ERP with deep pancreatic cannulation was achieved in all patients. A pancreatic sphincterotomy was performed in 47 (39%) patients. PD leaks were seen in the pancreatic head in 31%, body in 28%, tail in 30%, and were multi-focal in 10%. PD disruption was bridged by a stent in 45 (38%) patients; the median stent size was 5 French. Of head PD leaks 43% were bridged, of body leaks 41%, and of tail leaks 21%. Two patients developed post-sphincterotomy bleeding and 2 had stent migration. Therapeutic success was achieved in 95 (79%) patients. Of therapeutic failures, 35% required operative intervention. Female gender, PD disruption in the tail, PD stenting across the disruption, and longer PD stent duration were associated with a higher likelihood of therapeutic success (p!0.05, Table 1). On multivariate analysis, only PD disruption in the tail (ORZ6.2, 95% CIZ ) and stenting across the disruption (ORZ7.3, 95% CIZ ) remained independently associated with therapeutic success. On follow up, 10 recurrences occurred; the mean time to recurrence was 13 months. Of these patients, 6 were treated successfully with repeat endotherapy. Conclusions: Endoscopic therapy for PD disruption is safe and effective. PD leaks from the tail have a favorable endoscopic outcome. Bridging across the site of PD disruption significantly increases endotherapy success, but was achieved in less than half of patients. Table 1. Univariate Analysis of Factors Impacting Endoscopic Outcome Total (n [120) Successful (n [95) Failed (n [25) p- value Age, years (SD) 53 (16) 53 (15) 51 (19) Gender, male 58% 54% 76% Non-AP etiologies 61% 65% 44% Time to index ERP, days (SD) 34 (53) 30 (44) 51 (79) Octreotide use 35% 34% 40% Percutaneous Drain 51% 49% 56% Placement PD leak site in tail 32% 37% 12% PD stenting across 38% 44% 13% disruption PD stent size O 7 Fr 44% 45% 38% Duration of PD stenting, 77 (68) 82 (71) 54 (53) days (SD) Pancreatic Sphincterotomy 39% 42% 28% ERP Complicatioms N/A Mo1397 Endoscopic Role in the Diagnosis of Patients With IgG4-Related Sclerosing Cholangitis Ken Ishii*, Kensuke Kubota, Sho Hasegawa, Yuji Fujita, Yusuke Sekino, Kunihiro Hosono, Atsushi Nakajima Yokohama City University, Graduate School of Medicine, Gastroenterology and Hepatology, Yokohama, Japan Background: A differential diagnosis of IgG4-related sclerosing cholangitis (IgG4-SC) and others has been challenging. Nakazawa (Pancreas 2006;32:229) presented a classification for IgG4-SC based on cholangiography. However, some atypical IgG4- SC cases have been reported. Aim: To clarify the usefulness of cholangiography, endoscopic features, narrow band imaging (NBI) findings, and endoscopic biopsy results using immunostaining of the bile duct and ampulla in the differential diagnosis of indeterminate biliary strictures. Methods: We performed a cohort study examining patients with proximal type IgG4-SC (n Z 40), primary sclerosing cholangitis (PSC) (n Z 25) and Klatskin tumor (n Z 118). Those findings might be useful in the differential diagnosis were evaluated; cholangiography such as long stricture without obstruction (LSWO), Intraductal ultrasonography features showing symmetric regular mucosal thickness (SRMT), endoscopic features; the NBI to evaluate typical sub-mucosal swelling of the ampulla (SW) and enhanced abnormal hyper-vascularity on the surface of Vater (NBI-E), endoscopic biopsy using IgG4- immunostaining in bile duct and ampulla. Result: Autoimmune pancreatitis (AIP) relapsed as Nakazawa type 2, 3 or 4 in 28 patients. IgG4-SC patients without AIP consisted of 7 patients with Nakazawa type 4 and 5 patients with atypical nodular type. LSWO was observed in 87.5% (35/40) of the patients with IgG4-SC, which was a significantly higher percentage than in patients with PSC (4%, 1/25) or Klatskin tumors (8%, 9/118). SW was observed in 68% (23/34) of the patients with IgG4-SC, which was a significantly higher percentage than in patients with PSC (4%, 1/25) or Klatskin tumors (8%, 9/118). NBI-E was observed in 90% (9/10) of the patients with IgG4-SC, which was a significantly higher percentage than in patients with PSC (0%, 0/10) or Klatskin tumors (25%, 3/12). SRMT was observed in 85% (11/13) of the patients with IgG4-SC, which was a significantly higher percentage than in patients with PSC (38%, 5/13) or Klatskin tumors (21%, 8/39). Endoscopic biopsy findings from the bile duct did not contribute to the diagnosis of IgG4-SC, PSC, or Klatskin tumors. Endoscopic biopsy findings from the ampulla were significantly observed in 68% (15/22) of the patients with IgG4-SC, which was a significantly higher percentage than in patients with PSC (8%, 1/13) or Klatskin tumors (0%, 0/13). In the atypical IgG4-SC cases with a nodular lesion, none of the above-mentioned endoscopic findings contributed. Conclusion: Most IgG4-SC lesions can be differentiated from PSC and Klatskin tumors using endoscopic methods, such as a cholangiography, endoscopic ampulla features using NBI, and a biopsy using IgG4 immunostaining. However, the diagnosis of nodular-type IgG4-SC is difficult; therefore, a steroid trial could be considered. Mo1398 Single Operator PerOral Pancreatoscopy for Main Duct Intraductal Papillary Mucinous Neoplasm Is Highly Specific but Has Poor Sensitivity Aaron J. Small* 1, Gregory Lutzak 2, Seng-Ian Gan 1, Shayan Irani 1, Michael Gluck 1, Michael C. Larsen 1, Andrew S. Ross 1, Richard A. Kozarek 1 1 Gastroenterology, Virginia Mason Medical Center, Seattle, WA; 2 Gastroenterology, Royal Alexandra Hospital, University of Alberta, Edmonton, AB, Canada Background: Patients with IPMN should be considered for surgery if there is involvement of the main duct. Peroral pancreatoscopy (Spyglass) allows for direct intraductal visualization that may aid in the evaluation of main duct IPMN (MD-IPMN). Objective: To determine the performance characteristics of Spyglass in the evaluation of MD-IPMN. Methods: Retrospective review of patients with a dilated pancreatic duct who underwent Spyglass pancreatoscopy for evaluation of IPMN over a tenyear period at a single center. The endoscopist s diagnosis at the time of Spyglass was compared to the diagnosis made following completion of the medical evaluation with surgical specimens when available. Results: 37 of 51 patients who underwent pancreatoscopy during the study period had endoscopic evaluation for MD-IPMN. Spyglass was used on 25 of these patients (13 M; median age 66, IQR: 59, 72). The targeted region of the pancreas was reached in all (96%) but one case (pancreatic cyst in the head): 24% distal body/tail, 28% proximal/mid body, 48% genu or head of pancreas. There was a single adverse event (4%); post-ercp pancreatitis. 13 patients were referred for surgical resection. 15.4% (2 /13) of those who underwent an operation had dysplasia (1) or cancer (1) on resection. Overall, Spyglass pancreatoscopy had a 100% specificity, 66.7% sensitivity, PPV of 100%, and NPV of 76.5% for diagnosing MD-IPMN. Concordance in the pancreatoscopic impression and final diagnosis based on histopathology occurred in 84% (21 /25). Spyglass directed biopsies were taken in 28% (7 /25). Concomitant brushings were taken in 9 patients. There was concordance of the histopathologic results from the biopsies (including 2 with non-directed biopsies) and brushings in 55.6% (5 /9). Spyglass directed biopsies had a 45.5% sensitivity, 100% specificity, PPV of 100%, and NPV of 40% in the diagnosis of IPMN or neoplasia (1) when using surgical specimens as the gold standard. There was no difference in diagnostic accuracy when comparing Spyglass with older Olympus prototypes (12 patients) used to investigate for IPMN main duct involvement [Olympus: sensitivity 80% (pz 0.52), specificity 100%, PPV 100%, NPV 50% (pz 0.32)]. Similarly, there was no difference in the diagnostic accuracy (normal /inflammation vs. IPMN /dysplasia) of Spyglass directed biopsies as compared to targeted biopsies taken with Olympus prototypes [Olympus: sensitivity 50% (pz 0.65), specificity 100%, PPV 100%, NPV 33.3% (pz0.69)]. Conclusions: 1] Pancreatoscopy is technically feasible and safe in investigating both the distal and proximal main duct when the duct is significantly dilated. 2] Spyglass pancreatoscopy is highly specific for MD-IPMN and effectively rules in patients with main duct involvement of an intraductal lesion. 3] Diagnostic accuracy and yield of Spyglass directed biopsies is comparable to older prototypes. Mo1399 Preoperative Histological Subtype Classification of Intraductal Papillary Mucinous Neoplasms (IPMN) by Pancreatic Juice Cytology With MUC Stain Taro Hara*, Dai Ikebe, Emiri Kita, Taketo Yamaguchi Chiba Cancer Center, Chiba, Japan Objective: To prospectively evaluate the diagnostic value of preoperative histological subtyping of intraductal papillary mucinous neoplasms (IPMNs) by pancreatic juice cytology (PJC) with mucin (MUC) stain. Background: IPMNs are classified into four subtypes based on their histomorphology and mucin phenotype, and varied degrees AB406 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
12 of malignant nature and prognosis among these subtypes have been shown. Methods: The subjects were 62 patients with surgically confirmed IPMNs, who underwent PJC preoperatively by endoscopic retrograde cholangiopancreatography. Histological subtyping of cytological samples with or without MUC stain (MUC1, MUC2, and MUC5AC) was compared with that of resected specimens. Results: Histologically, low-grade dysplasia was found in 4 patients, intermediate in 19, high grade in 19, and invasive carcinoma in 20. Gastric, intestinal, pancreatobiliary, and oncocytic subtypes corresponded to 29, 24, 8, and 1 patient, respectively. The rate of high-grade dysplasia (HGD) and/or invasive IPMNs was 34.4% for gastric subtype, 87.5% for intestinal subtype, and 100% for both pancreatobiliary and oncocytic subtypes, showing a significant correlation between histological subtype and rate of HGD and/or invasive IPMN(P! 0.01 for gastric vs nongastric). Histological subtype was successfully diagnosed by PJC in 90.3% (56/62) with MUC stain.the sensitivity, specificity, and overall accuracy of PJC with MUC stain were 91%, 100%, and 95% for intestinal subtype, respectively. On the other hand, PJC based on the grade of cellular dysplasia showed sensitivity of 37.8%, specificity 100%, and 62.9% accuracy. Conclusions: Preoperative PJC with MUC stain proved to be highly reliable for identifying the histological subtype of IPMN and may provide useful information for deciding surgical indication. Mo1400 Clinical Usefulness of PerOral Pancreatoscopy for Preoperative Diagnosis of Intraductal Papillary Mucinous Neoplasms Emiri Kita*, Taro Hara, Taketo Yamaguchi, Kentaro Sudo, Kazuyoshi Nakamura Gastroenterology, Chiba Cancer Center, Chiba, Japan Background and Aim: Preoperative evaluation of the malignant potential and surgical margin is particularly important for the management of intraductal papillary mucinous neoplasms (IPMNs). Peroral pancreatoscopy (POPS) has improved the accuracy of the diagnosis. The aim of this study was to evaluate the clinical usefulness of POPS in patients with IPMN. Patients and Methods: Twenty-eight consecutive patients with IPMN (main duct type/mixed type: 14/14) underwent POPS (Spyglass/ OlympusB260: 16/12). Visual images and histopathological findings obtained using POPS were compared with resected specimens. We evaluated the visual diagnosis (morphology of the main lesion and tumor extension) and histopathological findings (biopsy samples and collected pancreatic juice). Correlations of the mucin subtype (gastric, intestinal, pancreatobiliary, or oncocytic) with the POPS findings and the resected specimens were also assessed. Results: Mean patient age was 69 years (range 51-79), with 19 males and 9 females. Intermediate-grade dysplasia, high grade dysplasia, and invasive carcinoma were 8, 14, and 6, respectively. Mucin subtypes were intestinal (n Z 16), gastric (n Z 6), pancreatobiliary (n Z 4), and oncocytic (n Z 2). The scope was inserted through the major papilla in all cases. The success rate of insertion into the main lesion was 93% (26/28) and into the proximal pancreatic duct from the lesion was 100% (28/28). The surgical margin was negative for all patients. The types of the protruding lesions assessed by POPS were granular (n Z 15), fish-egg-like (n Z 12), villous (n Z 15), and vegetative (n Z 18). Villous and vegetative types are known to be predominant in high grade dysplasia or invasive carcinoma. If these 2 types were diagnosed as malignant, sensitivity, specificity, and accuracy of POPS were 90%, 71%, and 86%, respectively. Histopathologically, pancreatic juice samples were obtained from all patients and biopsies under direct vision were performed in 12 patients. Adequate biopsy specimens were obtained from 11 patients (92%). The diagnosis of malignancy using histopathological samples were 50%, 83%, and 61%, respectively.in terms of the mucin subtype, the villous type was observed specifically in intestinal type IPMNs (15 of 15; 100%). The mucin subtypes of histopathological samples of POPS corresponded well to the resected specimens (sensitivity, specificity, and accuracy: 90%, 100%, 94%). There was 1 case of mild pancreatitis, but recovered conservatively. Conclusion: POPS demonstrated a significant advantage in the preoperative diagonsis of IPMNs. Mucin subtype will contribute to the evaluation of IPMN. Mo1401 Does Etiology of Pancreatitis Matter? Differences in Outcomes Among Patients With Post-ERCP, Acute Biliary and Alcoholic Pancreatitis Ayesha Kamal*, Venkata S. Akshintala, Vikesh K. Singh, Mohamad H. El Zein, Sepideh Besharati, Vivek Kumbhari, Saowanee Ngamruengphong, Alan H. Tieu, Eun Ji Shin, Anne Marie Lennon, Marcia I. Canto, Anthony N. Kalloo, Mouen Khashab Gastroenterology, Johns Hopkins Hospital, Baltimore, MD Background: Acute alcoholic and biliary pancreatitis are the two most common causes of acute pancreatitis worldwide. Acute pancreatitis is the most common complication of ERCP and occurs in 5-15% of procedures. Aim: To compare morbidity and mortality rates in patients with acute alcoholic pancreatitis (AAP), acute biliary pancreatitis (ABP) and post ERCP pancreatitis (PEP). Methods: This was a retrospective cohort study conducted at a tertiary care academic center. Billing database was searched for patients admitted with diagnosis of acute pancreatitis between 6/2007 and 6/2012. Patients diagnosed with PEP, AAP or ABP were included in the study. Age, gender, etiology, systemic inflammatory response syndrome (SIRS), chronic pancreatitis and BUN, were abstracted. Overall mortality was assessed as the primary outcome variable. Complications of pancreatitis, including pancreatic necrosis, pseudocyst formation, single or multi organ failure (OF) and length of hospital stay (LOHS) were assessed as secondary outcomes. These outcome variables were compared among the three types of pancreatitis using one way Anova test and Chi Square test. In multivariate analysis, logistic regression was used to identify predictors for each outcome of interest. Results: A total of 443 patients (mean age 47yr, 45% female) diagnosed with acute pancreatitis were included. Among these, 300 (68%) patients were diagnosed with AAP, 88 (20%) with ABP and 55 (12%) with PEP. The mean LOHS was 5.9 days. Overall, pseudocyst formation occurred in 87 (19.6%), pancreatic necrosis in 26 (5.9%), single OF in 55 (12.4%), MOF in 13 (2.9%) and persistent OF in 23 (5.2%) patients. A total of 35 (7.9%) patients required an intervention due to complications. The overall mortality rate was 8.8% (PEPZ4%, ABPZ11%, AAPZ9%, pz0.002). Prolonged LOHS of O 10 days was more common in ABP patients (23%) as compared to AAP (10%) and PEP (7%, pz0.025). Complications such as pseudocyst (pz0.048), OF (pz0.01), need for interventions to treat complications (pz0.001), and mortality (pz0.002) occurred more commonly in ABP patients as compared to the other groups. On multivariate analysis, SIRS on the second day of hospitalization was associated with LOHS O10 days (ORZ2.57, pz0.01) and MOF (ORZ5.3, pz0.05). History of chronic pancreatitis was associated with an increased risk of pseudocyst formation (ORZ3.87, pz0.0001) and mortality (ORZ3.79, pz0.03). BUN O25gm/dl predicted LOHS O10 days (ORZ2.43, pz0.02), OF (ORZ33.9, pz0.0001), MOF (ORZ21.6, pz0.0001) and persistent OF (ORZ45.02, pz0.0001). Conclusion: The etiology of acute pancreatitis is an important determinant of the morbidity and mortality. ABP is a more severe disease compared to PEP and AAP, with a higher risk of complications. SIRS, chronic pancreatitis and high BUN are important predictors of morbidity. Mo1402 Sphincter of Oddi Manometry: Reproducibility and Effect of Sphincterotomy in the EPISOD Study Alejandro L. Suarez* 1, Qi Angela 2, Valerie Durkalski-Mauldin 2, Peter B. Cotton 1 1 Division of Gastroenterology, Medical University of South Carolina, Charleston, SC; 2 Public Health Sciences, Medical University of South Carolina, Charleston, SC Background: Sphincter of Oddi manometry (SOM) is performed during Endoscopic Retrograde CholangioPancreatography (ERCP) to diagnose sphincter of Oddi dysfunction (SOD), which can cause biliary/pancreatic pains. Elevated pressures are treated by sphincterotomy. The reproducibility of SOM measurements and results after sphincterotomy have not been studied sufficiently. Aim: To evaluate the reproducibility of SOM and completeness of sphincterotomy. The recently published EPISOD (Evaluating Predictors and Interventions in SOD) study included 214 subjects with post-cholecystectomy pain. They were randomized into 3 arms, irrespective of the findings on manometry: biliary sphincterotomy, dual (biliary and pancreatic) sphincterotomy, and sham (no sphincterotomy). 38 subjects had both biliary and pancreatic manometries performed twice, at baseline and at repeat ERCP after 1-11 months. Results in the sham arm were examined to assess the reproducibility of manometry, and those in the treatment arms to assess whether the sphincterotomies were complete (i.e. normalized the pressure) and their clinical response measured by the recurrent abdominal pain intensity and disability (RAPID) change score (Baseline - Repeat). Results: Sham arm -14 subjects, mean age 32 (20-53) and average time to repeat study was 157 (35-341) days. 2 biliary pressures remained normal, 5 became abnormal and 7 remained abnormal. 7 pancreatic pressures remained abnormal, 2 became abnormal, 3 remained normal and 2 became normal. Both measurements were reproduced in 7 (50%). Biliary sphincterotomy arm - 15 subjects mean age 34 (21-48) and average time to repeat study was 164 (55-343) days. 8 biliary pressures remained normal, 6 normalized, and 1 became abnormal. Of the pancreatic pressures, 4 remained normal, 6 remained abnormal, and 5 became abnormal. Subjects with complete biliary sphincterotomy had a median RAPID score decrease of 47 vs 13 of the remainder. Dual sphincterotomy arm - 9 subjects, mean age 42 (28-58) and average time to repeat study was 168 (80-328) days. 3 biliary pressures remained normal and 6 normalized. 6 pancreatic pressures normalized, 2 remained abnormal, and 1 became abnormal. Subjects with complete biliary, pancreatic, or both sphincterotomies had median RAPID decrease scores of 18, 16, 15 vs 75, 76, and 75 of the remainder. Conclusion: These results confirm previous reports that SOM measurements are poorly reproducible, and add important information about the incompleteness of some sphincterotomies, particularly pancreatic. Our data may exaggerate the noted discrepancies, since only patients with continuing symptoms were restudied. It is noteworthy in the biliary sphincterotomy arm that pancreatic pressures became abnormal in several patients and the median RAPID score decreased more in subjects with complete biliary sphincterotomies. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB407
13 Mo1403 Gastrojejunal Tube Feeding: a Potential New Treatment for Sphincter of Oddi Dysfunction Type III (SODPPP) Patients With Severe Post-Prandial Pain Tae Joo Jeon* 2, Byung Kyu Park 3, Laith H. Jamil 1, Simon K. Lo 1 1 Cedars-Sinai Medical Center, Los Angeles, CA; 2 Division of Gastroenterology, Inje University Sanggye Paik Hospital, Seoul, Korea (the Republic of); 3 Division of Gastroenterology, National Health Insurance Service Ilsan Hospital, Goyang-si, Korea (the Republic of) Background: ERCP and Sphincterotomy had been widely used to evaluate and treat the Sphincter of Oddi dysfunction (SOD) type III condition until their benefit was disputed by the recent EPISOD study. Unfortunately, there is no proposed alternative to manometry-directed sphincterotomy at the present moment. Aim: To determine if gastrojejunal tube (PEGJ) feeding may have therapeutic benefits for SODPPP patients. Method: All SODPPP patients without sustained improvement after bi-ductal sphincterotomies were offered percutaneous endoscopic gastrostomy-jejunostomy tube (PEGJ) feeding. SOD III was defined by pancreatic or biliary type pain without a dilated duct or abnormal pancreatic or liver tests. PEGJ was placed in the usual fashion and inserted into the proximal antrum. PEGJ s tip location in the proximal jejunum was confirmed with fluoroscopy. Strict NPO was kept within the first 4-6 weeks. PEGJ feeding was maintained as long as these patients needed feeding to provide nutrition or pain relief. Results: Nine highly symptomatic SODPPP patients underwent PEGJ tube insertion for feeding. All were female. Median age was 41 years old (25-53). Median duration of SOD symptoms was 27 months (22-96). All but one patient had elevated pancreatic or biliary sphincter pressure. Only one patient did not have a prior cholecystectomy. Eight patients had sphincterotomy and experienced pain improvement for a short duration (median; 8 weeks) before recurrence of symptoms. The mean duration of tube feeding was 5.08 months (S.E 1.83). Seven patients reported dramatic pain improvement. Six had less number of hospitalizations or ER visits after PEGJ feeding. Five patients were satisfied with the procedure and could return to normal daily activities while on tube feeding. Only 1 patient was not satisfied because of the lack of effectiveness. The demand of analgesics was decreased in 5 patients. Complications included prolonged tube insertion site pain-2, pinkish drainage-1, and nausea-1. Persistent insertion site pain was the reason for tube removal on day 7 in on patient. There were 4 tube malfunctions (J-tube dislodgement-2, tube coiling-1, broken tube-1). PEGJ had since been removed in 5 patients (no benefit-1, dramatic clinical improvement-1, husband s disagreement-1, unsightly catheter-1, insertion site pain- 1). Interestingly, those 2 patients who had tube removal due to personal issues eventually requested PEGJ re-insertion. Conclusion: PEGJ feeding may have therapeutic benefits for the subset of highly symptomatic SOD III patients with postprandial pain exacerbations. It may represent a breakthrough in the management of these patients and should be confirmed by a larger, prospective clinical study. Number Feeding duration (months) Number of hospitalization or ER visit Patient Satisfaction Pain level Resumption of daily activities Demand of analgesics/ antidepressants, anxiolytics Weight change Decreased No Improved Yes Decreased No change 2 12 Decreased Yes Improved Yes Decreased Increased 3 7 Decreased Yes Improved Yes Decreased Increased 4 16 Decreased Yes Improved Yes Decreased Increased 5 2 Decreased Yes Improved Yes Decreased Increased 6 1 N/A Yes Improved N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Improved No N/A No change N/A N/A N/A N/A N/A No change N/A: not accessible Mo1404 Outcomes of Endoscopic Sphincterotomy for Sphincter of Oddi Dysfunction Type III: the EPISOD Trial Revisited Paul Korc* 1, Hong Joo Kim 1,2, Chang-IL Kwon 1,3, James L. Watkins 1, Evan L. Fogel 1, Lee Mchenry 1, Stuart Sherman 1, Glen A. Lehman 1 1 Digestive and Liver Disorders, Indiana University Medical Center, Indianapolis, IN; 2 Internal Medcine, Sungkyunkwan University Kangbuk Samsung Hospital, Seoul, Korea (the Republic of); 3 Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea (the Republic of) Background: One year outcomes of the EPISOD trial for sphincter of Oddi dysfunction type III (SOD III) (Cotton PB, JAMA 2014) showed that ERCP with pancreatic and/or biliary sphincterotomy did not reduce disability due to pain compared to the sham group. However, the criteria for evaluating response were complex and may not reflect real world clinical assessments. Our institution enrolled 32 patients in EPISOD, approximately 10% of the SOD III patients who underwent ERCP with sphincter therapy over the same time frame. Thus, to evaluate response to therapy in the group of non-randomized patients not enrolled in EPISOD, we performed a retrospective cohort study. Aim: To determine the effectiveness of endoscopic sphincterotomy in pain relief for patients with SOD III. Methods: A total of 317 SOD III patients with manometrically proven SOD who underwent biliary and/or pancreatic sphincterotomy at Indiana University Hospital from August 2008 to March 2012 were identified. All patients met standard SOD III criteria of characteristic abdominal pain with normal labs and imaging. They were enrolled in alphabetical order in the retrospective cohort study. A simplified questionnaire including the severity (visual analog scale) and frequency (everyday or not) of pain, missing work/ activities or not, ED visits, and narcotic use was administered by a physician or nurse not involved in the patient s care. All interviews were conducted at least 1 year after initial ERCP. Results: Telephone interviews have been completed for 40 patients. At 1 year following ERCP, 29/40 (72.5%) maintained at least a 50% reduction in pain, and 13/40 (32.5%) remained 100% pain free. Twenty-five of 40 patients used narcotics for pain before ERCP. At 1 year, 14/25 (56%) remained free from narcotics, and 7/25 (28%) used less than half the prior dose. Thirty-one of 40 patients had at least 1 ED visit for abdominal pain prior to ERCP, and 22/31 (70.9%) did not require any ED visits in the year after ERCP. Conclusion: Based on our findings, ERCP with biliary and/or pancreatic sphincterotomy for manometrically proven SOD in Type III patients effectively reduces pain and narcotic requirements for at least 1 year in a majority of patients. Using the strictest criteria, 100% relief of pain or no narcotic use, 32.5% and 56% of the patients, respectively, achieved total success. Furthermore, 72.5% of the patients maintained at least a 50% reduction in pain at the 1 year mark. Despite being a retrospective cohort analysis, our study may be more reflective of real world clinical assessments of pain. These outcome data in general agree with multiple publications prior to Repeat sham-controlled, prospective, randomized trials using more applicable inclusion criteria, more realistic treatment success parameters, and longer term follow-up may be warranted. Mo1405 The Aberrant Shape of Main Pancreatic Duct Increases the Risk of the Post ERCP Pancreatitis Shintaro Kawasaki* 1, Juntaro Matsuzaki 2, Haruhiko Ogata 3, Eisuke Iwasaki 3, Takanori Kanai 1 1 Gastroenterology, Keio University school of medicine, Shinjuku, Japan; 2 Center for Preventive Medicine, Keio University Hospital, Tokyo, Japan; 3 Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan Background: Acute pancreatitis remains one of the most common complications of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post- ERCP pancreatitis (PEP) is still high: % after the diagnostic, and % after the therapeutic ERCP. It is important to know risk factors of PEP to minimize the incidence and the severity of PEP. The aim of this study is to investigate whether the pancreatic duct shape, evaluated by magnetic resonance cholangiopancreatography (MRCP), could be associated with the occurrence of PEP. Method: In this casecontrol study, we enrolled patients who underwent ERCP and showed high levels of serum amylase (O121 IU/l) after the procedure in our hospital between January 2012 and June We compared baseline clinical characteristics, including the pancreatic duct shape, and procedures between patients who developed PEP and those who did not. PEP was defined as elevated serum amylase levels of three times higher than the upper normal limit at 24 hours after ERCP, and having new or worsened abdominal or back pain. We categorized the shape of main pancreatic duct into three types as straight type, loop type, or reverse-z type using MRCP images before ERCP(fig1). Result: Among 1041 patients who underwent ERCP, 98 patients who showed elevated serum amylase levels by ERCP were extracted. After excluding 13 patients who did not undergo MRCP and 6 patients whose shape of pancreatic duct could not be categorized because of the poor MRCP images, 79 patients were analyzed. Among them, 16 patients (20.3%) developed PEP and 63 did not (79.7%). The presence of loop type pancreatic duct was not associated with PEP (6.3% in PEP group vs. 4.8% in non-pep group; pz0.60), whereas the presence of reverse-z type pancreatic duct was frequently observed in patients who developed PEP (31.3% vs. 9.5%; pz0.04)(fig2). Inter-observer agreement for the types of pancreatic duct was the kappa Z 0.764, which indicates substantial agreement. Univariate analyses also showed that non-past ERCP experience (28.0% vs 6.9%; pz0.04), non-past EST(27.5% vs 7.1%; pz0.04), bile duct biopsy (42.9% vs 15.4%; pz0.03), bile duct brushing cytology (46.2% vs 15.2%; pz0.02) and pancreatic acinar opacification (34.8% vs 14.3%; pz0.06) were risk factors for PEP. Multivariate logistic regression analysis revealed that the reverse-z type pancreatic duct (Odds Ratio [OR], 8.4; 95% confident interval [CI], ) and bile duct brushing cytology (OR, 10.5; 95% CI, ) were independent risk factors for PEP. Conclusion: The reverse-z type pancreatic duct, which could be diagnosed by MRCP before ERCP, was a possible risk factor for PEP. AB408 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
14 Figure 1. Trends of patients admitted with choledocholithiasis, with the number of ERCPs and proportion of ERCPs with pancreatic duct (PD) stent placement between 2003 and 2011, using the Nationwide Inpatient Sample Mo1406 Pancreatic Duct Stenting for the Prevention of Post-ERCP Pancreatitis: National Trends Mohammad H. Shakhatreh* 1, Somashekar G. Krishna 1, Jeffery R. Groce 1, Sheetal Sharma 1, Jon P. Walker 1, Alice Hinton 2, Samer El-Dika 1 1 Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, Columbus, OH; 2 Division of Biostatistics, School of Public Health, The Ohio State University, Columbus, OH Introduction: Studies have emerged to support the use of prophylactic pancreatic duct (PD) stent placement for the prevention of post-ercp pancreatitis. Patients with choledocholithiasis do not usually have a PD stent placed during ERCP unless it is for the sole purpose of preventing post-ercp pancreatitis. The aim of the present study was to evaluate the effect these studies have had on national trends in prophylactic PD stent placement. Methods: Using the Nationwide Inpatient Sample from 2003 to 2011, we retrospectively collected data on inpatients undergoing ERCP for choledocholithiasis. We analyzed the overall number of ERCPs and the number done when a PD stent was placed and evaluated the trend of utilization during the study period. We also evaluated the demographics and hospital characteristics for these patients. Results: During the study period, the number of admissions for choledocholithiasis increased from 112,675 (0.29% of all admissions) in 2003 to 149,271 (0.39% of all admissions) in 2011 (p!0.0001) (Figure 1). There was a decrease in the proportion of inpatient ERCPs among patients admitted with choledocholithiasis from 67.0% in 2003 to 62.8% in 2007, but then this gradually increased to 65.6% in 2011 (Figure 1). During the same study period, an increase in the use of pancreatic duct stenting was noted, starting in 2005 and peaking at 3.6% in 2010 (Figure 1). The mean age of patients who underwent ERCP with PD stent placement was 56.8 years (95%CI ). Most PD stents were placed in women (64.8%) and in Whites (68.8%). The use of PD stents was more common in urban teaching hospitals (51.8%) and large size hospitals (67.5%). Most patients who underwent placement of a PD stent had an Elixhauser comorbidity index of less than 3 (64.2%). Conclusion: Despite the decline in the proportion of inpatient ERCPs among patients admitted with choledocholithiasis between 2003 and 2011, the use of PD stenting has significantly increased, especially since 2005, after multiple studies were published reporting decreased rates of post-ercp pancreatitis with the use of prophylactic PD stents. Mo1407 Post ERCP Complications: Comparing Standard Biliary Cannulation With Needle Knife Fistulotomy Gul Nisar 2, Hamama-Tul-Bushra Khaar 2, Muhammad Umar 2, Tayyab S. Akhter 2, Muhammad Khurram 2, Mohammad Bilal* 1, Shifa Umar 3 1 Internal Medicine, Allegheny General Hospital, Pittsburgh, PA; 2 Center of Liver and Digestive Diseases, Holy Family Hospital, Rawalpindi, Pakistan; 3 Shifa College of Medicine, Islamabad, Pakistan Background and Aims: Needle knife fistulotomy (NKF) is becoming increasingly popular in cases where standard biliary cannulation (SBC) cannot be achieved, however, controversies remain regarding the safety concerns of this procedure. Our study aims to compare the frequency of complications amongst SBC and NKF. Methods: Patients who underwent ERCP between April, 23, 2014 and November, 23, 2014 were eligible for this study. Data were collected and analyzed for 200 patients. Patients who underwent ERCP between April, 23, 2014 and November, 23, 2014 were eligible for this study. Data were collected and analyzed for 200 patients. A retrospective cross sectional study was carried out to assess for post ERCP complications and comparison was made amongst patients who underwent SBC (Group I) and those who underwent NKF (Group II). Results: Group I included 110 patients whereas group II had 90 patients. The complications observed in all 200 patients were post ERCP pancreatitis (5%), hemorrhage (2%), CBD perforation (0.5%), cholangitis (1.5%), hypoxia (2%), and respiratory distress (1%). The risk of development of respiratory distress (Relative riskz1.83, 95% Confidence interval ), hemorrhage (RRZ1.83, 95% CI ), post ERCP pancreatitis (RRZ1.09, 95% CI ), and cholangitis(rrz1.84, 95% CI ) was observed to be higher in Group I, whereas the risk for CBD perforation (RRZ2.23, 95% CI ) and Hypoxia(RRZ2.25, 95% CI ) was higher in Group II. Conclusion: NKF is safer than SBC in terms of respiratory distress, post ERCP pancreatitis, hemorrhage and cholangitis, while the risk of CBD perforation and hypoxia is increased with NKF. Mo1408 Prophylaxis of Post-ERCP Pancreatitis Using Temporary Pancreatic Stent vs Rectal Nonsteroidal Anti-Inflammatory Drug: a Randomized Controlled Trial Tatsuya Koshitani*, Masataka Masuda, Kou Fujiwara, Keimei Nakano, Shuichi Fuki Department of Gastroenterology, Kobe Central Hospital, Kobe, Japan Background: Placement of pancreatic stents prevents post-ercp pancreatitis (PEP). There is evidence that rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) also prevents PEP, but the 2 approaches alone have not been compared directly. The aim of this study was to compare the efficacies of these procedures to prevent PEP in Japanese populations. Methods: Thirty six patients undergoing ERCP mainly for the therapy of common bile duct stones were studied. The study group included the patients at high risk for PEP because of a difficult cannulation, precut sphincterotomy, and/or pancreatic duct injection. Each patient was randomly allocated to receive pancreatic stent placement (nz12), administration of 50 mg diclofenac (nz12), or both (nz12) to prevent PEP. The stent used was a 5F, 3-cm long pancreatic stent without an inner flange, which was dislodged spontaneously. The diclofenac was administered rectally immediately after ERCP. The primary Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB409
15 endpoint of this study was the frequency of PEP, and the secondary outcome included mean serum amylase level after the procedures in each treatment group. Results: Pancreatic stents were placed successfully in 88% of the cases (21/24). One patient developed mild PEP, who was administered 50 mg diclofenac. There were no significant differences in the frequency of PEP and mean serum amylase level after the procedures among the three groups. Conclusion: The rectal administration of 50 mg diclofenac may be effective to prevent PEP in Japanese populations when the pancreatic stent placement fails. However, further accumulation of the cases is needed in order to make a clear conclusion. Mo1409 The Effect of Pancreatic Sphincterotomy on the Prevention of Pancreatitis During ERCP Comparing With Pancreatic Stent; a Preliminary Report of a Prospective Randomized Trial Jinwoo Choi* 1, Chang-Min Cho 1, Min Kyu Jung 1, Jun Heo 1, Gab Chul Kim 2 1 Internal Medicine, Kyungpook National University Hospital, Daegu, Korea (the Republic of); 2 Radiology, Kyungpook National University Medical Center, Daegu, Korea (the Republic of) Background and Aims: Pancreatitis is the most frequent and distressing complication of endoscopic retrograde cholangiopancreatography (ERCP). Independent patientand procedure-related risk factors for post-ercp pancreatitis (PEP) have been previously disclosed. The acinar injury caused by impaired drainage of the pancreatic duct is a commonly accepted mechanism of PEP. Many previous studies have accepted the pancreatic sphincterotomy as a risk factor of PEP. We hypothesized that pancreatic sphincterotomy would improve the flow of pancreatic duct and could prevent PEP in cases of difficult cannulation. Patients and Methods: As a prospective randomized study, all consecutive patients who need ERCP examination were enrolled by excluding any case of the following; active pancreatitis at the time of ERCP, evidence of chronic pancreatitis, previous history of sphincterotomy, cardiopulmonary instability unable to receive conscious sedation, or uncorrectable coagulopathy. When a difficult cannulation was occurred during ERCP, patients were randomly allocated into endoscopic pancreatic sphincterotomy (EPS group) and additional insertion of pancreatic stent (Stent group). The difficult cannulation was defined as one of the following: cannulation attempts of more than 10 times before selective cannulation, contrast injection into pancreatic duct after 5 or more times of cannulation attempt, and precut incision after 5 or more times of cannulation attempt. After ERCP, we checked presence of abdominal pain, serum amylase and lipase at 6, 24, and 48 hours after ERCP. The incidence and severity of PEP were compared between two groups. PEP was diagnosed according to modified Cotton s criteria. Results: From Sep to Nov. 2014, total of 246 patients (median age 69 year; 142 males) underwent ERCP. Easy cannulation was accomplished in 201 patients (81.7%) and difficult cannulation in 45 (18.3%). Among patients with difficult cannulation, simple pancreatic sphincterotomy was applied in 23 and additional insertion of pancreatic stent in 22 patients. Technical failure was occurred in each 2 case of both groups. There were no significant differences between EPS and Stent groups with respect to age (72 vs. 69), gender (male:female, 7:14 vs. 13:7), mean procedure time (30.3 min vs min) and purpose of ERCP intervention. PEP was occurred in 8 patients (38.1%) of EPS group and 5 (25.0%) of Stent group. The severity of pancreatitis was mild in 6 (28.6%) of EPS and 4 (20.0%) of Stent group and moderate in 2 (9.5%) and one (5.0%), respectively. There was no statistical difference in the incidence of PEP (pz0.505) and the rate of hyperamylasemia (pz0.724) between two groups. Conclusions: For the prevention of PEP, prophylactic EPS might be approved as a safe and effective technique compared with stent insertion. However, further study is needed including more cases. Table 1. The incidence of PEP among easy cannulation group, EPS group and Stent group Difficult cannulation Severity of PEP Easy cannulation (n[201) EPS (n[21) EPS+Stent (n[20) p value Overall 25 (12.5%) 8 (38.1%) 5 (25.0%) Mild 20 (10.0%) 6 (28.6%) 4 (20.0%) Moderate 4 (2.0%) 2 (9.5%) 1 (5.0%) Severe 1 (0.5%) 0 0 PEP, postercp pancreatitis; p value, EPS vs. EPS+Stent Mo1410 Medical Risk Factors for Inpatient Post-ERCP Pancreatitis: a Nationwide Analysis Allison R. Schulman* 1, Marwan Abou Gergi 2, Marvin Ryou 1, Violeta Popov 3, Julia Mcnabb-Baltar 1, Christopher C. Thompson 1 1 Division of Gastroenterology, Brigham & Women, Boston, MA; 2 Catalyst Medical Consulting, Towson, MD; 3 Medicine, NYU School of Medicine, New York, NY Introduction: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is a well-known and insidious complication associated with ERCP. Precise identification of risk factors for developing this complication is important in order to improve the procedural safety and acknowledge high-risk individuals in whom protective measures should be considered. Aims: To identify patient-related risk factors for the development of pancreatitis following inpatient ERCP. Methods: This was a retrospective cohort study using the 2012 Nationwide Inpatient Sample (NIS) database. NIS is nationally representative and contained information from 39 million discharges from 1050 hospitals across 44 states in Discharges with an ICD-9 CM procedure code indicating ERCP and a secondary ICD-9 CM code for acute pancreatitis were included. Patients were excluded if a principal diagnosis of acute pancreatitis or an ERCP was performed before or on the day of admission. The primary outcome was incidence of post-ercp pancreatitis. Variables tested to identify independent predictors of post-ercp pancreatitis included alcohol, smoking, hypertension, hypothyroidism, diabetes, congestive heart failure, liver disease, peripheral vascular disease, coagulopathy, cancer, obesity, number of comorbidities, renal failure, leukemia/lymphoma, age, female, renal failure, stroke, hypertriglyceridemia, HIV/AIDS, and chronic obstructive pulmonary disease. Each variable was tested first for association with post ERCP pancreatitis using a univariable logistic regression model. A stepwise forward selection model was then used to build the multivariate logistic regression model. A p-value of 0.05 was considered significant. Results: A total of 23,870 patients met inclusion criteria. Of these, 3,275 (13.72%) developed post-ercp pancreatitis. Significant medical risk factors from the univariate and multivariate logistic regression models are shown in Table 1. From the univariate analysis, diabetes, cancer, obesity, number of co-morbidities and age were all found to be significant predictors for developing post-ercp pancreatitis. From the final model obtained using multivariate regression analyses, obesity and age were significant risk factors, while patients with cancer had lower rates of post-ercp pancreatitis. Conclusions: Obesity and age were all found to be significant predictors of the development of pancreatitis following ERCP in the inpatient setting. Unlike other smaller studies, female gender did not reach statistical significance. Table 1. Medical risk factors for developing post-ercp pancreatitis based on a univariable logistic regression model Risk Factors Univariable Logistic Regession Adjusted OR [95% CI] p-value Multivariable Logistic Regression Adjusted OR [95% CI] p-value Diabetes 0.82 [0.68, 0.99] 0.045* NS NS Cancer 0.31 [0.21, 0.46]!0.001* 0.34 [0.23, 0.50]!0.001* Obesity (BMI R 30) 1.57 [1.27, 1.96]!0.001* 1.43 [1.15, 1.78] 0.002* Number of co-morbidities 0.96 [0.93, 0.98] 0.001* NS NS Age 0.99 [0.98, 0.99]!0.001* 0.99 [0.99, 0.99] 0.001* 95% C.I. Z 95% confidence interval. *denotes p-value!0.05, NS denotes non-significance. Mo1411 Aggressive Lactated Ringer s Solution for Prevention of Post ERCP Pancreatitis (Preliminary Data of a Prospective Randomized Trial) Palita Chuankrerkkul* Phramongkutklao hospital, Bangkok, Thailand Background: Pancreatitis is serious complication of endoscopic retrograde cholangiopancreatography (ERCP). Pilot study suggested that aggressive intravenous hydration with lactated Ringer s solution appeared to reduce the development of post ERCP pancreatitis. Objective: To evaluate effect of aggressive hydration with lactated Ringer s solution on the frequency and severity of post ERCP pancreatitis in patient without previous sphincterotomy. Methods: We performed a randomized doubleblind prospective study. Patients who were scheduled to undergo ERCP were randomized to receive lactated Ringer s solution either aggressive hydration group (3 ml/kg/hr during ERCP, 10 ml/kg bolus and 3 ml/kg/hr for 8 hr after ERCP) or normal hydration group (1.5 ml/kg/hr during ERCP and 8 hour after ERCP). All patients were evaluated for pancreatic pain, level of serum amylase, lipase, C-reactive protein, frequency of pancreatitis, and clinical of volume overload. Standardized criteria were used to diagnose and grade the severity of post ERCP pancreatitis. Results: To date, sixty patients (mean age 61.9 years) were enrolled and randomized. Two patients (6.7%) in normal hydration group and three patients (10%) in aggressive hydration group developed post ERCP pancreatitis which was not significantly different (pz1.000). Two patients in normal hydration group were graded in mild severity. Three patients in aggressive hydration group were graded in moderate severity. None of the patients in this preliminary data was graded in severe post ERCP pancreatitis. C-reactive protein was similar between groups (meansd was and mg/dl in normal hydration group and aggressive hydration group respectively, pz0.80). Two groups were similar with regard to age, gender, body mass index, frequency of previous pancreatitis, indication for ERCP, difficulty of cannulation, frequency of precut sphincterotomy. None of the patients in this study developed fluid overload. Conclusion: This preliminary result shows that aggressive lactated Ringer s solution during and after ERCP did not reduce the frequency of post ERCP pancreatitis. There was a trend toward increase severity of post ERCP pancreatitis in aggressive hydration group. AB410 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
16 Frequency of post ERCP pancreatitis in both groups Number of patient (%) Normal hydration Aggressive hydration P-value No PEP* 28 (93.3%) 27 (90%) Mild PEP* 2 (6.7%) 0 (0%) Moderate PEP* 0 (0%) 3 (10%) Severe PEP* 0 (0%) 0 (0%) All case PEP* 2 (6.7%) 3 (10%) *PEP Post ERCP Pancreatitis Mo1412 Comparison Between Ulinastatin and Nafamostat Mesylate for the Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis Yoshiaki Kawaguchi*, Tetsuya Mine Tokai University School of Medicine, Isehara, Japan Background: It has been reported that the administration of ulinastatin, gabexate mesylate, nafamostat mesylate, NSAID, or somatostatin may be effective in the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, a few trials of ulinastatin and nafamostat mesylate for the prevention of post-ercp pancreatitis have been reported. The aim of this study was to compare the efficacy of ulinastatin and nafamostat mesylate for the prevention of post-ercp pancreatitis. Methods: One thousand patients who underwent diagnostic and therapeutic ERCP at our hospital were divided into an ulinastatin group (n Z 500) and a nafamostat group (n Z 500). Each patient received a continuous intravenous infusion of ulinastatin (150,000 units) or nafamostat mesylate (20 mg), beginning about 60 min before the ERCP and continuing until 24 h after the ERCP. We compared the incidence of post-ercp pancreatitis, hyperamylasemia, pain and side effect. Results: Both groups were comparable in baseline characteristics. The overall incidence of post-ercp pancreatitis was 2.5% (twenty-five patients), comprising twelve patients in the ulinastatin group and thirteen patients in the nafamostat group (2.4% vs 2.6%, respectively). Neither of these patients developed severe pancreatitis. There were no significant differences in the serum levels of amylase or in the levels of pain between the two groups. None of the patients suffered any adverse effects related to ulinastatin or nafamostat mesylate administration. Conclusions: There was no clinical difference between the effect of preventive administration of ulinastatin and that of nafamostat mesylate on the incidence of post-ercp pancreatitis. It would be desirable in the future to conduct further studies to determine the optimal dose and timing of the administration of ulinastatin and nafamostat for the prevention of post-ercp pancreatitis. valuable predictive marker for PEP. This marker could help to prevent the development of PEP early after ERCP. Mo1414 Novel Risk Factors for Post - ERCP Bacteremia Liat Mlynarsky* 1,2, Adam Phillips 1,2, Alaa Melhem 1,2, Erwin Santo 1,2 1 Department of Gastroenterology, Tel Aviv Medical Center, Tel-Aviv, Israel; 2 Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel Background & Aim: According to ASGE recommendations antibiotic prophylaxis is not recommended when an ERCP is likely to achieve complete biliary drainage. However, clinically significant post-ercp bacteremia (PEB) occurs in up to 5% of cases and other risk factors are not fully established. The aim of this study was to evaluate possible risk factors for PEB in patients who were not administered antibiotics prior to ERCP. Methods: This is a retrospective cohort study characterizing 1,047 consecutive patients who underwent ERCP in the Tel-Aviv Medical Center between January December 2013, assessing attributes of PEB. Exclusion: a) positive bacterial culture before ERCP, b) any antibiotic treatment prior to ERCP procedure, c) hospitalization longer than 14 days before ERCP. Risk factors for bacteremia were assessed by stepwise logistic regression. Results: A total of 486 procedures were included, 41.8% males, mean age years. Post procedural bacterial blood cultures were drawn in 14.2% of ERCPs with a mean interval of days (range 0-13 days, median 2 days). Positive cultures were documented in 4.9% of ERCPs. Age and ERCP duration were comparable between PEB and non- PEB groups. Patients older than 75 year had significantly higher prevalence of PEB (7.7% vs. 3.5%, PZ0.038). The indication with the highest rate of PEB was first intervention in an obstructive malignancy (9.3%), followed by choledocholithiasis (4.2%). Other indications included: elective stent replacement (3.9%) and benign bile duct stricture (3.6%). PEB was significantly more prevalent among tandem endoscopic ultrasound (EUS) and ERCP procedures compared to ERCP only (12.2% vs. 4.3%, PZ0.025, respectively). Patients with native papilla had a significantly higher prevalence of PEB in comparison with experienced patients (7.3% vs. 3.0% PZ0.028, respectively). TTS dilatation was utilized in 24/486 ERCPs, none resulted in PEB. There were no PEBs (0%) when metal stent was placed. Nevertheless, higher rates of PEB were not observed among type of stent comparison (plastic vs. metal) nor in biliary or pancreatic stent placement or presence of previous stent (PZNS). In a multivariate analysis three risk factors achieved statistical significance: tandem EUS-ERCP (OR 3.3, 95%CI: ), age O75 years (OR 2.7, 95%CI: ) and first intervention in an obstructive malignancy (OR 2.5, 95%CI: ). Conclusions: Tandem EUS - ERCP, age above 75 years and first intervention in an obstructive malignancy were found to be significant risk factors for PEB. These factors should be further studied as indications for prophylactic antibiotic treatment. Mo1413 Post-Endoscopic Retrograde Cholangiopancreatography 2-Hour Amylase Level Is a Useful Predictor of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis Shiro Hayashi*, Tsutomu Nishida, Takahiro Amano, Aisa Sakamoto, Yuriko Otake, Wataru Takagi, Hirotsugu Saiki, Hisashi Kondo, Makiko Urabe, Kei Takahashi, Tokuhiro Matsubara, Masashi Yamamoto, Sachiko Nakajima, Koji Fukui, Masami Inada Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Japan Background: Acute pancreatitis is common complication after endoscopic retrograde cholangiopancreatography (ERCP) and called post-ercp pancreatitis (PEP). It is sometimes potentially leading to procedure-related death, and however, difficult to completely prevent. Therefore, it is important to predict PEP to permit early intervention. Serum amylase level after ERCP-related procedure including 3-hour or 4-hour amylase levels is previously reported as a predictor of PEP, however, 2-hour amylase levels is still unclear. Aim: This study aimed to estimate the efficacy of post- ERCP 2-hour serum amylase levels for predicting post-ercp pancreatitis (PEP). Material and Method: The study was a retrospective single center cohort study of consecutive patients that underwent ERCP from January 2010 to December Serum amylase levels (upper limit 120 IU/L) were measured 2 hours after the procedure. Receiver operating characteristic analysis was used to evaluate the ability of 2-hour amylase levels to predict PEP. The patient-related and procedure-related risk factors of PEP were analyzed using a logistic model. Result: A total of 1520 patients (average age 7212, men 60%) were enrolled. Of them, 117 cases with the following conditions were excluded: 1) gallstone pancreatitis, 2) unreachable to papilla, 3) missing data of procedure time or serum amylase levels. Finally, 1403 cases were analyzed. The 2-hour amylase cut-off value for PEP was 264 IU/L (AUC: 0.93). Patients with an amylase level greater than 264 IU/L (46/211, 21.8%) had a significantly higher rate of PEP than those with a lower amylase level (9/1192, 0.8%). Univariate analysis revealed 10 significant predictive factors for PEP: female sex, native papilla, cannulation time, total procedure time, endoscopic biliary stent, precut, endoscopic sphincterotomy, endoscopic papillary balloon dilation, pancreatic duct brush cytology, and 2-hour amylase level. Multivariate analysis of these factors revealed that cannulation time longer than 13 min [OR 2.1, 95% CI ] and 2-hour amylase level [OR 24.3, 95% CI ] were significant predictive factors for PEP. Conclusion: These findings indicate that post ERCP 2-hour serum amylase level is a Mo1415 Incidence and Outcomes of Post-ERCP Pancreatitis During the Academic Year: Is July Dangerous? Allison R. Schulman* 1, Marwan Abou Gergi 2, Marvin Ryou 1, Christopher C. Thompson 1 1 Division of Gastroenterology, Brigham & Women, Boston, MA; 2 Catalyst Medical Consulting, Towson, MD Introduction: The changeover of medical trainees at the beginning of the academic year has been shown in a variety of subspecialties to negatively impact the quality of patient care. At academic institutions, endoscopic retrograde cholangiopancreatography (ERCP) involves advanced endoscopy fellows. This procedure carries a risk of pancreatitis, and outcomes may vary based on the time of year it is performed. Aims: To assess incidence of post-ercp pancreatitis in the early (July/August/September) versus the late (April/May/June) academic year. Secondary aims evaluate in-hospital mortality, length of stay (LOS), and total hospitalization charge between these time periods. Methods: This was a retrospective cohort study using the 2012 Nationwide Inpatient Sample (NIS), a nationally representative database of inpatient admissions. Patients with ICD-9 CM procedure codes for ERCP were included in the study. Patients were excluded if they had a principal diagnosis of acute pancreatitis or if the ERCP was performed before or on the day of admission. Post-ERCP pancreatitis was defined as an ICD-9 CM code for a secondary diagnosis of acute pancreatitis. ERCPs performed during the months of July, August and September were compared to those performed in April, May and June both in academic and non-academic hospitals. The primary outcome was incidence of post-ercp pancreatitis. Secondary outcomes included in-hospital mortality, length of stay (LOS), and total hospitalization charge. Crude and adjusted odds ratios were calculated using univariable and multivariable regression analyses. Proportions were compared using fisher s exact test and continuous variables using the student t-test. Results: A total of 11,553 cases were analyzed (5,642 in July/August/September and 5,911 in April/May/June) in the 2012 academic year. Incidence of post-ercp pancreatitis in early versus late academic year were not statistically significant (OR 1.03, 95% CI [ ]; pz0.415). Similarly, the adjusted odds ratio of mortality in early compared to late academic year were not statistically significant. In patients who developed post-ercp pancreatitis, adjusted odds ratio between early and late academic year for LOS (2.04 vs. 0.34, p!0.01) and total hospitalization charge ($20,990 vs. $4,861, p!0.01) were Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB411
17 statistically significant. Conclusions: Incidence of post-ercp pancreatitis does not differ at academic institutions depending on the time of year. However, LOS and total hospital charge do decrease throughout the academic year, suggesting the existence of a temporal effect. These differences may be explained by the influx of new medical trainees, on whom teaching hospitals depend for the bulk of their staffing, and further investigation is warranted. Mo1416 Outcomes of Post-ERCP Pancreatitis Have Not Improved Over the Past Decade Allison R. Schulman* 1, Marwan Abou Gergi 2, Marvin Ryou 1, Christopher C. Thompson 1 1 Division of Gastroenterology, Brigham & Women, Boston, MA; 2 Catalyst Medical Consulting, Towson, MD Introduction: Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Over the past several years, routine use of rectally administered nonsteroidal anti-inflammatory drugs (NSAIDs) and prophylactic pancreatic stent placement in high risk patients have been utilized in an attempt to mitigate this complication. Aims: To compare outcomes of post-ercp pancreatitis over the past decade ( ) including overall incidence, mortality, intensive care unit (ICU) transfer rate, length of stay (LOS) and attributable total charge. Methods: The Nationwide Inpatient Sample (NIS) database was used to calculate outcomes in 2012, 2010, 2007, 2004 and Discharges with an ICD-9 CM procedure code indicating ERCP and a secondary ICD-9 CM code for acute pancreatitis were included. Patients were excluded if they had a principal diagnosis of acute pancreatitis or if the ERCP was performed before or on the day of admission. The primary outcome was incidence of post-ercp pancreatitis. Secondary outcomes were in hospital mortality, ICU transfer rate, additional LOS and attributable total charge. All charges were adjusted for inflation using the consumer price index. Total disease burden was calculated by multiplying the total number of patients by the mean attributable total charge per hospitalization. LOS and charge were adjusted for the following potential confounders using a multivariable regression model: age, sex, race, median income in the patient s zip code, number of comorbidities, hospital location (rural vs. urban), region (Northeast, Midwest, West, or South), teaching status, and size. Fisher s exact test and Student t-test were used to compared proportions and continuous variables, respectively. Results: A total of 119,006 patients underwent inpatient ERCP in 2012, 2010, 2007, 2004, and 2002, 14,772 of whom developed post-ercp pancreatitis leading to a cumulative incidence of 12.4%. Incidence of post-ercp pancreatitis by year is shown in Table 1. The mortality rate, ICU transfer rate, and LOS do not show a particular trend over the past decade, and the disease burden ranges from over $7.6 million in 2004 to over $52.7 million in 2010 (Table 1). Conclusions: The incidence of post-ercp pancreatitis appears to be increasing over the past decade, despite the routine use of NSAIDs and prophylactic pancreatic stent placement. The ICU transfer rate, LOS, and mortality have similarly not improved over this time period. Table 1. Post-ERCP pancreatitis outcome trends between 2002 and Incidence (per 100,000 persons) Inpatient mortality (%) ICU transfer rate (%) Median LOS, days [95% C.I.] 1.08 [0.59, 1.57] 1.19 [0.10,2.28] 1.50 [0.68, 2.31] 2.01 [1.35, 2.84] 1.44 [0.64, 2.23] Consumer price index adjusted median total charge [95% C.I.] Consumer price index adjusted economic burden in million U.S. dollars 95% C.I. Z 95% confidence interval 15,953 [8,125, 23,78] 13,875 [199, 27,951] 14,142 [5,651, 22,633] 27,104 [17,478, 36,730] 19,648 [8,631, 30,654] Mo1417 Usefulness of Co 2 Enterography During Double-Balloon Enteroscopy Assisted Endoscopic Retrograde Cholangiopancreatography Ichiro Moriyama* 1, Nobuhiko Fukuba 2, Hiroki Sonoyama 2, Yasumasa Tada 2, Akihiko Oka 2, Tsuyoshi Mishiro 2, Naoki Oshima 2, Hiroshi Tobita 2, Takafumi Yuki 3, Kousaku Kawashima 2, Tatsuya Miyake 2, Norihisa Ishimura 2, Shuichi Sato 3, Shunji Ishihara 2, Yoshikazu Kinoshita 2 1 Cancer Center, Shimane University, Izumo, Japan; 2 Gastroenterology, Shimane University Faculty of Medicine, Izumo, Japan; 3 Division of Gastrointestinal Endoscopy, Shimane University Hospital, Izumo, Japan Background and Aim: Double-balloon enteroscopy assisted endoscopic retrograde cholangiopancreatography (DB-ERCP) techniques allow endoscopic treatment of pancreatobiliary disease in patients with surgically altered upper gastrointestinal anatomy. However, it is still difficult for the scope to reach the papilla of Vater or bilioenteric anastomosis due to the maze-like gastrointestinal tract after surgery. We have used a negative contrast technique with carbon dioxide (CO 2 )inflation, termed CO 2 enterography, during DB-ERCP since September This study aimed to evaluate the safety and efficacy of CO 2 enterography in patients with altered upper gastrointestinal anatomy. Methods: We retrospectively reviewed 64 DB-ERCP cases with surgically altered upper gastrointestinal tract anatomy at Shimane University Hospital between February 2009 and September The cases were divided into the CO 2 enterography group (nz48) and a control group (nz16) without CO 2 enterography during DB-ERCP, conducted between February 2009 and August Cases with Billroth I reconstruction were excluded. Arrival ratio to target site, average time to target site arrival, and adverse events were evaluated and compared between the groups. CO 2 monitoring was performed during the procedure in all cases. Results: Surgical treatments of enrolled cases were as follows; pancreaticoduodenectomy (PD) (nz8), Roux-en Y total gastrectomy (RY) (nz7), and Billroth II gastrectomy (B-II) (nz1) in the control group, PD (nz12), R-Y (nz20), B-II (n Z 13), and others (nz3) in the CO 2 enterography group. The arrival ratio was 100% (16/16) in the control and 83.3% (40/48) in the CO 2 enterography group. The average time was significantly shorter in the latter (24 vs. 38 min, PZ0.011). As for major adverse events, perforation occurred in two CO 2 enterography cases (4.2%). However, adverse events were not associated with CO 2 inflation but, rather, with excessive pushing of the scope during BE-ERCP. No cases had hypercapnia during the procedure. Conclusion: We found that CO 2 enterography during DB-ERCP was safe and useful for shortening the procedure time for confirmation of the correct tract, avoiding wasted efforts due to incorrect tract insertion. We thus consider this technique to be useful for insertion in DB-ERCP cases. Mo1418 A Multicenter Retrospective Review of Approach and Outcomes of Patients With Post-Surgical Anatomy Undergoing ERCP Alexander Browne* 1, Sumit Kapoor 2, Ayanna E. Lewis 3, Jawad Ahmad 4, Jonathan Buscaglia 2, Satish Nagula 2, Christopher J. Dimaio 5, Juan Carlos Bucobo 2, Susana Gonzalez 5 1 Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY; 2 Division of Gastroenterology and Hepatology, Stony Brook University School of Medicine, Stony Brook, NY; 3 Department of Medicine, Stony Brook University School of Medicine, Stony Brook, NY; 4 Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY; 5 Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY Objective: Retrospective review of ERCPs performed in patients with surgically altered pancreaticobiliary anatomy to review endoscopic approaches to the procedures and to determine factors predictive of endoscopic and therapeutic success. Methods: Retrospective review of all patients with surgically altered upper gastrointestinal anatomy that underwent diagnostic and/or therapeutic ERCP between August 2009 and September Data regarding type of surgical anatomy, procedure indication, the type of endoscope used, success in reaching the papilla, ability to interrogate the desired ductal system, performance of diagnostic and/or therapeutic maneuvers was collected. Results: 104 ERCPs were performed in 70 patients with surgically altered anatomy (37 female, 33 males, mean age 63, range yrs). Of the104 ERCPs, the anatomy was: Whipple (nz73), Roux-en-Y Hepaticojejunostomy (nz12), Roux-en-Y Gastric Bypass (nz13), and Billroth II (nz6). Most common indications for ERCP were abnormal LFTs (nz28), abnormal imaging (nz25) and choledocholithiasis (nz13). Endoscopic success, defined as accessing the papilla or the biliary enteric anastomosis, occurred in 74/104 ERCPs (71.1%). ERCP success, defined as completion of the intended therapeutic intervention, occurred in 69/104 ERCPs (66%). 73 ERCPs done on patients with Whipple anatomy, had a 65% ERCP therapeutic success rate using a pediatric colonoscope, a 40% success rate using a Spirus enteroscope. 12 ERCPs on patients with a Roux-en-Y Hepaticojejunostomy had 100% ERCP success rate using a pediatric colonoscope, 67% success rate using a single balloon enteroscope, and 50% success rate using a Spirus enteroscope. ERCPs on Roux-en-Y Gastric Bypass patients had a 0% ERCP success rate with a single balloon enteroscope and a 45% success rate with the Spirus enteroscope. 6 ERCPs were done on patients with a Billroth II, with an 83% ERCP success rate using a duodenoscope. Reasons for ERCP failures (nz35) included inability to reach papilla (nz 25), inability to cannulate (nz7), inability to place a stent (nz2) and failure to remove stones (nz1). There were 3 complications (2.8%): aspiration pneumonia, a perforated afferent limb, and de-saturation during the ERCP. Conclusions: ERCP is a technically feasible modality to address potential pancreaticobiliary pathology in patients with surgically altered pancreaticobiliary anatomy. We had an overall endoscopic success rate of 71.1% and an overall ERCP success rate of 66% with a complication rate of 2.8% in our cohort. The lowest therapeutic success rates were in RYGB patients likely due to the challenging nature of navigating a long surgical limb and then cannulating a native papilla. Other long limb anatomies such as Roux-en-Y hepaticojejunostomy and Whipple anatomy had higher therapeutic success rates without the need of an overtube based enteroscope. AB412 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
18 Mo1419 Prevention of Recurrence of Fluid Collections in Walled Off Pancreatic Necrosis and Disconnected Pancreatic Duct Syndrome: Comparative Study of One Versus Two Long Term Transmural Stents Surinder S. Rana*, Ravi Sharma, Rajesh Gupta, Deepak K. Bhasin Post Graduate Institute of Medical Education & Research, Chandigarh, India Introduction: Disconnected pancreatic duct syndrome (DPDS) can occur in up to 50% of patients with walled off pancreatic necrosis (WOPN). To prevent recurrences of pancreatic fluid collections (PFC s) in these patients, placement of long term indwelling transmural stents has been shown to be an effective and safe strategy. As stents get blocked over a period of time, it has been suggested that instead of a single stent, placement of multiple stents would be a better strategy as the pancreatic secretions can continue to drain in between the stents. Aim: To retrospectively evaluate the safety and efficacy of one versus two long term transmural stents in patients with successfully treated walled off pancreatic necrosis and disconnected pancreatic duct syndrome. Methods: The records of consecutive patients who underwent endoscopic transmural drainage of WOPN over last three years were analyzed. The patients with WOPN and DPDS having one or two long term transmural stents were identified and included and patients with a partial pancreatic duct (PD) disruption and bridging transpapillary stent or normal PD were excluded. The patients regularly followed up in the clinic or were contacted telephonically three monthly for any symptoms or hospitalization. In symptomatic patients, cross sectional imaging was done to identify recurrence of PFC. Results: Thirty nine patients (31M; mean age: years) with one or two permanent indwelling transmural stents and DPDS were followed up for a mean of months (range: 2-56 months).the etiology of acute necrotizing pancreatitis was alcohol in 25, gall stones in 10 and idiopathic in 4 patients. Twenty four patients had two 7 Fr (18) or 10 Fr (6) long term stents whereas a single stent was placed in 15 patients (10 Fr in 13 and 7Fr in 2 patients). In two stent group, spontaneous stent migration was observed in 6 (25%) patients with both 7Fr stents migrating in 5 patients and one 10Fr stent migrating in one patient whereas stent migration was observed in 3 (21%) patients in single stent group (10Fr in two and 7Fr in 1 patient). Stent migration led to recurrence of pancreatic fluid collection (PFC) in one patient in each group whereas in the remaining patients it did not cause any symptoms and were detected by the patients in the stools. In the patients with intact long term transmural stents, there was no recurrence of symptoms or PFC in both the groups. One of the patients with recurrent PFC required surgery whereas the other was managed conservatively. Conclusion: Single stent is as efficacious as two long term transmural stents in preventing recurrence of PFC in patients of WOPN and DPDS successfully treated by endoscopic drainage. Stent migration occurred in significant proportion of patients in both the groups and some of these patients with migrated stents had PFC recurrence. Mo1420 Multiple Plastic Pigtail Stent Method for the Endoscopic Treatment of Walled Off Pancreatic Necrosis Sarah M. Hyder*, Stuart R. Gordon, Kartik Sampath, Timothy B. Gardner Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH Background & Aims: Walled off pancreatic necrosis (WOPN) is increasingly being treated via direct endoscopic necrosectomy; however the number and type of stents to place following cystenterostomy is controversial. We compared the one and done technique of placing multiple plastic pigtail stents at the time of first endoscopy vs. the standard multiple debridement technique for important clinical outcomes. Methods: We evaluated all patients at our center who underwent direct endoscopic necrosectomy for WOPN. Patients were stratified into whether they received maximum cystenterostomy dilation and more than three plastic stents at initial endoscopy ( one and done group) vs. patients who had multiple debridement sessions and less than three stents placed ( standard group). Stents were not removed endoscopically in the one and done group. Patients were excluded who had metallic stent placement or did not have at least 10% solid debris within the collection. The primary clinical outcome was cavity resolution and a multivariable regression model was built to adjust for potentially important confounders. Results: 36 patients met inclusion criteria and the baseline characteristics of each group are demonstrated in table 1. Patients in the one and done group had a faster time to cavity resolution (1.7 vs 3.0 months, pz0.04) and a trend toward less overall endoscopic procedures (1.2 vs 2.4) and a higher likelihood of cavity resolution. The lack of statistical significance is likely due to Type II error. Multivariable regression for cavity resolution did not reveal any factors which significantly contributed to cavity resolution. Conclusion: In patients undergoing successful cystenterostomy for WOPN, the one and done technique leads to faster cavity resolution and likely less overall number of endoscopic procedures. Baseline Patient Characteristics \ One and Done\ \ Standard\ p value Number Age 56 years 58 years 0.61 Male Gender (n) Time from Acute Pancreatitis 8.3 weeks 8.8 weeks 0.87 to First Intervention Maximum Collection Size 10.1 cm 10.3 cm 0.83 Amount of Solid Debris within PFC 45.4% 45.8% 0.97 Size of Maximum Cystenterostomy Dilation 16.9 mm 14.4 mm 0.11 Primary Clinical Outcomes \ One and Done\ \ Standard\ P Value Number WOPN Resolution 96% (23/24) 83% (10/12) 0.25 Time to Resolution 1.7 months 3.0 months 0.04 Number of Procedures Nasocyctic Tube 0% 50%!0.01 Subsequent Infection 0% 21% 0.14 Mo1421 Biliary Intervention in Patients With History of Bariatric Surgery: Associations and Outcomes of Failed-ERCP Mohammad H. Shakhatreh* 1, Alice Hinton 2, Samer El-Dika 1, Darwin Conwell 1, Somashekar G. Krishna 1 1 Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, Columbus, OH; 2 Division of Biostatistics, School of Public Health, The Ohio State University, Columbus, OH Background: Patients with history of bariatric surgery (BRS) are at a higher risk for developing gallstones and endoscopic retrograde cholangiopancreatography (ERCP) is difficult after Roux-en-Y gastric bypass surgery. Aim: Compare the associations and outcome of successful versus failed-ercp in patients with BRS. Methods: The Nationwide Inpatient Sample ( ) was reviewed for all adult patients (R18 years) with BRS undergoing ERCP. Failed ERCP was defined as percutaneous biliary intervention or surgical common bile duct exploration performed % 7 days after ERCP. Demographic, hospital, etiological differences and outcomes of successful versus failed-ercp were analyzed. Results: There were a total of 4,482 patients with history of BRS who underwent primary inpatient ERCP. Among them, 3,956 patients had a successful ERCP (88.3%) while 526 had a failed ERCP (11.7%). Gallstone related etiologies were the most common indication (50.2%) for ERCP. Nearly half (51%) of ERCPs were performed within 1 day of hospital stay. Patients with failed-ercp were older (53.4 vs. 49.7, p!0.05) and were more common in large hospitals (p!0.05). There were no differences in other variables (table 1). Adjusting for demographic, hospital, and etiological differences, failed-ercp patients had a significantly higher rate of sepsis (Adjusted odds ratio 3.1, 95% CI 1.3, 7.4). Multivariate analysis also revealed that patients with failed-ercp had a prolonged hospital stay by an average of 2.2 days (95% CI 1.2, 3.2) and incurred higher hospital charges by an average of $14,000 (95% CI $ 3,538, 24,510). The overall mortality for all BRS patients undergoing ERCP was 0.2% (10 of 4,482 patients). There was no attributable mortality for failed-ercp in BRS patients (table 1). Conclusion: Despite the absence of any associated mortality, failed-ercp rates for hospitalized BRS patients are high and account for higher health care utilization. Since bariatric surgeries are increasing, there is a need for focused research in improving biliary access in this patient population. Table 1. Demographics, etiological associations, and outcomes of patients undergoing inpatient ERCP with a history of bariatric surgery Successful ERCP Failed-ERCP p- N % N % value Total 3, ! Age (mean, SD) Female Male 3, Race Income (Quartiles) Type of insurance Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB413
19 Successful ERCP Failed-ERCP p- N % N % value Hospital location/teaching status Hospital size: Small Hospital size: Medium Hospital size: Large 2, Hospital region Weekend Admission Elixhauser comorbidity index Time to ERCP Complications: Sepsis Complications: Acute renal failure Complications: Acute pancreatitis Complications: Cholangitis Complications: Acute respiratory failure Outcome: Death Outcome: Length of ! stay R7 days Outcome: Length of ! stay (mean, SD) Outcome: Total charges (mean, SD) 48,981 41,197 63,200 45, Mo1422 Clinical Presentation, Radiological Features & Endoscopic Management of Splenic Pseudocysts Deepak K. Bhasin*, Surinder S. Rana, Ravi Sharma, Vishal Sharma, Rajesh Gupta Postgraduate Institute of Medical Education & Research, Chandigarh, India Background: Splenic pseudocyst is a rare complication of acute as well as chronic pancreatitis. There is paucity of data on its clinical as well as imaging features. Moreover, surgery/radiological drainage has been conventional treatment with limited experience of endoscopic drainage. Objective: To study clinical and radiological characteristics of splenic pseudocysts as well as role of endoscopic drainage and clinical outcome in these patients. Methods: We performed a retrospective analysis of patients with splenic pseudocysts seen at our institution over past 12 years. Clinical records were reviewed to identify patient symptoms and imaging findings. All patients were treated with attempted endoscopic transpapillary drainage with a nasopancreatic drain (NPD) or stent. The patients not responding underwent EUS guided transmural drainage or radiological drainage. Results: Nine patients (all males; mean age: years) with symptomatic splenic pseudocysts were seen at our centre. Seven patients had chronic pancreatitis and 2 patients had pseudocysts as sequelae of acute pancreatitis. Majority of the patients (8/9; 89%) had alcohol as the etiology for underlying pancreatitis with 1 patient having idiopathic chronic pancreatitis. All patients had abdominal pain and 3/9 (33%) patients had fever. The size of pseudocysts ranged from 2.5 to 15 cm (mean:6.8 cm). Three patients had coexistent abdominal pseudocyst and 4/9 (44%) patients had left sided pleural effusion. These pseudocysts were well demonstrated on contrast enhanced computed tomography (CECT). EUS was done in 3 patients and pseudocyst could be well demonstrated and two patients had echogenic contents. ERPwasdoneinallpatientsandallof them had single partial disruption. The disruption could be bridged in all patients and5frnpdwasplacedin4patients,5frstentin3and7frstentin1patients respectively. Seven patients (78%) had marked improvement in their symptoms following endoscopic drainage and all the pseudocysts including the splenic pseudocysts resolved within 8 weeks (mean 5.7 weeks). Two patients with fever and echogenic contents did not improve after transpapillary drainage and were treated with single time EUS guided complete aspiration of the infected pseudocyst. One patient improved whereas other patient continued to be febrile. He developed hematemesis accompanied with hemodymanic compromise because of splenic artery pseudoaneurysm and needed surgery. There has been no recurrenceofsymptomsinthese8successfullytreated patients over a follow up period ranging from 6 months to 12 years. Conclusions: Endoscopic transpapillary drainage is a safe and effective modality for treatment of splenic pseudocysts especially when they are not infected, there is partial ductal disruption and the disruption can be bridged by an endoprosthesis. Mo1423 The Effect of Pancreatic Duct Stenting on Clinical Outcomes in Patients Undergoing Endoscopic Cystenterostomy for Pancreatic Fluid Collections Stuart R. Gordon*, Sarah M. Hyder, Kartik Sampath, Timothy B. Gardner Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH Background & Aims: By definition, pancreatic fluid collections arise in the context of a disrupted main or secondary pancreatic duct. It is unclear whether performing pancreatic duct stenting in addition to cystenterostomy helps to resolve pancreatic fluid collections. We aimed to determine whether transpapillary drainage contributes to successful clinical outcomes in patients with pancreatic fluid collections. Methods: We evaluated all patients who underwent endoscopic cystenterostomy at our medical center for treatment of a pancreatic pseudocyst or walled off pancreatic necrosis arising in the context of pancreatitis. A retrospective chart review identified demographic, clinical and outcome measures. The primary outcome of interest was the resolution of the collection. Univariate analysis followed by a multivariate logistic regression model was then built to identify predictors of a successful outcome. Results: 84 patients underwent cystenterostomy for treatment of pancreatic fluid collections at our center from and complete outcome data was available on 79. Table 1 demonstrates baseline patient characteristics stratified by whether or not the patient had a pancreatic duct stent placed. Only the size of maximum cystenterostomy dilation (11 mm vs 14 mm, pz0.01) differed between groups. Table 2 demonstrates the primary clinical outcomes. The chance of successful resolution, time to resolution, complications and rate of subsequent infection did not differ between groups. However, patients who did not have a pancreatic stent had fewer overall endoscopic procedures than those with a pancreatic stent. Adjusting for potential confounders via a multivariate logistic regression model did not significantly affect the univariate findings. Conclusion: In patients undergoing cystenterostomy for pancreatic fluid collections, the placement of a transpapillary stent did not improve the chance at successful resolution, but did increase the number of overall endoscopic procedures. Table 1. Baseline Patient Characteristics of Patients With and Without Pancreatic Stents Pancreatic Duct Stent No Pancreatic Duct Stent P Value Number Age 57 years 57 years 0.99 Maximum Collection Size (cm) 10.3 cm 10.5 cm 0.84 WOPN Time from Pancreatitis to First 10 weeks 17 weeks 0.21 Endoscopy Amount of Solid Debris 23% 27% 0.63 within PFC Size of Maxium 11 mm 14 mm 0.01 Cystenterostomy Dilation Number of Stents Placed Male Gender Table 2. Primary Clinical Outcomes of Patients with and Without Pancreatic Stents Pancreatic Duct Stent No Pancreatic Duct Stent P Value Number PFC Resolution 85% 94% 0.34 Time to Resolution 2.2 months 2.8 months 0.42 Number of Procedures Complication 4.5% 17.5% 0.13 Subsequent Infection 9% 12% 0.31 Mo1424 Utilization of Deep Sedation for ERCP in Hospitalized Patients With Choledocholithiasis: Patterns of Care and Associated Outcomes Lauren G. Khanna*, Ashley Mcfarland, Jason Wright, Alfred I. Neugut, Fay Kastrinos Columbia University Medical Center, New York, NY Background: Patient and procedure-related factors influence the sedation type selected for endoscopy. ASGE guidelines consider use of deep sedation for long or complex procedures such as ERCP. To date, studies of moderate conscious versus AB414 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
20 deep sedation with propofol for ERCP have evaluated short-term outcomes such as patient tolerance of procedure, technical success, and recovery time, and most are limited to single centers with few patients. Our aim was to assess utilization of deep sedation with propofol among inpatients undergoing ERCP for choledocholithiasis and compare outcomes of mortality, complications, length of stay (LOS), and hospitalization cost between those who received deep sedation and those who did not. Methods: This cross-sectional study included hospitalized patients with a diagnosis of choledocholithiasis who underwent ERCP between 2006 and Data was obtained from the Perspective database, a validated dataset of inpatient admissions from O500 hospitals nationwide created to measure quality and health care utilization. Patient and hospital characteristics were compared by Chi-square and t-tests, and multivariable analysis was used to determine the effect of deep sedation on outcomes of in-hospital mortality, complications, LOS, and hospitalization cost. Results: We identified 60,342 eligible patients, of which 26,244 (43.5%) had deep sedation with propofol. The proportion of ERCP cases with propofol increased from 28.8% (2006) to 53.2% (2012). Mean age of the population was years (62.3 with propofol, 65.1 without, p!0.0001). Patient characteristics inversely associated with propofol use were older age, Medicare insurance, and multiple comorbidities. Hospital characteristics inversely associated with propofol use were teaching status and larger hospital size. In-hospital mortality following ERCP was 1.2% (1.1% with propofol, 1.3% without, p!0.0001), rate of any complication was 38.2% (37.2% with propofol, 39.0% without, p!0.0001), LOS was 6.1 days (6.1 with propofol, 6.2 without, pz0.13), and hospitalization cost was $13,1277,463 ($13,414 with propofol, $12,905 without, p!0.0001). Adjusting for patient and hospital characteristics on multivariable analysis, hospitalization cost was $759 greater with propofol (p!0.0001) but there were no differences in in-hospital mortality (OR % CI ), rate of any complication (OR % CI ), and LOS (1.05 days more with propofol, 95% CI ) between those who received propofol and those who did not. Conclusions: Utilization of propofol for ERCP in hospitalized patients with choledocholithiasis has increased. Selection of patients for deep sedation with propofol should be based on patient characteristics, irrespective of hospital characteristics and resources, as clinical outcomes are comparable and hospitalization cost differences are negligible. Mo1425 Utilization Trends of Endoscopic Retrograde Cholangiopancreatography (ERCP) From in a Large US Endoscopic Database Brintha K. Enestvedt* 1, Sarah B. Rodriguez 2, Jennifer L. Maranki 3, Gennadiy Bakis 1, Sharlene D Souza 1, Jeffrey L. Williams 1, David A. Lieberman 1, M. Brian Fennerty 1 1 Medicine, Oregon Health & Science University, Portland, OR; 2 The Oregon Clinic, Portland, OR; 3 Temple University, Philadelphia, PA Background: Epidemiological studies using the Nationwide Inpatient Sample (NIS) and State Ambulatory Surgery Database (SASD) in the U.S. as well as studies from Canada, China and Norway have examined the clinical use of ERCP. However, large population-based data from the United States (US) over the past 10 years are lacking. The aim of this study was to examine the trends and utilization of ERCP across various practice types in the US using the Clinical Outcomes Research Initiative (CORI) database. Methods: The CORI database was queried from to identify all ERCPs performed. Data examined included age, gender, ethnicity, ERCP position, indications for ERCP (stratified as biliary or pancreatic), location of procedure (inpatient vs outpatient, practice type), type of sedation used and findings. Immediate adverse events defined as an unplanned event requiring an intervention were recorded. Univariate statistics and Cochran Armitage test of trend were utilized. Results: During the study period, 39,011 ERCPs were performed on 26,943 unique patients at 38 distinct practice sites. The number of yearly ERCPs has steadily increased over the time period from 1,074 in 2000 to 1,907 in 2013 in stable practice sites (total 25,008) (p!0.0001). The mean age of patients was 58.4 years (18.1). Male patients comprised 50.7% of the patients; the majority, 69.2% were white non- Hispanic. The proportion of procedures performed in the academic and community/ HMO setting was similar, 40.5% and 42.0% respectively (17.5% VA/military). Outpatient ERCP accounted for 43.4% of the total (inpatient, 43.5%, unknown 13%). Prone positioning was used for 67.3% of ERCPs. Overall, 30.4% of ERCPs were performed utilizing moderate conscious sedation, 28.5% general anesthesia, and 14.5% deep sedation (monitored anesthesia care, 26% unknown). The proportion of ERCPs performed with moderate conscious sedation has significantly decreased over time (Figure 1) (p!0.001). Evaluation of a suspected biliary diagnosis accounted for 71.8% of ERCP indications. Findings included filling defects or stones 31.8%, stricture 21.3%, ductal dilation 27.2%, leak/extravasation 3.1%, and normal 22.9[BE1] %. Overall, only 4.1% of ERCPs involved an accompanying endoscopic ultrasound on the same day. However, this trend has increased significantly over the time period (Figure 2) (p!0.0001). The immediate serious adverse event rate requiring an intervention was 1.3%. Conclusion: In a large US endoscopic database of diverse practice sites, the number of ERCPs being performed yearly has increased over time. There has been a shift in sedation for ERCP away from moderate conscious sedation. Concomitant EUS/ERCP in the same day represents a small proportion of ERCPs but shows an increasing trend. These results represent the largest multicenter ERCP dataset from inpatient and outpatient practices. Mo1426 Development of a Prediction Model for Unplanned Admission Following Endoscopic Retrograde Cholangiopancreatography Gregory A. Cote 1, Huiping Xu 2, Sheryl Lynch 3, Jeffrey J. Easler* 3, Alyson Keen 4, Patricia A. Vassell 4, Stuart Sherman 3 1 Medicine, Division of Gastroenterology & Hepatology, Medical University of South Carolina, Charleston, SC; 2 Biostatistics, Indiana University School of Medicine, Indianapolis, IN; 3 Medicine, Division of Gastroenterology & Hepatology, Indiana University School of Medicine, Indianapolis, IN; 4 Indiana University Health, Indianapolis, IN Background & Aims: In outpatients undergoing ERCP with anesthesia-administered sedation, rates of and risk factors for admission are unclear. We hypothesized that a regression model including patient, procedure, and post-procedure factors could accurately distinguish populations at high- and low-risk for unplanned admission. Such a model could improve the triage of patients to fasttrack discharge or admission for observation. Methods: We conducted a cohort study including ERCPs performed on outpatients 5/ /2013. Medical records were abstracted for pre-, intra- and early post-procedure, the latter defined by the first hour in the postoperative care unit (POCU). We performed bivariate comparative testing to identify factors potentially associated with unplanned admission during each stage of care. Significant factors associated with admission were incorporated into a regression model to identify subgroups having low, moderate, or high probability for admission. The population was divided into a training (first 12 months) and validation (last six months) cohort to establish and then test the model. Results: We identified 3,709 ERCPs during the study period; admission and post-ercp pancreatitis rates were 11.3% and 3.6%, and similar between the training and validation cohorts. Factors associated with admission included high-risk indications, greater comorbidity, higher baseline pain, longer procedure duration, performance of sphincter of Oddi manometry, higher pain during the first hour of recovery, and greater use of opiates or antiemetics (table). A multivariate logistic regression model had good accuracy (AUCZ0.83) in distinguishing patients requiring admission or discharge in the training and fair accuracy (AUCZ0.76) in the validation cohort. The model s performance improved as risk factors expanded from pre-procedure to include intra-procedural and those during the first hour in POCU (figure). Using this model, O50% of patients could be classified as low risk for admission, theoretically facilitating fast-track discharge. Conclusion: Admission rates following outpatient ERCP are low, suggesting a universal policy of prolonged observation is unnecessary. A regression model including factors through the first hour post-procedure can reasonably identify patients who could be triaged expeditiously. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB415
21 Table. Multivariate regression model to distinguish patients admitted or discharged following ambulatory ERCP Variable Odds ratio (95% CI) p value Pre-procedure factors Number of major comorbidities 2.15 (1.68, 2.76)! Number of non-major comorbidities 2.39 (1.61, 3.56)! Female sex 2.86 (1.73, 4.72)! ERCP indication: Bile duct obstruction 0.39 (0.23, 0.66) Intra-procedural factors ERCP manuever: Stent placement 2.02 (1.27, 3.21) ERCP time (per minute) 1.03 (1.02, 1.03)! ERCP manuever: Sphincter of Oddi manometry 2.47 (1.45, 4.23) Post-procedure factors (first one hour) Pain (area under the pain curve) 1.19 (1.07, 1.32) Analgesic requirement (morphine equivalent 1.06 (1.02, 1.11) dose, per mg) Risk factors, as defined by odds ratios, for unplanned admission following ERCP in the outpatient setting. Pain was defined using a 10-point visual analog scale; pain during the first one hour was defined using a weighted average of pain scores during this period (a.k.a., area under the pain curve). The only variable associated with a significantly lower odds of admission was having an indication for ERCP of bile duct obstruction. Figure. Receiver Operating Curves for cumulative stages of care. Receiver operating curves are shown for the training (a) and validation (b) cohorts. We developed four models using significant factors during pre-procedure, pre-procedure + intraprocedural, pre-procedure + intraprocedural + first hour in POCU, all three prior stages + second hour in POCU. Each model was rated fair to good based on the AUC; training cohort: 0.76 (pre), 0.80 (pre, intra), 0.82 (pre, intra, post one hour), 0.83 (pre, intra, post 2 hours); validation cohort: 0.70 (pre), 0.74 (pre, intra), 0.76 (pre, intra, post one hour), 0.78 (pre, intra, post 2 hours). POCU Z postoperative care unit. Mo1427 ERCP in EST-NaïVE Patients With Advanced Liver Cirrhosis Jong-Chan Lee*, Kyu-Hyun Paik, Hyoung Woo Kim, Yoon Suk Lee, Jin-Hyeok Hwang, Jaihwan Kim Seoul National University Bundang Hospital, Seongnam-si, Korea (the Republic of) Background: Although endoscopic retrograde cholangiopancreatography (ERCP) is not contraindicated in patients with advanced liver cirrhosis (LC), coagulopathy is a practically common obstacle. This study aims to assess the results of ERCP in endoscopic sphincterotmy (EST)-naïve patients with advanced LC. Methods: In a single tertiary teaching hospital, total 102 EST-naïve patients with LC who had undergone ERCP were identified between 2003 and Advanced LC was defined as Child-Pugh-Turcotte (CPT) class C and non-advanced LC as CPT A or B. Results: There were 23, 55 and 24 patients in each CPT group A, B and C, respectively. Male were 72 (70.6%) and median age was 62 years. Indications of ERCP were CBD stone (63.7%), malignant biliary obstruction (20.6%), and others (16.7%). There were significant differences of mean prothrombin time (1.16, 1.22, and 1.69 international normalized ratio, P!0.001) and platelet counts (125K, 126K, and 88K/μl, PZ0.008). Before ERCP, 6 (7.7%) and 10 (41.7%) of non-advanced and advanced LC patients received fresh frozen plasma or platelet transfusion. Compared with ERCP success rate of non-advanced LC group (96.2%), that of advanced LC group (79.2%) was significantly lower (PZ0.015). However, there was no difference of cumulative success rates after the 2nd or 3rd ERCP between non-advanced (98.7%) and advanced LC groups (91.7%) (PZ0.125). Among 8 cases with initial ERCP failures, 2, 1 and 5 was in CPT group A, B and C, respectively. Causes of ERCP failure were three bleeding tendency, three difficult biliary accesses, one incompliant patient and one choledochoduodenal obstruction. Conclusion: Although initial ERCP results in patients with advanced LC were inferior to those with non-advanced LC, bleeding was not a direct cause of this difference. Considering insignificant difference of eventual success rates between advanced and non-advanced LC patients, ERCP is feasible in patients with advanced LC after proper preparation. Mo1428 Hemoclip Application Using CAP-Fitted Forward Endoscopy to Treat Post-Sphincterotomy Bleeding in Patients Undergoing ERCP Tae Hyeon Kim* 1, Young Woo Sohn 2 1 Internal Medicine, Wonkwang University Hospital, Iksan, Korea (the Republic of); 2 Internal Medicine, Wonkwang University Sanbon Hosptial, Iksan, Korea (the Republic of) Background: The risk of immediate or delayed bleeding following endoscopic biliary sphincterotomy (ES) during endoscopic retrograde cholangiopancreatography (ERCP) is reported from %. Clinically, bleeding can range from insignificant to life threatening. Although endoscopic clipping may effective method treatment of a wide variety of bleeding lesions of GI tract, mechanical clipping of post-es bleeding has not been widely studied, in part due to the difficulty in placing the current generation of clips using ERCP endoscopes. A cap-fitted forward viewing endoscope can easily visualize the ampulla of Vater. Aim: To determine the efficacy of a capfitted endoscopy to treat bleeding on the bleeding on the ES site in patients who undertook ERCP with ES. Patients and Methods: The study included 1,248 consecutive patients who underwent 1,248 ERCP with ES procedures between January 2011 and August ES-induced hemorrhage occurred in 45 patients (3.6%). Bleeding patterns (trickle, oozing, pulsatile, and exposed vessel) were recorded. Patients with oozing or trickle bleeding who did not respond to balloon compression or epinephrine solution injection and all the patients with pulsatile bleeding and/or exposed vessel on the ES site, received clipping. Result: The mean age was and sex ratio (M/F) was 32 (71.1%): 13 (28.9%) in 45 patients. Thirty nine patients had immediate endoscopic visible bleeding signs during ES, and 6 patients without endoscopic visible bleeding signs during ES who did not undergo clipping (0.48%) presented with delayed hemorrhage. Visible bleeding pattern following ES were: 19 trickle (42.2 %), 22 oozing (48.9 %), 3 pulsatile (6.7 %), and 1 exposed vessel (2.2%). Hemostasis was achieved by clipping in 45 of 45 patients (100%) who included patients with antiplatelet drug (nz9) and warfarin (nz2). The median number of clips used in all patients was 2.0 (range: 1-3). No patients had evidence of delayed bleeding after clipping on all visible bleeding signs. No patients had evidence of complication related to this procedure after clipping. Conclusion: Hemoclip application using cap-fitted forward viewing endoscopy is feasible, safe and may be an effective technique for the treatment and/or prevention of post-es bleeding. Mo1429 Short-Term Stenting With Short Fully Covered Self-Expandable Metal Biliary Stents for Post-Sphincterotomy Bleeding: Prospective Evaluation of Outcomes and Safety Javier Jiménez-Pérez*, Juan J. Vila, Ignacio Fernandez-Urien Endoscopy Department, Complejo Hospitalario Navarra, Pamplona, Spain Introduction: Bleeding after endoscopic sphincterotomy (ES) is a recognized adverse event of the technique. In case of moderate or severe bleeding that requires intervention, endoscopic therapy with injection, thermal or mechanical methods has proved to be effective. However, it is usually challenging and difficult to apply these methods through the working channel of a duodenoscope. Several studies have been published reporting the outcomes of temporary placement of a fully covered self-expandable metal biliary stent though timing of stent removal is very variable and there is no agreement concerning the optimal stent length. Material and Methods: We prospectively evaluated the effectiveness of short-term temporary placement of a short fully covered self-expandable metal stent in patients with immediate bleeding or clinically significant delayed bleeding due to an ES. We analysed technical and clinical success (initial and definitive hemostasia after stent removal) and the incidence of stent related complications (migration, pancreatitis and cholecystitis). Results: From July 2012 to June 2014, 808 biliary endoscopic sphincterotomies were performed in a total of 837 ERCPs. 13 patients (1.6%) presented post ES bleeding, immediate in 7 cases (53.8%) and delayed in 6 cases (46.2%), with indication for endoscopic treatment. A 10 mm diameter fully covered biliary WallFlex stent (BSC, Natick USA) was successfully inserted in every patient (technical success: 100%) as first choice treatment. A 6 cm stent was placed in 1 patient due to the presence of a malignant common bile duct stricture and a 4 cm stent in 12 patients. Initial hemostasia was achieved in all patients (initial clinical success: 100%). In 11 patients the stent was removed after a median time of 6 days (4-7 days) and re-bleeding did not occur after stent removal in any patient. In one patient the stent was not endoscopically removed as he was further operated of a AB416 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
22 pancreatic cancer and the stent was removed en bloc with the surgical specimen. During follow-up from stenting to surgery (63 days), bleeding did not relapse. In one patient (7.7%) the stent migrated 4 days after stent insertion but no signs of rebleeding were observed (definitive clinical success: 100%). Two patients (15.4%) presented a mild pancreatitis which did not require premature stent withdrawal. No cases of cholecystitis were registered among the 8 patients with gall-bladder. Conclusions: 1. Short-term stenting proves to be an effective alternative to achieve initial and definitive hemostasia in post-sphincterotomy bleeding, avoiding potential stent related late complications as stent occlusion and associated cholangitis. 2. The use of short stents is effective and reduces the risk of secondary cholecystitis. 3. Cost/effectiveness studies are needed before considering stenting as the first choice treatment. Mo1430 The Biodurability of Advanced Hydrophilic Coating for Plastic Stents in a Bile Flow Phantom and a Swine Bile Duct Dilation Model Chang-Il Kwon* 1, Gwangil Kim 3, Seok Jeong 2, Don Haeng Lee 2, Kwang Hyun Ko 1, Ki-Baik Hahm 1, Sung-Pyo Hong 1 1 Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea (the Republic of); 2 Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea (the Republic of); 3 Department of Pathology, CHA Bundang Medical Center, CHA University, Seongnam, Korea (the Republic of) Background/Aims: In order to overcome short stent patency time of plastic stents due to biofilm formation, newly improved plastic stents have been developed. The aim of this study was to evaluate whether plastic stents with advanced hydrophilic coating have longer patency and more improved biodurability. Materials and Methods: The bile flow phantom model containing various types of 10F plastic stents provided continuous circulation of fresh human bile. Various typesofplasticstentswerealsoinsertedintothebileductof7swinebileduct dilation models. We performed an analysis of the degree of luminal narrowing by microscopic examination, and inner surface examination by scanning electron microscopy (SEM) of the removed stents. Results: In an in vitro bile flow phantom, biofilm formation was rarely observed in all stents 4 weeks after bile exposure. After 8 weeks of bile exposure, the plastic stent with hydrophilic coating (PS+HC) showed less formation of biofilm and less luminal narrowing than the plastic stent without hydrophilic coating (PS-HC) (p!0.001). A total of 31 stents were inserted into the bile duct of 7 swine model, and 24 stents could be retrieved among them 8 weeks later. The polyethylene PS+HC had a tendency to form more biofilm and to make the lumen narrower than polyurethane PS+HC (pz0.062). In SEM examination, the hydrophilic coating layer was sustained until 8 weeks. Conclusions: The PS+HC tended to form biofilm less frequently than PS- HC. Polyurethane seemed to be more patent and durable than polyethylene in hydrophilic coating techniques. Mo1431 The Use of Fully Covered Self Expandable Metallic Stent in ERCP Related Type-2 Perforations Bulent Odemis, Erkin Oztas*, Ufuk B. Kuzu, Erkan Parlak, Selcuk Disibeyaz, Serkan Torun, Ertugrul Kayacetin Gastroenterology, Yuksek Ihtisas Education and Research Hospital, Ankara, Turkey Background and Objective: The conservative management of endoscopic retrograde cholangiopancreatography (ERCP) related retroperitoneal duodenal perforations (Type-2) involves cessation of oral feeding, parenteral hidration, use of wide-spectrum antibiotics, antiacid therapy and nasobiliary(nbd) or nasogastric drainage catheter placement simultaneously with ERCP. To date, there are no any other studies evaluating the use of fully covered self expandable metallic stent (SEMS) simultaneously with nasobiliary drainage (NBD) and the effect of it to the clinical course of the patients. Methods: Data of the patients diagnosed as ERCP related Type-2 perforation, between January 2007 and August 2014 in the our clinic were retrospectively analyzed. NBD group was consisted of the patients treated with conservative management. The patients treated with additional placement of fully covered SEMS to common bile duct were entitled as NBD and SEMS group. Results: There were 17 patients with ERCP related Type-2 perforation (9 in NBD group and 8 in NBD and SEMS Group). The mean age of the patients were and years, in NBD group and in NBD and SEMS group, respectively(pz0.56). 66.6% in NBD and 75% in NBD and SEMS group, CBD stone was the indication for ERCP. Perforation related length of stay in hospital were days in NBD group and days in NBD and SEMS group (pz0.09). There was statistically significant difference for pain requiring the use of non-steroidal or narcotic analgesics among groups, with 55.6% (nz5) in NBDgroupwhilenoneinNBDandSEMSgroup(pZ0.017). Fever was determined during follow-up in 50% (nz4)andin37.5%(nz3) of patients in NBD group and in NBD and SEMS group respectively (pz0.61). The mean white blood cell count of the patients in NBD group was /mm 3 and / mm 3 in NBD and SEMS group, before the procedure (pz0.82). In NBD group, the percentage of patients with leucocytosis were 88.9%(nZ8), 66.7%(nZ6), 22.2%(nZ2) and 22.2%(nZ2) on the first, third, fifth and seventh days, respectively. In NBD and SEMS group, the percentage of patients with leucocytosis were 50%(nZ4), 37.5%(nZ3), 25%(nZ2) and 12.5%(nZ1) on the first, third, fifth and seventh days, respectively. The difference of the percentage of the patients with leucocytosis in the first day of the procedure was tended to be statistically significant (pz0.07). There were no need for surgical intervention and neither mortality in both groups. Conclusions: Additional usage of SEMS to conservative management in patients with ERCP related Type-2 perforations, significantly decreased the pain during the follow-up period. Also the development of fever and leucocytosis was considerably reduced inpatientstreatedwithsems,butthe difference just missed the level of significance probably due to the small sample size in the present study Figure 1a. The orifice of the perforation was seen at the lateral wall of the papilla secondary to sphicterotomy (white arrow), 1b: The view after the placement of fully covered self expandable metallic stent, 1c; The orifice was completely obliterated at the tenth day of the procedure after the displacement of both nasobiliary drainage catheter and self expandable metallic stent (black arrow) Mo1432 Is There Need for More Randomized Controlled Trails to Evaluate the Role of Prophylactic Antibiotics Before ERCP? a Meta-Analysis of Randomized Controlled Trials. Bhupinder S. Romana* 1, Sameer Siddique 1, Harathi Yandrapu 2, Prashanth Vennalaganti 2, Sreekar Vennelaganti 2, Rindi M. Uhlich 1, Sravanthi Parasa 3, Tarun Rai 3, Vijay Kanakadandi 3, Ajay Bansal 2, Prateek Sharma 2,3, Abhishek Choudhary 2 1 Gastroenterology, University of Missouri-Columbia, Columbia, MO; 2 Gastroenterology, Kansas City Veterans Affairs Medical Center, Kansas, MO; 3 University of Kansas School of Medicine, Kansas, KS Background: Infections following ERCP are a dreaded complication with increased morbidity and mortality in severe cases. Despite numerous small scale randomized controlled trials over the last 3 decades, the outcomes and recommendations have varied. We conducted a meta-analysis to investigate the role of prophylactic antibiotics in reducing the risk of post- ERCP cholangitis and post-ercp pancreatitis. Methods: MEDLINE/PubMed, EMBASE, Cochrane Central Register of Controlled Trials and Database of Systematic Reviews, and recent abstracts from major conference proceedings were searched (November 2014). Randomized studies comparing prophylactic antibiotics vs. no antibiotics for all ERCP s (diagnostic and therapeutic) were included. Pooled estimates of post ERCP cholangitis, bacteremia, pancreatitis and mortality were analyzed by using odds ratio (OR). Random and fixed effects models were used as appropriate. Publication bias was assessed by funnel plots. Heterogeneity among studies was assessed by calculating I!+O2!+O measure of inconsistency. Results: Ten randomized controlled trials with total of 1705 procedures met inclusion criteria. All trials were of adequate quality. All the trials had subjects undergoing both diagnostic and therapeutic ERCP. Indications varied but included significant numbers with obstructive jaundice due to stones or malignancy. Majority of the trials administered antibiotics for prophylaxis 30 minutes to 1 hour before the procedure. Differing antibiotics utilizing varying routes were used in these trials with six trials notably administering cephalosporins and two trials using piperacillin. Post ERCP cholangitis was noted in 3.8 % in the antibiotic group vs. 5.8% in placebo group. On pooled analysis, significantly low odds of post ERCP cholangitis and pancreatitis were noted in antibiotic group when compared to the placebo group (OR Z 0.63; CI: ; p Z 0.04; I 2 Z 25%, OR Z 0.37; CI: ; p Z 0.03; I 2 Z 0%) with no significant heterogeneity. A trend towards decrease in other infective complications with antibiotics was noted but did not reach statistical significance (OR Z 0.64; CI: ; p Z 0.06; I 2 Z 3.7%). No significant effect was noted for mortality ((OR Z 1.02; CI: ; p Z 0.97; I 2 Z 0%). Conclusion: Prophylactic antibiotic administration before ERCP decreases odds of cholangitis and pancreatitis. However, future large size randomized controlled trials will need to investigate the role of antibiotic prophylaxis under different clinical scenarios, irrespective of resolution of biliary obstruction. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB417
23 Mo1433 Management of ERCP-Related Perforations: Outcomes of Single Institution in Japan Hiroyuki Hisai*, Tasuku Hirako, Yutaka Koshiba, Yuuki Ikeda, Shogo Miura, Etsu Miyazaki Department of Gastroenterology, Japanese Red Cross Date General Hospital, Date, Japan Background: Endoscopic retrograde cholangiopancreatography (ERCP) is an established procedure for various pancreticobiliary diseases. ERCP-related perforations are uncommon (incidence of 0.08%-2.2%), though associated with a high mortality rate of 4.2%-29.6%. These data stems mainly from older studies or retrospective databases of tertiary referral centers. The aim of this study was to determine the incidence and outcome of ERCP-related perforations in the district general hospital setting. Methods: A retrospective chart review was conducted to identify patients treated at our institution for ERCP-related perforation. Study variables were included indication for ERCP, diagnostic procedure, location of injury, management and outcome. Perforation following ERCP was divided, according to Kim classification based on the instrument that caused the perforation (J Korean Surg Soc 2011). Injury by endoscopic tip or insertion tube was classified as type I, injury by cannulation catheter or sphincterotomy knife as type II, and injury by guidewire of bile duct or pancreatic duct as type III. Results: Between April 1996 and November 2014, a total of 6235 ERCPs were performed (73.4% therapeutic interventions), and perforation occurred in 31 patients (0.497%; 18 men, 13 women, mean age 75.4 years, range, years). The indications for ERCP were choledocolithiasis in 16 patients (52%), malignant biliary strictures in 9 (29%), cholecystitis in 2 (6%), and one case each of intrahepatic bile duct stricture, gallbladder tumor and pancreatic cystic tumor. We identified 6 type I, 12 type II, and 13 type III perforations. In all patients except one, perforation was recognized during ERCP. Regarding type I perforation, two patients had lateral duodenal perforation and four had a perforation of an afferent limb of a Billroth II reconstruction. Type II perforations were related to sphincterotomy (nz4) and procedures following sphincterotomy (nz8). Twenty-five out of 31 (81%) were managed medically with endoscopic or percutaneous transhepatic drainage. Of these, endoscopic closure with metallic clips was performed in one patient with type I perforation. Two patients (type II in 1 and type III in 1) were treated with fullycovered self-expandable metal stents. EUS-guided drainage for walled-off necrosis was required in one patient with Type III perforation of the main pancreatic duct. The remaining 6 patients (type I in 5 and type III in 1) underwent surgery. There were two mortality cases with unstable general conditions (type I in 1 and type III in 1). Conclusions: Although most patients fully recovered from perforation, however, some patients experienced life-threatening outcomes, including mortality. Scoperelated perforation is a serious complication requiring surgery. Immediate diagnosis and appropriate management is crucial for optimal results. Mo1434 A Prospective Comparative Study to Determine Quality Outcomes of Endoscopic Retrograde Cholangiopancreatography, Performed by Gastroenterologists and Surgeons in a Tertiary Referral Setting. Marie Ooi*, Ken Liu, Santosh Sanagapalli, James L. Cowlishaw, Gavin Barr Gastroenterology, Concord Hospital, Sydney, NSW, Australia Background: Endoscopic retrograde cholangiopancreatography (ERCP) is generally performed either by a surgeon or a gastroenterologist. Given ERCP carries a relatively high risk of complications, quality assurance is vital. The American Society for Gastrointestinal Endoscopy (ASGE) Committee defined quality indicators for ERCP as pre-procedural assessment of the appropriateness of indication, procedural and technical success (i.e biliary cannulation rates), and post-procedural outcomes. To date, there is limited comparative data assessing the quality outcomes of ERCP performed by gastroenterologists and surgeons. Aims: To compare quality indicators of ERCPs performed by gastroenterologists and surgeons in a tertiary referral centre. Methods: We prospectively assessed ERCPs performed over a 7-month period. Data included age, indication for ERCP, proceduralist, biliary cannulation rate, ERCP related complications, length of stay (LOS) & mortality. Chi square tests were performed to compare performance of ERCPs performed by gastroenterologists vs. surgeons. Results: There were 112 ERCPs performed over this period, 86 (77%) by gastroenterologists vs 26 (23%) by surgeons. 66 were inpatients. Mean age was 71.6 vs 73.4 yrs in the surgical and gastroenterology groups, respectively (pz0.87). The technical success in biliary cannulation was 96% vs 83% for the gastroenterology and surgical group, respectively (pz0.04). The indications for ERCP in gastroenterology versus surgical cohort were cancer related obstructive jaundice (nz12 vs 12), choledocholithiasis or positive intraoperative cholangiogram (nz22 vs 4), cholangitis (nz39 vs 3), bile leak post cholecystectomy (nz1 vs 1), and biliary stricture (nz12 vs 6). In terms of ERCP-related complications, the rate of post-ercp pancreatitis (PEP) in the surgical vs gastroenterology group was 16.6% vs 1.2% (pz0.038). Of these, 40% had inadvertently accessed the pancreatic duct and a pancreatogram performed. Other complications included bleeding related to sphincterotomy, (nz1) in the gastroenterology cohort and gastric laceration, (nz1) in the surgical cohort. There were 3 deaths in the surgical cohort and 1 in the gastroenterology cohort. Of these, 3 were expected deaths due to cancer, 1 was related to PEP in the surgical cohort. The surgical cohort had more than double the LOS compared to gastroenterology (9.3 vs 4.1 days, pz0.002). Patients with PEP had a LOS (9 vs 1 day, pz 0.036) & patients with malignancy had twice the LOS compared to other indications (8.9 vs 4.7 days,pz0.046). Conclusions: In this study, ERCPs performed by surgeons had reduced technical success rates in biliary cannulation and higher rates of PEP as compared with gastroenterologists. This impacted on the length of stay and patient outcomes. Mo1435 Predictive Factors of Radiation Hazard Related With Endoscopic Retrograde Cholangiopancreatography Chi Hyuk Oh*, Seok Ho Dong Department of gastroenterology, Kyung Hee Univ. Hospital, Seoul, Korea (the Republic of) Background: Endoscopic retrograde cholangiopancreatography (ERCP) uses ionizing radiation in the form of fluoroscopy. Because fluoroscopy has positive relationship with radiation exposure, it makes a risk of radiation toxicity, for example malignancy. Many recently presented articles have a concern in relation to long-term toxicity of radiation. Aims: The aim of our study was to evaluation of radiation hazard during endoscopic retrograde cholangiopancreatography. Methods: We conducted a crosssectional retrospective analysis of the ERCP database results for a 3-years period. A retrospective analysis of 759 ERCPs performed by one expert endoscopist at the tertiary academic hospital during 3 years. We calculated the radiation dose in dose area product (DAP) units and correlated it with age, sex, body mass index, diagnosis, duration of procedure and procedure name. Results: As a result of analysis of the 759 ERCPs performed during the study period, the mean duration of procedures was 5.36 mins (95% CI, ). Mean radiation duration were as follows: CBD stones (nz411, 5.76 mins); malignant stenosis of bile duct (nz179, 5.78 mins); pancreatic disease (nz92, 5.28 mins); benign stenosis of bile duct (nz41, 5.32 mins); and periampullary stenosis (nz36, 4.89 mins). Multivariate analysis revealed that prolonged duration of procedure was related with specific factors of patient included age, BMI and diagnosis (all p!0.05). Among the parameters, body mass index was the most significant relation with radiation dose. In addition, the following three procedures made prolonged procedure duration: two more procedures performed during ERCP, metallic stent insertion and intra-bile duct biopsy (all p!0.05). Conclusions: ERCPs are associated with significantly higher radiation exposure to patients on the specific procedure. The endoscopists should be aware of the increased dose of radiation required when performing ERCP in patients with increased BMI, old age, and who has malignant stricture requiring metallic stent insertion. Mo1436 Fluoroscopy Dose and Time Characteristics During ERCP Mrinal S. Garg* 1, Pikul Patel 1, Margaret Blackwood 2, Satish Munigala 3, Elie Aoun 1, Abhijit Kulkarni 1, Manish K. Dhawan 1, Katie Farah 1, Shyam Thakkar 1 1 Department of Gastroenterology, Allegheny Health Network, Pittsburgh, PA; 2 Department of Radiation Safety, Allegheny Health Network, Pittsburgh, PA; 3 Department of Gastroenterology, Washington University, St. Louis, MO Purpose: Radiation exposure during endoscopic retrograde cholangiopancreatography (ERCP) is well documented; however, specific procedural data in relation to radiation usage is not well known. We evaluated the risk of radiation exposure from different indications and interventions using fluoroscopy dose and time. Methods: The study was a prospective analysis of 197 patients who underwent ERCP from January - July of 2013 at one tertiary care center endoscopy room. The fluoroscopy equipment used was a GE OEC TM 9800 C-arm. Patient characteristics (age and gender), anterior-posterior diameter (APD) and indications for ERCP were documented. ERCP interventions and characteristics such as procedural difficulty, use of magnification or high resolution images, and fellow involvement were recorded. Univariate and multivariate analyses were performed to determine ERCP indications, interventions, and characteristics predicting fluoroscopy time (FT) and fluoroscopy air kerma reference dose (FD). Results: After exclusions, 189 patients were included in the final analysis. Mean patient age was 62 (16.3) years and 52% were female. The mean FT was 307sec (95% CI 271.7, 342.5) per case and the mean FD was 16.5 centigray (95% CI 14.01, 18.99). On univariate analysis, the indication of common bile duct (CBD) stricture, interventions including dilation and the use of plastic stents, procedures that were moderately difficult and very difficult, and procedures that used magnification and high resolution images were all associated with longer FT (p!0.05) and higher FD (p! 0.05). When analyzed by multiple linear regression, the ERCP indication of CBD stricture, interventions including cholangioscopy, dilation, and the use of plastic stents, procedures that were moderately difficult and very difficult, and procedures that used magnification and high resolution images were associated with longer FT (p!0.05) (Table 1). ERCP indications of CBD stricture and pancreatic stricture, interventions including dilation, and procedures that were moderately or very difficult, and procedures that used magnification and high resolution images were also significantly associated with higher FD (p!0.05) (Table 2). Gastroenterology fellow involvement (68.3% of cases) did not significantly affect the FT (pz0.26) or FD (pz0.56). Conclusions: ERCP indications such as CBD stricture and pancreatic stricture as well as therapeutic interventions such as ductal AB418 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
24 dilation, cholangioscopy, and plastic stent placement were associated with higher radiation exposure. Furthermore, ERCP procedures that are moderately difficult, very difficult, involve magnification or high resolution images also lead to higher radiation exposure. Special care should be taken in these settings to minimize radiation exposure to both the patient and endoscopists. Table 1. Risk Factors for ERCP Radiation (Fluoroscopy Time) by Multivariate Analysis Parameter Estimate t-value p-value Indication CBD Stone CBD Stricture Pancreatic Stricture Cholangitis SOD Ampullary Neoplasm Procedure Balloon Sweep Sphincterotomy Dilation ! Cholangioscopy Plastic Stent Characteristic Moderately difficult ! Very difficult ! Magnification used Hires image taken CBD, common bile duct; SOD, Sphincter of Oddi dysfunction Table 2. Risk Factors for ERCP Radiation (Fluoroscopy Air Kerma Reference Dose) by Multivariate Analysis Parameter Estimate t-value p-value Indication CBD Stone CBD Stricture Pancreatic Stricture Cholangitis SOD Ampullary Neoplasm Procedure Balloon Sweep Sphincterotomy Dilation Cholangioscopy Plastic Stent Characteristic Moderately difficult ! Very difficult ! Magnification used Hires image taken CBD, common bile duct; SOD, Sphincter of Oddi dysfunction nz41,144) and 63.5 % (nz38,940) had a comorbidity index of at least 2. Most of the admissions were classified as emergent (64.5 %, nz34,600). The ERCP was usually performed at a large (67.7 %, nz 41,382), urban (93.1 %, nz56,889) hospital. The leading payer source was Medicare (91.7 %, nz 56,182). The mean length of stay was 7.1 days (SE 0.08) with an in-hospital mortality of 3.1 % (nz1,919). The primary discharge diagnosis was most often biliary stone disease (31.4 %, nz19,225). 45.0% (nz27,609) of patients had a diagnosis of any infection. Infection was associated with a significantly higher risk of in-hospital mortality (OR 2.8, 95% CI , p! 0.001). Conclusion: ERCP is now routinely being performed during inpatient admissions for octogenarians with diseases of the biliary tract. The mortality of octogenarians undergoing inpatient ERCP is higher than previous reports and is likely due to superimposed infection during the same admission. Mo1438 Needle Knife Precut Sphincterotomy Is a Safe Method in Elderly Patients Irfan Koruk*, Musa Aydinli, Cemil M. Savas, Mehmet Koruk Gastroenterology, Gaziantep University Medical School, Gaziantep, Turkey Introduction: Needle knife precut sphincterotomy (NKP) is one of the methods for difficult cannulation. The complication rate is higher in non-experienced hands. Also it is supposed to be higher in elderly patients. The aim of the study is to define if precut sphincterotomy is safe or not in elderly patients (over age 65). Aims&Methods: The aim of the study is to define if precut sphincterotomy is safe or not in elderly patients. 418 patients undergone ERCP in one-year period were evaluated. The same endoscopist did all the procedures. The demographic variables, total procedure time, cannulation technique, outcomes and complications were recorded prospectively. Results: Mean age of total 418 patients was (13-99) years. 132 of them (31.5%) were 65 years and older. Of these 132 elderly patients (56M/76F) mean age was years. 76 procedures (57.6%) were done for common bile duct stones, 23 (17.4%) for malignant disease, and remaining (25%) for other reasons. After attempts of standard cannulation techniques for 5 minutes if deep biliary cannulation is not achieved then NKP was applied. The NKP was started from the orifis to the top. In 103 of 132 patients (78%) ERCP was applied with standart techniques (ST). In 29 patients (22%) cannulation was achieved with NKP. Deep cannulation was achieved in 100/103 patients with ST and in all patients in the NKP group. Mean procedure time was minutes ( in ST and in NKP groups). There was one minor hemorrhage (no need for endoscopic therapy) and one pancreatitis in ST group and one cholangitis and no pancreatitis in NKP group. The overall complication rates were not statistically different (1.5 vs 3.4% respectively, pz0.249). Conclusion: NKP is an advanced cannulation technique. It has a long learning curve and is safe in experienced hands. Timing of the NKP is important and may play a role on post ERCP complications. Prolonged cannulation attempts may increase the complication rate. In this study we can conclude that with adequate timing and experience, needle knife precut sphincterotomy is a safe method in elderly patients. Mo1437 ERCP in Octogenarians: a Population Based Study Using the Nationwide Inpatient Sample Adam W. Coe* 3, Clancy J. Clark 1, Nora Fitzgerald 2, Rishi Pawa 3 1 General Surgery, Wake Forest Baptist Health, Winston Salem, NC; 2 Public Health Sciences, Wake Forest Baptist Health, Winston Salem, NC; 3 Gastroenterology, Wake Forest Baptist Health, Winston Salem, NC Background: In the elderly population, there is a growing demand for minimally invasive procedures as the incidence of pancreaticobiliary disease increases with age. Endoscopic Retrograde Cholangiopancreatography (ERCP) is now widely available and has proven utility in the management of biliary tract disease. Patients with advanced age offer unique challenges for any procedure as they also tend to have a higher rate of baseline comorbidities and malignancy. The aim of the current study was to characterize the mortality and length of stay of octogenarians undergoing inpatient ERCP. Methods: Using the Nationwide Inpatient Sample (NIS), we performed a retrospective analysis of health related outcomes among 80 to 89 year old patients undergoing inpatient ERCP. Surgical patients were excluded. Results: An estimated 61,322 octogenarians underwent inpatient ERCP in the United States from 2007 to The mean age was 84.2 (SE 0.02) with 59.5 % (nz36,460) of the patients being female. A large majority of the patients were Caucasian (79. %, Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB419
25 Mo1439 Safety and Efficacy of Moderate Sedation in Obese Patients Undergoing EndoScopic Retrograde Cholangiopancreatography for Suspected Choledocholithiasis Parit Mekaroonkamol*, Mehul Parikh, Ravi Vora, Stephen H. Berger, Emad S. Qayed Gastroenterology, Emory University, Atlanta, GA Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically demanding procedures in gastrointestinal endoscopy. It carries the highest complication rate of almost 5%. Most common indication for ERCP is suspected choledocholithiasis, a condition commonly affects obese patients, who are at increased risk of sedative complication. Propofol is preferred during elective ERCP as it can provide faster induction and shorter recovery time compared to conscious sedation. However, routine anesthesiologist-assisted deep sedation may not always be available or cost-effective. This study aims to evaluate the safety and efficacy of moderate sedation for obese patients undergoing ERCP for suspected choledocholithiasis.a retrospective case-control study evaluating all ERCPs performed for suspected choledocholithiasis during January 1 st 2011 and September 1 st 2014 in our institution was conducted. Out of a total of 63 ERCPs, 29 (46%) were performed for patients whose body mass index (BMI) was more than 30 with 10 (16%) procedures were performed for morbidly obese patients (BMI O 35). Majority of the population studied were African- American (86%) and female (90%) with a mean age of 36 years old. Among ERCPs for obese patients, 55% were performed using moderate sedation with fentanyl or meperidine and midazolam, while the other 45% were performed with general anesthesia. There was no direct correlation between increased BMI and selected method of sedation. There was no statistically significant difference in complication rate between two methods of sedation (odds ratio 0.14; 95% CI , p Z 0.22). No sedative-specific complications were observed in both groups. The technical success rate was lower in moderate sedation group (62.5%) compared to general anesthesia group (92%) however, this difference was not statistically significant (OR 7.2; 95% CI , p Z 0.08). Reasons for failure were inability to cannulate the duct (43%), inability to extract the stone (43%), and patient s intolerability to sedation (14%).Moderate sedation is a safe andviablemeanofsedationinobesepatients undergoing ERCP for suspected choledocholithiasis. However, despite its non-statistical significance, the lower success rate in moderate sedation group is concerning and larger prospective trials are warranted. We believe that inadequate sedation and patient s movement contributed to higher technical failure rate. Obesity alone cannot determine the proper method of sedation. Overall risk and complexity of the procedure need to also be taken into consideration. Mo1440 The Pure Endoscopic Drainage of Pancreatic Pseudocysts in Children - a Safe and Eficient Method - Case Series Marcel Tantau* 2,1, Alina Mandrutiu 1, Alina Tantau 2,3 1 Gastroenterology, Regional Institute of Gastroenterology and Hepatology Cluj Napoca, Cluj -Napoca, Romania; 2 Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania; 3 4rd Medical Clinic, Cluj-Napoca, Romania Background: Few data are available on the long term efficacy of endoscopic treatment in children with blunt pancreatic injuries. Aim: to evaluate the efficacy and long - term results of endoscopic drainage in pediatric patients with pancreatic pseudocysts at a tertiary care referral center. M&M: 4 children with pancreatic pseudocyst who underwent endoscopic drainage between September 2012 and October 2014 were retrospectively identified from the hospital database. Demographics data regarding the clinical history, the endoscopic procedures and the patients follow-up were collected from the medical charts and analyzed. All the patients were called to obtain updated clinical informations. Results: The etiology of pancreatic pseudocyst was blunt pancreatic trauma in all patients (#4 boys, mean age 8).All children were symptomatic, with abdominal pain and compressive symptoms (nausea, vomiting, early satiety).the pseudocyst were located in the pancreas body in 2 patients and in 2 patients in the pancreatic tail; the mean size mm.The procedures were performed under general anesthesia and radiology by the same endoscopist physician.in all patients were performed transgastric drainage with stenting (1-3 pigtail prosthesis) and in one case it was needed transpapilary drainage to, by the major and minor papilla sfincterotomy.in all cases the procedures were successful, none of patients underwent surgical drainage.mean follow-up after treatment is 10.5 months.all the patients had substantial improvement of symptoms after endoscopic treatment. The pseudocyst were successfully drained and did not reappeared during follow.up.the stents were endoscopically removed after the imaging examination had showed the pseudocysts resolution. Conclusions: Even though, our series of pediatric patients is not very large, we consider that the endoscopic treatment of pancreatic pseudocyst can be a safe and effective treatment with good results on long-term among children to. Mo1441 EUS-Guided Biliary Drainage: Single Center Study for the Assessment of Short and Long Term Outcomes Mouen Khashab*, Mohamad H. El Zein, Ahmed Abdelgelil, Vivek Kumbhari, Saowanee Ngamruengphong, Sepideh Besharati, Alan H. Tieu, Anthony N. Kalloo Johns Hopkins Medical Institute, Baltimore, MD Background: EUS-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical biliary drainage procedures after failed ERCP. Aims: To study 1) the safety and efficacy of EUS-BD at one U.S. center where all procedures were performed by one gastroenterologist in the endoscopy unit, 2) long term procedural-related outcomes and 2) predictors of complications. Methods: Consecutive jaundiced patients with malignant biliary obstruction who underwent EUS-BD after failed ERCP at one tertiary academic center between 2011 and 2014 were included. Follow-up consisted of monitoring for adverse events and repeat LFTs. Clinical success was defined as drop in bilirubin by 50% at 2 weeks or to below 3 (level that allows patients to undergo chemotherapy) at 4 weeks. Adverse events were graded according to the ASGE lexicon s severity grading system. Results: A total of 46 patients (age 61yrs, female 20, pancreatic cancer 30) underwent EUS-BD (Antegrade stenting 3, Rendezvous 6, choledochoduodenostomy 24, Hepatogastrostomy 12, Hepatojejunostomy 1) (Table 1). Reason for EUS-BD was obscured ampulla by invasive cancer or enteral stent (28), surgically altered anatomy (9), failed deep biliary cannulation (9). Most (nz44, 96%) patients had distal biliary strictures. Mean pre-procedural bilirubin was mg/dl. Electrocautery was used for biliary access and bilioenteric fistula dilation in only 4 (8.6%) cases. Cholangiography was successful in all 46 (100%) cases. Stent placement in desired location (technical success) was achieved in 40 (87%) cases (plastic stent 4 and metallic stent 36). A total of four patients were lost to follow-up. Clinical success was achieved in 34/36 (94.4%, intention to treat; 81% per protocol analysis). Bilirubin (mg/dl) decreased significantly after R 4 weeks (14.6 vs 1.41, p!0.0001). A total of 9 complications occurred in 9 (19.5%) patients: cholecystitis (nz1), cholangitis (nz3), peritonitis (nz1), biliary leak (nz3), and sepsis (nz1): 4 were graded as mild, 6 moderate, and 1 severe (cholecystitis). No predictors of complications were found. During long-term follow up, 25 (56.5%) patients died because of disease progression with patent stents after a mean of 165 days; 19 patients remain alive with patent stents at a mean follow up of 294 days. One patient experienced recurrent biliary obstruction due to incomplete stent expansion 2 days after stent deployment, and one patient experienced stent migration at 113 days. Conclusion: EUS-BD is an effective procedure after failed ERCP whether it is performed via intrahepatic or extrahepatic route. The approach should be individualized for each patient based on the endoscopist s experience and patient s anatomy. Adverse events are not uncommon but rarely severe. Devices tailored for EUS-BD are needed to improve the safety of the procedure. Table 1. Patient and procedural characteristics EUS-guided biliary drainage (n[46) Age, mean SD Female, n (%) 20 (43.4) Pancreatic Cancer, n (%) 30 (65.2) Stricture, n (%) Proximal 4 (8.7) Distal 42 (91.3) Reason for EGBD, n (%) Obstructed ampulla due to metallic 28 (61) enteral stent/invasive cancer Surgical upper GI anatomy 9 (19.5) Failed deep biliary cannulation 9 (19.5) Bilirubin, mean SD GOO, n (%) 8 (17.4) Intrahepatic access, n (%) 16 (34.7) Technique Antegrade 3 (6.5) Rendezvous 6 (13) CDS 24 (52.1) HG 12 (26) HJ 1 (2.1) Electrocautery, n (%) 4 (8.6) Type of stent, n (%) Plastic 4 (10) Metal 36 (90) Fully uncovered 3 (8.3) Partially covered 3 (8.3) Fully covered 30 (83.3) Cholangiography success, n (%) 46 (100) AB420 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
26 EUS-guided biliary drainage (n[46) Technical success, n (%) 40 (86.9) Clinical success, n (%) 34 (94.4) Reasons for clinical failure Rapid progression of liver metastases (1) Failed expansion of the stent due to tumor progression (1) Complication, n (%) 11 (23.9) Stent occlusion/migration, n (%) Obstructed 1(2.5) Migrated 1(2.5) Hospital stay, mean SD Mo1442 Endoscopic Ultrasound Guided Biliary Drainage Comes of Age: a Systematic Review and Meta-Analysis Muhammad Ali Khan*, Sobia Khan, Abdur R. Khan, Sehrish Kamal, Muhammad Imran Khan, Yaseen Alastal, Tariq A. Hammad, Ali Nawras University of Toledo, Toledo, OH Background: Endoscopic retrograde cholangiography (ERC) is considered a gold standard therapy for biliary stenting in palliation of malignant biliary strictures. Despite having a 90-95% success rate, ERC can be unsuccessful in cases of duodenal obstruction, surgically altered anatomy, periampullary tumor infiltration or periampullary diverticulum. In such cases, percutaneous transhepatic biliary drainage (PTBD) or surgical interventions can be performed. Endoscopic ultrasound (EUS) guided biliary drainage is being increasingly used at expert endoscopy centers to achieve satisfactory biliary drainage in malignant biliary strictures. Objective: A growing body of evidence, in the form of prospective and retrospective studies has compared the efficacy and safety of EUS guided biliary drainage as compared to PTBD. We present a meta-analysis of studies comparing the outcomes and adverse events between these two modalities for achieving biliary drainage. Methods: Several databases were searched from their inception to November 2014, which yielded a total of 757 citations. Three studies which compared the clinical efficacy and safety between EUS guided biliary drainage and PTBD were eligible for the analysis. The outcomes measured included events which were suggestive of clinical failure and number of adverse events. Mantel-Haenszel method was used to pool data in a random effects model. Odds Ratio (OR) and Risk difference (RD) analysis when studies reported no events in either arm were used to generate an overall effect estimate of both outcomes. Results: There was no significant difference in the efficacy of both the procedures for attaining satisfactory biliary drainage (RD -0.17[-0.43, 0.10] pz0.22 I 2 Z90%) but the safety profile of EUS guided biliary drainage was better than the percutaneous trans-hepatic biliary drainage (OR 0.17 [0.05, 0.62] pz I 2 Z 39%) (Figure A & figure B). The analysis was limited by associated heterogeneity between the studies. Conclusion: Our meta-analysis suggests that endoscopic ultrasound guided biliary drainage and percutaneous transhepatic biliary drainage are equally effective techniques for achieving adequate biliary drainage in malignant biliary strictures when ERC fails. However, current evidence reveals that EUS-BD is a relatively safer modality as compared to the standard PTBD. Mo1443 Endoscopic Ultrasound (EUS) -Directed Transgastric Endoscopic Retrograde Cholangiopancreatography (ERCP) in Roux EN Y Gastric Bypass: Internal or External Approach? Amy Tyberg 1, Prashant Kedia 2, Kristen R. Weaver 1, Monica Gaidhane 1, Reem Z. Sharaiha 1, Michel Kahaleh* 1 1 Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY; 2 Interventional Endoscopy, Methodist Dallas Medical Center, Dallas, TX Introduction: Patients with altered gastrointestinal anatomy and concurrent biliary pathology pose a therapeutic challenge. Deep-enteroscopy endoscopic retrograde cholangiopancreatography (DE-ERCP), laparoscopic-assisted ERCP, or percutaneous cholangiographyareassociatedwithlow successbuthighcomplicationrates. Wepresent our experience illustrating the safety and efficacy of using EUS to access the remnant stomach to facilitate ampullary access. This procedure was coined EUS-directed transgastric ERCP (EDGE). Methods: All patients underwent EDGE at our institution, using one of two procedural approaches. The first approach, external EDGE (E-EDGE), is performed in a two-stage procedure. In the first stage, a percutaneous endoscopic gastrostomy (PEG) tube is placed into the excluded stomach after insufflations via EUS; in the second stage, the PEG tube is removed, a transcutaneous fully-covered esophageal stent is deployed through the track, and conventional ERCP is performed through the stent. The second approach, internal EDGE (I-EDGE), is performed as an internal procedure. The excluded stomach is accessed using an EUS guided puncture from the gastric pouch, a fistulous tract is created, a fully-covered, lumen-apposing metal stent (LAMS) is deployed, and conventional ERCP is performed through the stent. Study outcomes were technical success, defined as successful gastrostomy creation, successful ERCP, and adverse events. Results: 11 patients underwent EDGE (mean age 54.4, 73% female). 6 patients underwent E-EDGE and 5 patients underwent I-EDGE. Technical success was achieved in 91% of patients (nz10). 100% of patients underwent conventional ERCP after gastrostomy creation. Average procedure time was 179.5min in E-EDGE group and 90min in the I-EDGE group (pz0.014). Average hospital stay was 6.5 days for both groups (pz0.93). Two patients in the E-EDGE group (40%) had an adverse event of PEG-site infection, treated with antibiotics. No post procedure adverse events were seen in the I-EDGE group, however 3 LAMS dislodgment were encountered and managed during the same procedure with LAMS reposition. No patients gained weight while the gastrostomy was in place (average weight change was kg in the E-EDGE group and kg in the I-EDGE group). Conclusion: EDGE in roux-en-y gastric bypass patients with biliary pathology in a single-stage (I-EDGE) or two-staged procedure (E-EDGE) is safe and efficacious with minimal adverse events. Technical success and adverse events were similar between the two techniques; however, internal EDGE involves a single-stage, minimally invasive procedure, and is associated with a shorter procedure time. Table 1. Clinical Information of Both Groups Internal EDGE n[5 External EDGE n[6 Statistical Significance Overall Technical Success 100% 83.3%* pz % Successful ERCP 100% 100% 100% Average min 90 min pz n/a Procedure Time Hospital Stay 6.4 days 6.5 days pz days Average Weight lbs lbs -2.2 lbs Change Adverse Events 0% 40% PEG-site infection, nz2 18% *PEG tube unable to placed endoscopically in 1 patient; placed by interventional radiology Figure A. Forest plot comparing the efficacy of EUS guided biliary drainage versus percutaneous trans-hepatic biliary drainage. B: Forest plot comparing the safety profile of EUS guided biliary drainage versus percutaneous transhepatic biliary drainage. Mo1444 Long Term Outcomes and Reintervention of EUS-Guided Biliary Drainage for Malignant Biliary Obstruction Yousuke Nakai* 1, Hiroyuki Isayama 1, Natsuyo Yamamoto 1, Saburo Matsubara 2, Yukiko Ito 3, Naoki Sasahira 4, Ryunosuke Hakuta 1, Kazunaga Ishigaki 1, Tsuyoshi Takeda 1, Dai Akiyama 1, Kaoru Takagi 1, Gyotane Umefune 3, Naminatsu Takahara 1, Tsuyoshi Hamada 1, Dai Mohri 1, Hirofumi Kogure 1, Minoru Tada 1, Kazuhiko Koike 1 1 Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 2 Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan; 3 Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan; 4 Gastroenterology, Tokyo Takanawa Hospital, Tokyo, Japan Background: Recently, EUS-guided biliary drainage (EUS-BD) for malignant biliary obstruction (MBO) is increasingly reported as a salvage technique in patients (pts) Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB421
27 with failed ERCP. Although technical success rate is high by an expert hand, its longterm outcomes are still unknown, and reinterventions for stent dysfunction or complications are not fully discussed. Patients: Pts undergoing EUS-BD, either hepaticogastrostomy (HGS) or choledochoduodenostomy (CDS), using a covered metal stent (CMS), were retrospectively studied. Data on stent dysfunction and other stent-related complications were extracted. Cumulative time to stent dysfunction was calculated by a Kaplan-Meier method. Reinterventions for stent dysfunction or other complications were also described. Results: Between Aug 2011 and Nov 2014, EUS-BD was performed in 46 pts (EUS-HGS in 33 and EUS-CDS in 13) at 4 affiliated hospitals. EUS-BD was performed as the initial drainage in 23 pts. The cause of MBO was pancreatic cancer in 26 pts, and the major reason for EUS-BD was gastric outlet obstruction (nz30). Stent dysfunction and other complications are summarized in Table 1. Stent dysfunction rate was 33% (15/46): 31% in CDS and 33% in HGS. A median time to stent dysfunction was 129 days in these 15 patients with stent dysfunction. The causes of stent dysfunction were migration in 5, hyperplasia at uncovered portion of HGS in 5, sludge/food impaction in 4 and bile duct kinking in 1. The median cumulative time to stent dysfunction was 229 days. Reinterventions performed via EUS-BD route were balloon sweep (nz3), additional stent (or nasobiliary drainage) placement (nz11) and additional antegrade stent placement (nz1). Trimming of a long-protruded HGS stent using APC was also performed in 4 pts to facilitate reinterventions through EUS-HGS stent. Biliary drainage was converted to transpapillary approach in other 2 pts. Percutaneous transhepatic biliary or gallbladder aspiration/drainage was performed for cholangitis and cholecystitis (nz5). Conclusions: Stent dysfunction in EUS-BD was not rare, but reinterventions via EUS-BD route was technically feasible using various ERCP-based techniques. Stent dysfunction, other related complications, and reinterventions Total (n [ 46) HGS (n [ 33) CDS (n [ 13) Reinterventions Dysfunction Migration Stent-in-stent by CMS 2, new CMS 1, conversion to transpapillary CMS 1, balloon sweep (patent choledochoduodenostomy) 1 Hyperplasia Stent-in-stent 5 (UMS 3, PS 2) Sludge/food impaction Balloon sweep 2, conversion to transpapillary stenting 1, temporary ENBD Stent-in-stent by UMS 1 Bile duct kinking Other complications Cholecystitis PTGBA 3, PTGBD 1 Abdominal N/A pain Bleeding Clipping 1, BTF 1 Stent Stent-in-stent in a tandem misplacement fashion by CMS 1 Segmental PTBD 1 cholangitis BTF; blood transfusion, CDS; choledochoduodenostomy, CMS; covered metal stent, ENBD; endoscopic nasobiliary drainage, HGS; hepaticogastrostomy, PS; plastic stent, PTBD; percutaneous transhepatic biliary drainage; PTGBA; percutaneous transhepatic gallbladder aspiration, PTGBD; percutaneous transhepatic gallbladder drainage, UMS; uncovered metal stent Mo1445 Safety and Efficacy of a Long, Partially-Covered Metal Stent for EUS-Hepaticogastrostomy in Patients With Malignant Biliary Obstruction Yousuke Nakai* 2, Hiroyuki Isayama 2, Natsuyo Yamamoto 2, Saburo Matsubara 1, Yukiko Ito 4, Naoki Sasahira 3, Ryunosuke Hakuta 2, Kazunaga Ishigaki 2, Tsuyoshi Takeda 2, Dai Akiyama 2, Kaoru Takagi 2, Gyotane Umefune 4, Naminatsu Takahara 2, Tsuyoshi Hamada 2, Dai Mohri 2, Hirofumi Kogure 2, Minoru Tada 2, Kazuhiko Koike 2 1 Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan; 2 Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 3 Gastroenterology, Tokyo Takanawa Hospital, Tokyo, Japan; 4 Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan Background: EUS-guided biliary drainage (EUS-BD) for malignant biliary obstruction (MBO) has been increasingly reported as an alternative to percutaneous transhepatic biliary drainage (PTBD) in failed ERCP, but commercially-available devices dedicated to the procedure are limited. While a covered metal stent (CMS) can reduce bile leak compared to a plastic stent, it can potentially increase the risk of migration as well as segmental cholangitis in EUS-guided hepaticogastrostomy (EUS-HGS). We aimed to evaluate safety and efficacy of a long, partially-cms (LP-CMS) for EUS-HGS. Patients: Consecutive patients (pts) undergoing EUS-HGS with a commercially-available LP-CMS (modified-giobor, 10-mm in diameter and 10- or 12-cm in length, 1-cm uncovered portion at the proximal end; TaeWoong Medical Inc.) were studied. EUS-HGS was performed as follows: Left intrahepatic bile duct was punctured using a 19G needle under EUS guidance. After contrast injection, a inch guidewire was inserted. The fistula was dilated by a coaxial electric cautery, biliary dilator and/or balloon, followed by stent insertion. The stent was deployed as the proximal end at B2/3 branch if possible. The primary outcome is technical success defined as stent placement at appropriate position and secondary outcomes are functional success and complications including stent dysfunction. Cumulative time to dysfunction was calculated by a Kaplan-Meier method. Results: Between Aug 2011 and Nov 2014, EUS-HGS using a LP-CMS was performed in 23 pts at 4 affiliated hospitals. The cause of MBO was pancreatic cancer in 12, and the reason for EUS-BD was gastric outlet obstruction in 19, altered anatomy in 3 and post-ercp pancreatitis in 1. Puncture was at B3 in 21, B2 in 1 and left hepatic duct in 1, and stent length was 10-cm in 15 and 12-cm in 8. EUS-HGS using a LP-CMS is technically successful in 100% with a median stent length of 49-mm in the stomach. The median procedure time was 45 min. Procedure-related (!24hr) complications are abdominal pain in 2, bleeding in 1 and segmental cholangitis (peripheral to HGS) in 1. Stent migration was noted only in a case with segmental cholangitis, whose stent migrated due to PTBD catheter manipulation for cholangitis. Stent dysfunction developed in 5 (22%): hyperplasia at uncovered portion in 4 and sludge in 1. A cumulative median time to dysfunction was 155 days. Conclusions: EUS-HGS using a LP-CMS for MBO was technically feasible and safe. A long protruded stent successfully prevented proximal migration and uncovered portion as an anchoring prevented distal migration, but hyperplasia at this portion can be a cause of recurrent biliary obstruction. Segmental cholangitis was rare even with a large bore (1-cm) CMS, but the appropriate length of uncovered portion, or the appropriate diameter of CMS for HGS should be further investigated. Mo1446 Endoscopic Ultrasound-Guided Rendezvous for Difficult Biliary Cannulation: a Multicenter Prospective Pilot Study Takuji Iwashita* 1, Ichiro Yasuda 1,2, Tsuyoshi Mukai 3, Keisuke Iwata 4, Nobuhiro Ando 4, Masanori Nakashima 3, Shinya Uemura 1, Masahito Shimizu 1 1 First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan; 2 Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan; 3 Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan; 4 Department of Gastroenterology, Gifu Prefectural General Hospital, Gifu, Japan Introduction: Biliary cannulation is indispensable step in therapeutic ERCP for biliary disorder. Although the reported success rate of biliary cannulation is high, there are still cases with difficult biliary cannulation. EUS guided rendezvous (EUS-RV) can salvage failed cannulation. Aims: To determine the safety and efficacy of EUS-RV with a standardized algorithm in terms of a scope position in a prospective cohort undergoing therapeutic ERCP. Methods: From August 2012 to October 2013, 674 patients with the naive papilla underwent therapeutic ERCP for biliary disorders at three tertiary-care centers. During this period, EUS-RV was attempted after failed biliary cannulation in 20 patients (3.0%). In the standardized approach, the extra-hepatic bile duct (EHBD) was initially tried to be accessed from the 2 nd portion of the duodenum (D2) under EUS-guidance using a 19-gauge FNA needle followed by either approaches to EHBD from the bulbs of the duodenum (D1) or intra-hepatic bile duct (IHBD) from the stomach according to operator s preference. After biliary puncture, a guidewire was placed antegradely into the duodenum through the needle and biliary duct. Finally the EUS was exchanged for a duodenoscope and biliary cannulation was achieved over or adjacent to the guidewire. Result: 20 patients [median age, 76yo (range 49-84); 6 females] underwent salvage EUS-RV for obstructive jaundice (13) and cholangitis (7). Cannulation failed due to cancer infiltration (7), peri-ampullary diverticulum (1), duodenal stricture (1) or other technical reasons (11). The bile duct was accessed via EHBD from D2 (10), but D1 (5) and stomach (4) due to no dilation of distal EHBD (6) and tumor invasion in distal EHBD (3). In the remaining one patient with chronic pancreatitis, the biliary puncture was failed due to collateral vessels. The guidewire placement into duodenum was obtained in 80% (16/20): 100% (10/10) with D2 approach and 56% (5/9) with other approaches. Biliary cannulation was achieved in 80% (16/20) followed by proper therapy. The patients with failed EUS- RV were salvaged with PTCD (2), repeat ERCP (1), and conservative management (1). Complications in 3 patients (15%) incluldind mild pancreatitis (2) and liver hematoma (1) and were successfully managed conservatively. Conclusion: EUS-RV is safe and effective salvage technique after failed biliary cannulation. EUS-RV with D2 approach showed tendency for higher success rate, although D2 access was possible in only 50% of patients. AB422 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
28 Mo1447 A Prospective Multicenter Study of EUS-Guided Choledochoduodenostomy Using a Covered Metallic Stent As a Primary Biliary Drainage in Unresectable Malignant Biliary Obstruction Yousuke Nakai* 1, Hiroyuki Isayama 1, Hiroshi Kawakami 2, Hirotoshi Ishiwatari 3, Masayuki Kitano 4, Yukiko Ito 5, Ichiro Yasuda 6, Hironari Kato 7, Saburo Matsubara 8, Atsushi Irisawa 9, Takao Itoi 10, Masaki Kuwatani 2, Michihiro Ono 3, Hajime Imai 4, Takuji Iwashita 6, Goro Shibukawa 9, Takayoshi Tsuchiya 10 1 Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 2 Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan; 3 Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan; 4 Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-Sayama, Japan; 5 Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan; 6 First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan; 7 Gastroenterology and Hepatology, Okayama University Graduate School of Medicine and Dentistry, Okayama, Japan; 8 Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan; 9 Gastroenterology, Fukushima Medical University Aizu Medical Center, Aizuwakamatsu, Japan; 10 Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan Background: EUS-guided biliary drainage (EUS-BD) for unresectable malignant biliary obstruction (MBO) is increasingly reported as a salve technique in failed ERCP. EUS-BD can theoretically avoid post-ercp pancreatitis and provide longer stent patency by bypassing the ampulla and the biliary stricture from the tumor, but only a few prospective studies in a single center have been reported to evaluate its role as a primary biliary drainage. Our multicenter retrospective study of 64 cases who underwent EUS-BD at 7 institutions demonstrated a high technical success of 95% with an acceptable complication rate of 19% (J Hepatobiliary Pancreat Sci. 2014;21:328). EUS-CDS with a covered metal stent (CMS) showed even lower complication rate of 12%. Therefore, we conducted this multicenter, prospective study of EUS-guided choledochoduodenostomy (EUS-CDS) with a CMS as a primary biliary drainage for unresectable distal MBO. Methods: Patients (pts) with obstructive jaundice due to unresectable distal MBO without any prior drainage are enrolled. Exclusion criteria were surgically-altered gastrointestinal anatomy, presence of ascites, poor visualization on EUS, severe coagulopathy and sever comorbidity. After a detailed discussion with pts, full written informed consent was obtained. EUS-CDS was performed using a CMS (Wallflex, Boston Scientific corp.; 8 or 10 mm in diameter, 4, 6 or 8 cm in length). Primary endpoint was defined as technical success and secondary endpoints as adverse events, functional success, and stent dysfunction. A cumulative time to stent dysfunction was calculated using a Kaplan-Meier method. Results: A total of 34 pts were enrolled in 10 Japanese institutions between Feb 2013 and May Primary tumor was pancreatic in 28 pts. Median tumor size and stricture length was 31 and 13 mm, respectively. Technical success rate was 97% with a median procedure time of 26 min. One case received a plastic stent placement due to failed insertion of the delivery system of CMS into the bile duct. Functional success rate was 100%. Complications within 48 hrs of the procedure were abdominal pain in 9%, cholecystitis in 3%, and cholangitis in 3%. Late (O48 hrs) stent-related complications were cholecystitis in 6%. Stent dysfunction rate was 36% and all stent dysfunction was non-tumor related: migration in 18% and cholangitis in 18%. A median cumulative time to stent dysfunction was 8.9 months. No pancreatitis or bile peritonitis was observed in this study. Conclusion: EUS-CDS using a CMS as a primary biliary drainage for unresectable distal MBO was technically feasible and its safety appeared comparable to, or even better (no pancreatitis) than transpapillary stenting by avoiding post-ercp pancreatitis. A randomized controlled trial of EUS-CDS vs. transpapillary stenting is warranted. Mo1448 EUS-Guided Biliary Drainage: a Single Center Experience Hakan Senturk*, Birol Baysal, Omar Masri, Yusuf Kayar, Mukaddes Tozlu, Ali T. Ince, Ahmet Danalioglu Bezmialem University, Faculty of Medicine, Department of Gastroenterology, Istanbul, Turkey Background: Failure of biliary access and drainage during ERCP is reported in 5-10% of cases due to anatomic or technical difficulties. EUS-guided biliary drainage (EUS- BD) techniques have been suggested and developed to replace percutaneous or surgical approaches. Aim: The aim of this study was to assess the efficacy and safety of EUS-BD in a single tertiary center. Methods: Patients referred for EUS-BD at Bezmialem Vakif University in Istanbul between the period from April 2011 and November 2014 were retrospectively identified. Patients were classified according to the approach used: Hepatico-gastrostomy (HGS), Choledocho-duodenostomy (CDS), or the Choledochal-Rendez-vous (C-RV) technique. Data were collected including baseline characteristics, indications, techniques, success rates and complications. Results: During the stated period, a total of 34 patients were referred for EUS-guided biliary drainage. HGS, CDS and C-RV were attempted in 19, 6 and 9 patients respectively. The overall technical success rate was 76.5%, being 94.7% (18 patients) with HGS, 50% (3 patients) with CDS, and 55.6% (5 patients) with the C- RV. The most common indication was an inoperable pancreatic cancer (50.0%). A total of 15 complications occurred. Two procedure related mortalities occurred: one due to massive bleeding and one due to anesthesia related respiratory arrest. One case of accidental guidewire knotting in the duodenum was encountered. Only one major complication and no mortalities occurred after performing the first 19 procedures. Conclusion: Although associated with considerable risk of complications, EUS-guided biliary drainage remains an effective alternative to percutaneous or surgical approaches particularly in terminally ill patients. It should be performed in expert centers only. The HGS success rates were the highest in this series. Comparative studies are needed. Demographic Features, Indications and Success Rates of the Patients HGS CDS C-RV Total N M:F 14:5 4:2 5:4 23:11 Age (range) 65.7 (37-87) 63.3 (56-81) 70.7 (62-80) 66.6 (37-87) Indication Pancreatic cancer Cholangiocarcinoma Periampullary tumor CBD Stones Proximal obstruction* Benign stricture Reason for EUS-BD Surgical diversion Luminal obstruction Deformed ampulla Failed ERCP Obstructed stents Diverticulum Type of stent Plastic 2 1 ND** (3) 6 Metallic 17 (3 PC) 2 ND** (1) 20 Technical success 94.7% (18/19) 50% (3/6) 55.6% (5/9) 76.5% (26/34) rate, % (n/n) Complications, n (%) 9 (47.4%) 4 (66.7%) 2 (22.2%) 15 (44.1%) Mortality, n (%) (5.9%) *Lesions were: Intrahepatic communicating abscess, Compressing GB cancer and extensive metastasis. **Stents were not always needed in patients with C-RV Mo1449 Conversion to EUS-Guided Biliary Drainage by Temporary Nasobiliary Drainage Placement in Patients With Prior Biliary Stenting for Malignant Biliary Obstruction Yousuke Nakai* 1, Hiroyuki Isayama 1, Natsuyo Yamamoto 1, Saburo Matsubara 1,2, Yukiko Ito 3, Naoki Sasahira 4, Kazunaga Ishigaki 1, Ryunosuke Hakuta 1, Tsuyoshi Takeda 1, Dai Akiyama 1, Kaoru Takagi 1, Gyotane Umefune 3, Naminatsu Takahara 1, Tsuyoshi Hamada 1, Dai Mohri 1, Hirofumi Kogure 1, Minoru Tada 1, Kazuhiko Koike 1 1 Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 2 Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan; 3 Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan; 4 Tokyo Takanawa Hospital, Tokyo, Japan Background: Gastric outlet obstruction (GOO), one of the reasons for failed ERCP, is often coexistent with or preceded by malignant biliary obstruction (MBO). Although combined duodenal and transpapillary biliary stenting has been reported, transpapillary approach is technically difficult with an indwelling duodenal stent and conversion to EUS-guided biliary drainage (EUS-BD) can be an alternative (Dig Dis Sci 59:1931). On conversion to EUS-BD, leak of contaminated bile due to prior transpapillary drainage can potentially cause severe peritonitis and bile duct dilation can be only minimal when the indwelling stent is incompletely occluded. A temporary nasobiliary (NB) drainage can reduce risk of peritonitis by reducing bacterial load in the bile as well as facilitate bile duct puncture by contrast injection. Herein, we evaluated feasibility and safety of conversion to EUS-BD using a temporary NB tube in patients (pts) with prior transpapillary or trans-bilioenteric anastomosis (BEA) biliary stenting. Patients: Pts undergoing conversion to EUS-BD using a NB tube were retrospectively studied. Procedure was performed as follows: When ERCP as reintervention for a transpapillary or trans-bea stent was performed, an indwelling biliary stent was exchanged to a temporary NB tube. After resolution of cholangitis, EUS-BD was performed. Contrast was injected through the NB tube and puncture by Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB423
29 a FNA needle, followed by guidewire insertion, was performed under both EUS and fluoroscopy guidance. After fistula dilation, a covered metal stent (CMS) was then placed. Primary endpoint is technical success, and secondary endpoint is safety. Results: Between Aug 2011 and Nov 2014, conversion to EUS-BD after NB tube placement was attempted in 16 pts: hepaticogastrostomy in 14 and choledochoduodenostomy in 2. Primary cancer was pancreatic in 9. Prior drainage was transpapillary in 14 and trans-bea in 2: CMS in 10, plastic stent (PS) in 3, ENBD in 1 for distal MBO (nz14), and PS through an occluded uncovered metal stent in 1 and ENBD in 1 for hilar MBO (nz2). The reason for conversion to EUS-BD was GOO in 12, recurrent cholangitis in 2 (due to tumor bleeding in 1 and sludge in 1), difficult enteroscopy-assisted ERCP in 1 and post-ercp pancreatitis in 1. A NB tube placement and subsequent conversion to EUS-BD (puncture, guidewire insertion, fistula dilation and stent placement) were successful in all 16 pts. Procedure-related complications were 1 cholecystitis, 1 bleeding and 1 segmental cholangitis. No peritonitis or sepsis was observed. Conclusion: Conversion to EUS-BD by temporary NB tube placement was technically feasible and safe in pts with prior biliary stenting for unresectable MBO. This procedure should be considered when EUS-BD is attempted in cases with cholangitis due to prior stent dysfunction or in cases with minimal biliary dilation. Mo1450 Is Ascites a Contra-Indication to Endoscopic Ultrasound-Guided Biliary Drainage in Case of Unsuccessful ERCP?: Results of a Pilot Study Olivia B. Luna, Ines Oria, Fabien Fumex, Julien Marsot, Christine Lefort, DrVincent Lépilliez,, DrJulien Balique,, DrRaphael Bourdariat, DrSingier Gaetan,Bertrand Napoleon* Hopital Prive Jean Mermoz, Lyon, France Introduction: In case of malignant obstruction of the bile duct with failure of endoscopic retrograde cholangiography (ERCP), a percutaneous trans-hepatic biliary drainage (PTBD) is usually done. One contra-indication of this procedure is the presence of ascites. Endoscopic ultrasound-guided biliary drainage (EUS-BD) could be a solution but it has never been evaluated in this situation. The objective of this single-center study is to determine whether ascites is a contra-indication for EUS-BD. Methods: Between July 2010 and July 2014 all patients with a biliary EUS- BD done for an ERCP failure were prospectively included in a database. Drainage was performed by choledocoduodenostomy (CD) or hepaticogastrostomy (HG) depending on the localization of the stenosis. Routine antibiotic prophylaxis was given. Systematic bile samples for bateriology were performed at the time of puncture of the bile ducts. In October 2014 a retrospective analysis was performed in patients with obstructive tumor by comparing those with ascites (group 1) to those without ascites (group 2). The technical and clinical success, complications and follow-up until death were compared between the two groups. Results: Thirtyone patients were included. In group 1 (n Z 11 / 5CD, 6HG) technical success was achieved in 10/11 cases. One early complication was observed (migration of the stent) requiring emergency surgery to reposition the stent. Clinical success was achieved in 7/10 patients. 4 patients died during the first month. In one case the death could have been related to the procedure (septic shock). Bacteriology of the biliary fluid was positive twice (22% of cases). One of these patients had pneumoniae with the same bacteria. All patients died of disease progression (mean survival 78 days (10-333)). In group 2 (n Z 20 / 8CD, 12HG) technical success was achieved in 17/20 cases.three early complications were noted (1 perforation treated by clip, 1 bile peritonitis, 1 bleeding). Clinical success was noted in 16/17 cases. Bacteriology of the biliary fluid was positive in four cases (20% of cases). One patient had a cholangitis following the procedure. 14 patients died of disease progression (mean 115 days (7-299), 6 are alive (mean 300 days ( )). Conclusions: This study shows that we can achieve a EUS-BD with good technical efficacy in patients with peritoneal carcinomatosis and ascites. The risk of infection remains limited (22% of patients) and comparable to patients without ascites. These results suggest a prospective multicenter study. Mo1451 Efficacy of EUS-Guided Antegrade Transpapillary Stenting in Case of Failed ERCP: Retrospective Analysis in Two Large Volume Centres Vinay K. Dhir* 1, Takao Itoi 2, Suryaprakash Bhandari 1, Mukta Bapat 1, Nitin Joshi 1, Amit P. Maydeo 1 1 Endoscpy, Baldota Institute of digestive sciences, Mumbai, India; 2 Tokyo Medical University, Tokyo, Japan Background: EUS-guided biliary drainage (EUS-BD) has evolved as a viable alternative for biliary drainage. Published studies about EUS-BD have shown a lower rate of post procedure pancreatitis, presumably due to bile duct access being away from papilla. EUS-guided antegrade transpapillary stenting resembles ERCP or PTBD as the stent exits through papilla, and not trans-luminally. There are no major published studies of EUS-AGAims: To assess safety and efficacy of EUS-AG for biliary drainagesetting: Two tertiary care centrespatients: Patients with obstructive jaundice and failed ERCP or ERCP is not possiblestudy design: Retrospective analysis. Methods: Left hepatic duct puncture was done from proximal stomach using a 19 gauge needle. Guidewire was manipulated across the hilum, and papilla in to duodenum. After track dilation with a biliary balloon or a cystotome, a stent was inserted and positioned across the papilla Results: There were 56 patients (median age 65 years, 24 females). Fifty four patients had a malignant distal obstruction ( pancreatic 50, ampullary 3, bile duct 1), and two had a proximal obstruction (bile duct 1, nodal 1). Twenty one patients (37.5%) had normal duodenum, 26(41%), had duodenal stenosis, while 9(16%) had post operative anatomy( Whipples 6, Billroth II 2, total gastrectomy 1). The mean pre-procedure bilirubin was 14.6 mg%. Technical success was achieved in 53 patients (94.64%). Expandable metal stents were placed in 49 patients while 4 patients had plastic stents. Six patients (10.71%) developed 8 adverse events (14.28%). Adverse events were highest in the prior surgery group (2/9, 22.2%, followed by those with duodenal stenosis (3/26, 11.53%, and normal duodenum (1/21, 4.3%). The difference however was not statistically significant (pz0.6). Adverse events included pancreatitis in 2 (3.57%),bleeding in 2 (3.57%) and cholangitis, perforation, and stent migration in one patient each(1.78%). There was no mortality. Both the patients with pancreatitis had not undergone a prior ERCP. One patient developed mild, and another moderate pancreatitis. Over a median follow up of 280 days, 3 patients (5.6%) had partial stent migrations, while stent block developed in 14 patients (26.41%).Sixteen patients(30.1%) died with stent in situ. Kaplan-Meier curves for stent patency show that median stent patency was O210 days(figure 1). Conclusions: EUS-AG procedure has safety and efficacy profile similar to other EUS- BD procedures. However the post-procedure pancreatitis rates appear higher, and are equivalent to those reported for ERCP. This could be due to papillary manipulation during antegrade stent placement. Prospective study compared with conventional ERCP is warranted. Mo1452 Use of a Single-Step Lumen-Apposing Covered Metal Stent Delivery System Can Decrease the Cost of Pancreatic Cyst Drainage Andres Sanchez-Yague* 1,2, Angel Gonzalez Canoniga 1,2, Cristina Lopez Muñoz 1, Andres Sanchez Cantos 1, Roy M. Soetikno 3 1 Gastroenterlogy Dept, Hospital Costa del Sol, Marbella, Spain; 2 Gastroenterology Dept, Vithas Xanit International Hospital, Benalmadena, Spain; 3 Gastroenterology Dept, VA Palo Alto Health Care System, Palo Alto, CA Introduction: Endoscopic ultrasound (EUS) guided drainage of symptomatic pancreatic collections has largely replaced surgical approaches. The classic strategy (CS) of drainage requires several steps: access to the collection using a needle, dilatation of the tract and placement of several plastic stents. A new strategy utilizes a single-step procedure (SSP) using a device, which combines a cautery-tip and a lumen apposing covered metal stent (LA-CMS) delivery system. LA-CMS potentially decreases the procedure time and facilitates necrosectomy by making it unnecessary to repeatedly remove the plastic stents, dilate the tract and insert new stents over time. We aimed to compare the cost differential between the two strategies. Material and Methods: We performed a cost analysis using available data from our prospectively collected database from 2008 to 2014 to. We calculated the differential cost, by calculating the time and cost of accessories during the drainage and necrosectomy. The time starts from the moment of puncture of the collection to complete deployment of the last stent, and, for the necrosectomy session, includes the time from the removal of the first stent to reinsertion of the scope to perform necrosectomy plus the time from the insertion of the guidewire to deployment of the last stent. As the LA-CMS maintains a patent lumen no time was considered in SSP. Indirect and material costs for the initial and necrosectomy sessions, depending on the strategy, are shown on table 1. We analyzed the hospital length of stay. Statistical analysis chi-square for AB424 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
30 qualitative measures and U-Mann Whitney for quantitative measures Results: A total 24 consecutive procedures, 12 in each group, were included. The SSP required significantly less time to complete (mean 5513 seconds) as compared to that of CS (mean sec; p!0.0001). The cost of the initial procedure was significantly higher the SSP group ( V; p!0.0001) than in the CS ( V). Necrosectomy was performed in 7 patients of the CS group (mean sessions; range 1-4) and 10 of the SSP group (mean sessions; range 1-4; pz0.033). The accumulated cost for the accessories of repeated necrosectomy was lower in the SSP group (fixed cost V; p!0.0001) as compared to that in the CS group (mean V; range V V). There were no differences in the number or total time of hospitalization between the two groups. Conclusions: A single-step LA-CMS placement procedure significantly decreases initial procedure time and facilitates necrosectomy sessions. The cost of LA-CMS is offset by the cost of additional accessories used for necrosectomy sessions in the classic strategy. Placement of a LA-CMS using a single-step procedure should be considered if necrosectomy is anticipated. Table 1. Direct and indirect costs Classic Strategy (CS) Single-Step Procedure (SSP) Concept Cost Concept Cost Indirect costs Staff, OR and nonspecific materials 0.078V per second Staff, OR and nonspecific materials 0.078V per second Initial procedure Necrosectomy session 19G needle, guidewire, dilatation balloon, pushing catheter and 3 pigtails stents snare, dilatation balloon, guidewire, catheter and 2 pigtail stents snare, dilatation balloon, guidewire, catheter and 3 pigtail stents Table 2. Comparison of strategies 1037V Device, combinig a cautery-tip and LA- CMS delivery system (HotAXIOSä) 1800V 816,8V No material 0V 914,8V Classic strategy (CS) Single-step procedure (SSP) n n.s Mean age (yrs) Gender (m/f) 7/5 12/ Mean PC size Mean initial procedure differential cost (V) p! (favours CS) Necrosectomy Mean number of sessions pz0.033 (favours SSP) Range of necrosectomy session differential cost (V) not applicable Mean accumulated necrosectomy session differential cost (V) p! (favours SSP) Mo1453 Postoperative Abdominal Collections Drainage: Percutaneous Versus Guided by Endoscopic Ultrasound Felix I. Tellez-Avila*, Guillermo Carmona-Aguilera, Francisco Valdovinos-Andraca, Angela Saúl, Javier Elizondo-Rivera, Enrique Murcio-Perez, Miguel A. Ramirez Gastrointestinal Endoscopy, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico Background and Aim: Postoperative fluid collections (POFC) have high mortality. Surgical drains are associated with a high mortality rate about 20-40%. Percutaneous drainage (PD) is the tool of choice, with a success rate of %, and mortality of %. The drainage guided by endoscopic ultrasound (EUS-GD) represents a good option but there are still limited data. The aim was to compare clinical success and complication rate of EUS-GD vs percutaneous approach. p Material and Methods: Data collected prospectively were analyzed in a retrospective manner. Patients with POFCs from October 2008 to November 2013 were included. All collections were drained percutaneous or EUS-GD. Results: 63 procedures in 43 patients with POFC were analyzed, 13 patients were EUS-GD group and 32 patients with PD. Two patients assigned initially to PD group were crossed to EUS-GD. There were 26 (60.4%) men and 17 (39.6%) women with a mean SD age of years. The surgery procedures more often related to collections were: intestinal reconnection, distal pancreatectomy, biliary-digestive bypass, and exploratory laparotomy. The technical success, clinical success, recurrence, hospital stay, complications and mortality in the groups are shown in table 1. In PD group one death was related with procedure. Conclusions: EUS-GD is as effective and safe as PD in patients with POFCs with the advantage of not requiring an external drainage and a trend of higher clinical success and less hospital stay could be considered. Table 1. Differences in outcome measures in the EUS-GD and PD groups EUS-GD n [ 13 n (%) Percutanous Drainage n [ 32 n (%) Value P Technical success 13 (100) 29 (90.6) 0.25 Clinical success 3 (100) 27 (84.4) 0.13 Recurrence 4 (30.7) 8 (25) 0.69 Hospital stay, days 22 (8-61) 26.5 (8-99) 0.35 Need for surgery 3 (23) 3 (9.3) 0.25 Complications 0 (0) 2 (6.25) 0.3 Mortality 1 (7.6) 2 (6.25) 0.9 EUS-GD: drainage guided by endoscopic ultrasound; PD: percutaneous drainage Mo1454 Novel Applications for Lumen Apposing Metal Stents: How Far Can WE Go? Reem Z. Sharaiha 1, Amy Tyberg 1, Amit P. Desai 1, Petros C. Benias 2, Vivek Kumbhari 3, Christopher J. Dimaio 4, Divyesh V. Sejpal 5, Amrita Sethi 6, Sammy Ho 7, Alan H. Tieu 3, Monica Gaidhane 1, Mouen Khashab 3, David L. Carr-Locke 8, Michel Kahaleh* 1 1 Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY; 2 Gastroenterology, Beth Israel, New York, NY; 3 Advanced Endoscopy, John Hopkins Medicine, Baltimore, MD; 4 Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY; 5 Division of Gastroenterology & Hepatology, Hofstra North Shore-LIJ School of Medicine, North Shore-LIJ Health System, New York, NY; 6 Division of Gastroenterology, Columbia University Medical Center, New York, NY; 7 Gastroenterology, Montefiore Medical Center, Bronx, NY; 8 Gastroenterology, Mount Sinai Beth Israel Medical Center, New York, NY Introduction: A lumen apposing metal stent (LAMS) has recently received FDA clearance for the drainage of pancreatic fluid collections. However, published case reports have shown its efficacy and safety in a variety of other applications. These include endoscopic-ultrasound guided gallbladder and biliary drainage, creation of gastrointestinal bypass for luminal obstruction, and access to the ampulla in patients with altered gastrointestinal anatomy. Methods: A retrospective review of all patients who underwent LAMS (Axios; XLumena, Moutainview, Ca) placement at six academic centers in the United States was conducted between January 2014 and November All data was extracted and compiled into a central database. Demographics, clinical history, procedural details, and post-procedural follow-up were recorded. Technical success and immediate and long-term adverse events were documented for each case. Results: 26 patients were included (12 males, mean age 64.6 years). The indications for using the lumen opposing stent included luminal obstruction (19.2%, nz5), altered anatomy (26.9%, nz7), gallbladder drainage (30.8%, nz8) and biliary obstruction (23.1%, nz6). In patients with luminal obstruction, the LAMS was placed jejuno-jejunal (nz1), percutaneous-gastric (nz1), or gastro-jejunal (nz3). Technical success was achieved in 96.2 % (nz25) of patients. There was one adverse event (3.85%) which was peri-procedural bleeding, managed endoscopically. No long-term adverse events occurred. For the patients with luminal obstruction, no patient subsequently required surgery and 100% of patients were tolerating an oral diet on follow-up. For the patients with altered anatomy, conventional ERCP could be performed through the stent in 100% of patients. For gallbladder drainage and biliary obstruction, no patient required further procedures for decompression with normalization of their LFTs. Conclusion: LAMS placement is technically feasible and obviates the need for more invasive procedures. In high-risk operative patients or in patients unwilling to undergo percutaneous intervention, LAMS provides a safe, efficacious and minimally invasive, endoscopic alternative. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB425
31 Table 1. Clinical Information Technical Success Adverse Events Clinical Resolution Luminal Obstruction Jejuno-jejunal, n[1 Percutaneousgastric, n[1 Gastro-jejunal, n [3 n[5 Gallbladder Drainage n[8 Biliary Obstruction n[6 Ampullary Access in Altered Anatomy n[7 Overall n[26 100% 100% 83.3% 100% 96.2% None None Bleeding* nz1 100% 100%** 100% Avoided Surgical Avoided Avoided Intervention Surgical Additional Tolerating PO Intervention Intervention Diet Normalization Normalization of LFTs of LFTs *Managed endoscopically **1 patient had withdrawal of care post-procedure None 3.85% 100% Underwent Conventional ERCP 100% Mo1455 WOPN Drainage With Bfms: Clinical Outcome Is Determined According to the Amount of Debris Sundeep Lakhtakia* 2, Mohan Ramchandani 2, Domenico Galasso 1, Rajesh Gupta 2, Rakesh Kalapala 2, Tin M. Wai 2, Manu Tandan 2, Todd H. Baron 3, Nageshwar D. Reddy 2 1 Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Rome, Italy; 2 Gastroenterology and Therapeutic Endoscopy Department, Asian Institute of Gastroenterology, Hyderabad, India; 3 Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC Background: Endoscopic drainage of walled off pancreatic necrosis (WOPN) usually requires a large transmural tract and placement of multiple stents and/or insertion of a naso-cystic irrigation tube to remove solid debris. We report our experience using a large bore fully covered biflanged self expandable metal stent (BFMS) in draining WOPN stratified according to degree of solid debris: less than 1/3 (group A); between 1/3 and 1/2 (group B); and more than 1/2 of content debris (group C). Objective: To evaluate safety, technical success rate and clinical outcome using a BFMS for drainage of WOPN based on the amount of underlying debris.design: Retrospective case series.setting: High volume tertiary care academic center.patients: Thirty-five patients (31 male; median age 32 years, range years) presenting with symptomatic WOPN who underwent endoscopic drainage using a BFMS.Intervention: Cyst-enterostomy was performed under endoscopic ultrasonography (EUS) guidance. The BFMS diameter was 12mm in 3 patients, 14mm in 31 patients and 16mm in 1 patient. SEMS removal was intended 8 weeks after insertion.main Outcome Measurements: Technical and clinical success rates and adverse events (AEs). Results: SEMS was successfully deployed in all 35 patients (100% technical success) over a period of 11 months. Median size of WOPN at initial EUS evaluation was 107x86mm (range 53x38mm to 160x117mm). Overall clinical success, without need for additional interventions was achieved in 29/35 (83%) patients: 20/ 23 (87%) in group A, 5/6 (83%) in group B and 4/6 (66%) in group C. Overall AEs within 1 month after drainage occurred in 7/35 (20%) patients: 3/23 (13%) in group A; 1/6 (17%) in group B; and 3/6 (50%) in group C. No recurrence of symptoms in 31 patients was detected at last follow-up after a median of 13 months (range 8-18 months).limitations: Lack of a validated method for debris amount measurement. Retrospective, single-centre experience and lack of comparative arm. No crosssectional imaging studies to determine asymptomatic recurrence. Conclusions: Endoscopic therapy using a BFMS with bilateral anchor flanges is safe and effective in 83% of WOPN. The quantity of debris in WOPN relates to difference in clinical success and AEs occurrence. Further studies are needed to validate these findings and compare SEMS to plastic stents. Mo1456 Lumen Apposing Metal Stents: Experience and Technical Aspects in a Terciary Hospital Irene Peñas*, Carlos De La Serna, Fernando Santos Santamarta, Ramon Sanchez-Ocana, Victoria Busto Bea, Loza Luz Andrea, Rebeca Amo Alonso, Manuel Perez-Miranda Hospital Universitario Río Hortega, Valladolid, Spain Introduction: Experimental and preliminary clinical data on EUS-guided drainage oranastomosis procedures using lumen apposing metal stents (LAMS) are encouraging.lams, however are only approved for pancreatic fluid collections (PFC). Clinical data forother indications are limited. We aimed to characterize the full clinical spectrum of currentlams use and report technical and short-term clinical outcomes with EUS-guided LAMSplacement, through-the-stent endoscopy (TTSE) & removal Methods: Prospectively databased patients with LAMS (AxiosÔ, Mountain View, CA) placementbetween May 2011 to November 2014 were reviewed. Indications were grouped into PFC,non-pancreatic fluid collections (NPFC), gallbladder, bile-duct and small bowel. LAMS Type(Hot Z cautery tipped Vs Cold) & Diameter, Technical difficulties during placement orremoval, ancillary interventions (coaxial pigtail or drain, TTSE), intraprcceduralcompications were retrieved from reports. Clinical outcomes were obtained by recordreview, outpatient clinica and/or phone contact. Results: 136 patients (meanz 69.5 (SD 16.5) years old, 67% male) underwent attempted LAMSplacement. Most frequent indications (Table) were PFC (nz73, 46% pseudocyst, 38%necrosis, 15% abscess) and gallbladder drainage in high-surgical risks with acutecholechystitis (nz42). Less common indications were: NPFC (nz6, 66% liver abscess, 33%biloma), bile duct and small bowel anastomosis (nz5, 60% transluminal, 40% percutaneous-assistedtrasnprosthetic therapy for biliary access). Technical success was achieved in 91.9% of thepatients, and clinical success in 83.96% of the patients (Table). Larger LAMS were used (10or 15 mm diameter, 10 mm of length) in every indication, except biliary drainage where 8mm LAMS were used. 79% had cold LAMS. In 13 patients (9.6%), technical difficultiesarose in LAMS delivery (12 cold AXIOS), but technical success was finally achieved in 10 ofthese patients, in one of them, a second LAMS was used. In 8 patients, there weredifficulties to deliver the LAMS, and in 5 patients partial migration happened after rightdelivery. In 39 patients (28.7%), coaxial stent was used (excluded nasocystic drainage), 7 ofthem (18%) in procedures with technical difficulties. 11.4% of complications, 5 severe and2 fatal complications. 11 LAMS (11.6%) migrated in the follow-up, 9 were asymptomaticand discovered in next procedure. LAMS removal succeeded in 50/53 attempted cases,and TTSE was successfully performed without any instance of LAMS dislodgement in 51cases. Conclusion: LAMS are expanding the borders of therapeutic EUS-guided endoscopy, they providerobust anchorage between non-adherent structures. Technical and clinical success arehigh in difficult patients and procedures. Although difficult deliver of LAMS occur in somepatients, in most of them do not jeopardize technical success. Pancreatic fluid collections Non pancreatic fluid collections Gallbladder Biliary drainage Small bowel Technical success Technical success/ 67/73 5/6 39/42 10/10 4/5 total procedures Frequency 91.78% 83.33% 92.86% 100% 80% Technical difficulty Procedures 9/73 0/6 4/42 0/10 0/5 technically difficult/total procedures Frequency 12.33% 0% 9.52% 0% 0% Clinical success Clinical success/ 51/55 5/6 25/33 4/7 4/5 total procedures (with available data) Frequency 92.73% 83.33% 75.76% 57.14% 80% Complications Number of 3/73 3/6 6/39 1/9 2/5 complications/ total patients Frequency 4.1% 50% 15.38% 11.11% 40% Removal success Succesfully 35/36 4/4 7/9 2/2 2/2 removal/ intention to remove Frequency 97.22% 100% 77.78% 100% 100% Trans-stent (TS) procedures TS done/total 32/73 2/6 11/42 2/10 4/5 procedures Frequency 43.8% 33.3% 26.2% 20% 80% Number of TS procedures Number (Standard deviation) 2.12 (1.82) 1 (0) 1.09 (0.30) 1 (0.71) 2 (1.73) AB426 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
32 Mo1457 An Alternative Method of Drainage of Pseudocysts in Presence of Big Varices in the Fundus. Pankaj N. Desai* 1 Gastro Intestinal Endoscopy Centre, Gastro Care, Surat, India; 2 Endoscopy, Surat Institute Of Digestive Sciences, Surat, India Aims: A study 18 cases of draining pseudocysts complicated by portal hypertension and gastric varices with EUS guided locating the site of puncture distally on the bulge. Methods: 18 cases from all that were referred to us from 1 st January 2011 to May 30, 2014 with pseudocysts were found to be complicated with fundic and esophageal varcies secondary to splenic vein. UES revealed big varices around the GE junction and the proximal body and no window was found for EUS guided cyst drainage in the conventional manner. The bulge of the cyst was followed distally with an EUS scope and an area devoid of varices was found distally. Here thetipoftheeusscopewasfullyupanditwasimpossibletogeta19gneedleout for puncture and further steps of conventional cyst drainage. Ttherefore we marked the area with biopsy forcpes taking a pinch of tissue for identification on passage of the side viewing scope subsequently. A conventional ERCP 4.2mm channel scope from Olympus was then passed, positioned in front of the marked area and the cyst punctured around the mark with a needle knife papillotome from Boston and guide wire placed under fluoroscopic control. The tract was then dilated with a 6.5Fr cystotome from Endoflex and dilated with a CRE balloon upto 12mm only to avoid bleeding. Two 10 Fr Double pig tail stents were kept. In cases with necrosis and additional naso cystic catheter was placed for lavage which was removed after 48 to 72 hours exchanging it for an additional 10Fr DPT stent. ERCP done if a leak was suspected at the time of removal of naso cystic drain and stent placed. Stents were removed after six weeks to three months and the PD stent removed or changed as needed. Results: Bulge Present - 18 ( 100% )Puncture Possible around marked site - 17 ( 94.4% )Bleeding ( Minor ) - 3 ( 16.7% )Necrosis Present - 5 (27.7% )Infected Fluid - 4 ( 22.2% )Naso Cystic Drain kept - 9 ( 50% ) Perforation 0 ( 0% )Sepsis - 4 ( 22.2% )ERCP Performed - 6 ( 33.3% )Cysto gastrostomy stents Removed - 12 ( 63.1% )Stents still present - 4 ( 22.2% )Lost to Follow up - 2 (11.1%)Procedure Related Mortality - 0 ( 0% )The bleeding was minor from the wall and was treated with injection of adrenaline and balloon tamponade.the sepsis was treated with antibiotics for 5 to 7 days and was seen in patients with necrosis and infected fluid.4 patients had a disrupted duct and hence the stents have not been removed. Conclusions: In difficult situations of pseudocysts complicated with varices, puncturing distally on the bulge at a site marked by EUS scope is a feasible alternative. EUS guide drainage is difficult in these situations as the scope is angled acutely and this makes the procedure very difficult.the complications rates are also reasonable. are undergoing ETN, 4 pts are undergoing ETN with LAMS in situ. 1 patient died from multiorgan failure. Conclusions: Endoscopic drainage of WON using EUSguided LAMS stents is a safe and effective for initial drainage; however, despite the large lumen, stent occlusion by solid necrosis occurs early and frequently, so that scheduled ETN is advisable. LAMS offer a convenient conduit for ETN. Table 1 Stent N Time to reintervention, mean (range) Indications for re-intervention Cystgastrostomy (4-33) Fever 2/7 Repeat Necrosectomy 4/7 Stent removal after resolution of WON on imaging 1/7 Cystgastrostomy with solus stent Dual cystgastrostomy with solus stents Cystgastrostomy and Cystdoudenostomy with solus stents Total (range 3-33) 5 11 (3-22) Fever 3/5 Pain 1/5 Repeat Necrosectomy 1/ (7-12) Fever 1/3 Repeat necrosectomy 2/ (9-25) Fever 3/4 Repeat necrosectomy 1/4 Fevers (9patients) Repeat necrosectomy (8) Persistent symptoms (1) Stent removal for WON resolution of WON on imaging (1) Occluded LAMS at repeat endoscopy (%) 42.8% 40% 67% 50% 47% Mo1458 Fully Covered Lumen Apposing Metal Stent for the Management of Walled Off Necrosis (Won): a Single Center Experience Saleh Elwir*, Stuart K. Amateau, Shawn Mallery, Tom Fang, Martin L. Freeman, Mustafa A. Arain Gastroenterology, University of Minnesota, Minneapolis, MN Aim: To report preliminary results associated with the use of a short, dumbbell shaped fully covered lumen apposing metal stent (LAMS) in the management of necrotizing pancreatitis (NP) complicated by walled off necrosis (WON). Methods: Data were extracted from a prospectively maintained database of patients (pts) with WON. Pts were managed by a multidisciplinary team with a step up approach utilizing endoscopic +\- percutaneous drainage (PCD)as first line treatment, with surgery reserved for failures. Pts treated with a 15mm inner diameter, 1cm length dumbbell shaped EUS guided LAMS were analyzed. Results: 22 pts (82.6% males, mean age 49 yrs) with WON underwent drainage/ endoscopic transluminal necrosectomy (ETN) utilizing LAMS from Apr Nov WON was pancreatic (nz5) peripancreatic (nz2) and both (nz15). WON collection size ranged from 5.9 cm x 3.4 cm to 30.5 cm x 30.8 cm. Indications for drainage were: infected WON (nz9), persistent pain/failure to thrive (nz12) and gastric outlet obstruction (nz1). Median time from presentation of NP to intervention was 44 days (range ). Drainage was achieved via EUS guided cystenterostomy in all: single cystgastrostomy (CG) in 15 pts, dual site CG in 3 pts, and CG plus cystduodenostomy (CD) in 4. 6 pts required PCD in addition to LAMS placement, 2 pts eventually underwent surgery. LAMS placement was successful in 28/29 attempts with one failure in a 5.9 by 3.9 cm peri-pancreatic cavity with dense fat necrosis resulting in the stent not expanding; treated with double pigtail stents instead. There were no immediate complications. Fever developed within 6 days of LAMS placement in 2/5 initial pts treated with LAMS; both pts had LAMS occlusion due to impacted necrotic tissue. When feasible, all subsequent pts were treated with one (12 pts) or more (1 pt) 10 F double pigtail plastic stents (PS) through the lumen of the LAMS to maintain patency, however fever occurred within first two weeks in 6/13 and stent occlusion in 7/13. To date, ETN has been done in 19/21 pts (Table 1). ETN was done after LAMS removal in 7 pts and through the LAMS lumen in 9 pts. LAMSs were removed in 16 pts after a mean of 2.5 procedures (range 2-5) and remained in situ for a mean of 25 days (range 3-88 days). In 1 pt LAMS stent migrated into the lesser sac and was retrieved endoscopically without incident. At last follow up 8 pts had resolution of WON with no stents in situ, 8 pts have had LAMS removed with only PS in situ and Mo1459 EUS-Guided Drainage of Pancreatic Fluid Collections Using a Novel Lumen-Apposing Metal Stent on an Electrocautery Enhanced Delivery System: a Large Retrospective Multicenter Study Alberto Larghi* 1, Rastislav Kunda 2, Markus Dollhopf 3, Andres Sanchez-Yague 4, Uwe Will 5, Ilaria Tarantino 6, Joan B. Gornals 7, Sebastian Ullrich 8, Alexander Meining 9, Jose Miguel Esteban Lopez-Jamar 10, Thomas Enz 11, Geoffroy Vanbiervliet 12, Frank P. Vleggaar 13 1 Digestive Endoscopy Unit, Catholic University, Rome, Italy; 2 Department of Surgical Gastroenterology L, Aarhus University Hospital, Aarhus, Denmark; 3 Department of Gastroenterology, Klinikum Neuperlach, München, Germany; 4 Endoscopy Unit, Hospital Costa del Sol, Marbella, Spain; 5 Department of Gastroenterology, Municipal Hospital Gera, Gera, Germany; 6 Endoscopy Unit, Department of Diagnostic and Therapeutic Services, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Palermo, Italy; 7 Endoscopy Unit, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, Spain; 8 Department of Internal Medicine I, Asklepios Klinik Altona, Hamburg, Germany; 9 Department of Medicine II Klinikum rects der Isar, Technical University of Munich, Munich, Germany; 10 Endoscopy Unit, Hospital Clinico San Carlos, Madrid, Spain; 11 Department of Gastroenterology, Kliniken Nagold, Nagold, Germany; 12 Digestive Endoscopy Unit, Hôpital L Archet 2, University Hospital of Nice, Nice, France; 13 Department Gastroenterology and Hepatology, University Medical Center Utrecht, Utrech, Netherlands Background and Aims: A newly lumen-apposing, self-expanding fully covered metal stent incorporated in an electrocautery enhanced delivery system, the Hot-AXIOS system (Xlumena Inc., Mountain View, California, USA), has recently become available to perform endoscopic ultrasound (EUS)-guided drainage procedures. The aim of this study was to analyze the safety and clinical effectiveness of this new device for EUS-guided drainage ann treatment of pancreatic fluid collections (PFCs). Methods: Retrospective analysis of all consecutive patients with PFCs who underwent EUSguided drainage using the Hot-AXIOS in 13 European Centers. Results: 93 patients Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB427
33 (median age of 60 yrs; M/F:71/22) with PFCs (median diameter 10 cm; range 3,8-24,6 cm) underwent drainage using the study device. Four patients (4.3%) had an acute peripancreatic fluid collection (APFC), 18 (19.4%) a pseudocyst (PC), 19 (20.4%) a pancreatic abscess, and 52 (55.9%) walled-off necrosis (WON). In 83 cases (89.2%) the drainage was performed from the stomach, while in 10 cases (10.8%) through the duodenum. In 24 patients (25.8%), access to the PFC was obtain using a 19- gauge needle, followed by placement of a inch guide-wire through which the Hot-AXIOS device was advanced to cautery dilate the tract, penetrate into the cavity and then release the stent. In the remaining 69 patients (74.2%), access to the PFC was obtained directly with the study device without fluoroscopic assistance, which was followed by immediate stent placement. A 15 mm internal diameter and 10 mm long stent was used in 53 patients, a 10mm x 10mm in 37 patients, and a 6mm x 8mm stent in two patients with small abscesses. In the remaining patient, two stents (one 15mmx10mm and one 10mmx10mm) were placed transgastrically. After stent placement, additional PFCs other than the known abscesses were found to harbor an infection, accounting for an overall of 53 (57%) infected lesions treated. Direct necrosectomy (DEN) was carried out in 31/52 (59.6%) cases of WON and in 2/4 cases (50%) of APFC. Complete resolution of the PFC was obtained in 86 cases (92.5%), with no recurrence during follow up. Treatment failure occurred in 6 patients due to persistent infection requiring surgery (3); perforation and massive bleeding caused by the naso-cystic drainage catheter (2); need for a larger opening to extract large necrotic tissue pieces (1). Major complications occurred in 5 patients (perforation and massive bleeding caused by the naso-cystic drainage catheter; one pneumoperitoneum and one stent dislodgement during DEN; one post-drainage infection) and were mostly not related to the drainage procedure. Conclusions: EUS-guided drainage with the Hot-AXIOS system is a safe, easy to perform, and highly effective minimally invasive treatment modality for PFCs. Mo1460 Endoscopic Ultrasound (EUS): an Additional Tool for the Diagnosis and Treatment of Retroperitoneal Cysts Joshua Spaete* 2, Anthony W. Castleberry 1, Sandra S. Stinnett 1, Dan G. Blazer 1, Rebecca A. Burbridge 2 1 Surgery, Duke University Medical Center, Durham, NC; 2 Medicine, Duke University Medical Center, Durham, NC Background: Retroperitoneal cysts are rare abdominal tumors. While most are benign, some do harbor malignant potential. Imaging can help further classify cysts, however definitive non-invasive diagnosis remains a challenge. EUS-FNA has been shown to be a safe and effective technique to aid in the diagnosis of pancreatic lesions, but its use in retroperitoneal cysts is limited to a single case report. Aim: To determine whether EUS-FNA is a safe and effective method to establish a diagnosis in patients with retroperitoneal cysts. Methods: A retrospective analysis of a tertiary medical center from identified patients who underwent pathologic sampling of a retroperitoneal cyst.patients who were less than 18years of age and/or patients who had intra-abdominal masses arising from the pancreas, liver, spleen, gastrointestinal tract and kidney were excluded. Age, gender, presenting symptoms and signs, duration of symptoms, size of cyst, diagnostic modality, cyst fluid characteristics, type of lesion, operative indication, treatment, surgical intervention, surgical complication, as well as final outcome were recorded Results: A total 31 patients were identified who met eligibility criteria. Of these, 20 were female and 11 were male. The median age was 54 with a range from 22 to 79. Most cysts were discovered incidentally (61%). Cyst size ranged from 3cm to 18cm. Diagnosis was achieved most frequently at the time of surgery in 19 of the 31 patients. Of the 16 patients who underwent a diagnostic modality prior to surgery, 9 were EUS-FNA, 6 were CT guided biopsy, and 1 was a transabdominal US guided biopsy. A diagnosis was achieved in 6 of the 9 (67%) patients who underwent EUS-FNA. Two out of three of these patients underwent surgical intervention at our center. Endoscopic features, cytology and fluid analysis were consistent with a benign process and on final surgical pathology neither was malignant. No complications were reported with nonsurgical diagnostic interventions. Complications occurred during or following surgery in 5 cases. Conclusions: This is the largest study to examine EUS-FNA of retroperitoneal cystic lesions. Diagnosis was achieved in approximately 70% of patients who underwent EUS our series. In addition, no complications were reported with EUS-FNA. While the number of patients is limited, we conclude that EUS-FNA is a safe and effective modality to diagnose retroperitoneal cysts in amenable lesions. Mo1461 Endoscopic Ultrasound (EUS)-Guided Needle Based Confocal LASER Endomicroscopy (ncle) for Diagnosis of Cystic Pancreatic Lesions (CPLs): Implications for Management Somashekar G. Krishna*, Benjamin Swanson, Peter Muscarella, Mark Bloomston, Victorio P. Pidlaoan, Samer El-Dika, Jon P. Walker, Razvan Arsenescu, Phil Hart, Darwin Conwell Department of Gastroenterology, Hepatology, and Nutrition, The Ohio State University Medical Center, Columbus, OH Background and Aim: Accurate diagnosis of CPLs is of paramount importance given its impact on patient management. The current strategy relies on a complex multidisciplinary approach with imaging exams and EUS evaluation. EUSnCLE is a novel imaging technology that enables in vivo and real-time imaging of the inner wall of CPLs at the microscopic level. We sought to identify and validate new diagnostic patterns on ncle for diagnosis of CPLs. Methods: This is a retrospective analysis of patients who underwent EUS-guided ncle for evaluation of indeterminate CPLs from 5/ /2014 at a single tertiary-care center. For each case, visualized ncle criteria (table 1) and ncle based presumptive diagnosis were documented and compared to the final diagnosis. Final diagnosis was defined using either the surgical diagnosis or a multidisciplinary consensus (table 1). Patients were followed as per current guidelines for CPLs. Results: A total of 32 patients underwent EUS-nCLE of which 1 patient (3.1%) had acute pancreatitis following the procedure. A surgical/consensus diagnosis of CPL was not available in 6 patients leaving 26 patients (15 female, mean age years) for final analysis. The mean size of the CPLs was mm. In all, there were 8 branch duct Intraductal Papillary Mucinous Neoplasms (BD-IPMNs), 9 serous cystadenomas (SCA)s, 4 pseudocysts, 2 lymphoepithelial cysts, 1 adenocarcinoma, 1 carcinoma with sarcomatoid differentiation, and 1 retention cyst. Among these 7 (27%) underwent surgical resection, and pathologic confirmation was available.utilizing ncle criteria, the sensitivity, specificity,ppv,npv,andaccuracyfordiagnosisof BD-IPMN were 89%, 100%, 100%, 94%, and 96% respectively. The sensitivity, specificity, PPV, NPV, and accuracy for SCA were 90%, 100%, 100%, 94%, and 96% respectively. For diagnosis of pseudocysts, the sensitivity, specificity, PPV, NPV, and accuracy were 75%, 100%, 100%, 96%, and 96% respectively.receiver operative characteristic analysis revealed that EUS-nCLE findings of finger-like projections (AUCZ0.97) and superficial vascular network (AUCZ0.91) were most predictive for diagnosis of BD-IPMN and SCA, respectively (table 2). Conclusion: EUS-nCLE is a promising means of providing a definitive diagnosis of CPL subtype by identifying patients at risk of pancreatic cancer and avoiding surgeries for cysts with a benign outcome. Multicenter studies with pathological correlation are necessary to validate these findings. Table 1 Needle based confocal laser endomicroscopy criteria for diagnosis of cystic pancreatic lesions. Diagnosis of branch duct Intraductal Papillary Mucinous Neoplasms Finger-like projections Layering of overlapping epithelium Parallel thick dark bands alternating with thinner white bands (blood vessels) Presence of blood vessels Diagnosis of Serous cystadenoma Superficial vascular network Multiple blood vessels Dense background of small 7-8 micron sized epithelial/cuboidal cells Diagnosis of pseudocyst Clusters of bright, floating, hetergeneous particles Absence or paucity of blood vessels Diagnostic rationale for cystic pancreatic lesions Surgical histopathology 7 For patients without surgical resection IPMN CEA O 190 ng/ml, cyst communication with main pancreatic duct 3 Multiplicity of cysts, cyst communication with main pancreatic 3 duct Adenocarcinoma Conclusive cytology 1 Serous cystadenoma CEA! 1 ng/ml, follow-up O 1 year, MRI/EUS findings of SCA 4 MRI/EUS characteristic of SCA, acellular cytology, no fluid aspirated 4 Pseudocyst History of pancreatitis, EUS-FNA cytology with macrophages and 4 debris Total 26 AB428 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
34 Table 2. Receiver operative characteristics of endoscopic ultrasound guided needle based confocal laser endomicroscopy prediction of cystic pancreatic lesion. Area under the curve P value Diagnosis of branch duct Intraductal Papillary Mucinous Neoplasm Finger-like projections 0.97!0.001 Layering of overlapping epithelium 0.94!0.001 Parallel thick dark bands alternating with thinner white bands (blood vessels) Absence of superficial vascular network Presence of blood vessels (fewer) Diagnosis of serous cystadenoma Superficial vascular network Multiple blood vessels Absence of finger like projections Dense background of small 7-8 micron sized epithelial/cuboidal cells Mo1462 A Prospective Study to Assess the Safety and Yield of Endoscopic Ultrasound With Fine Needle Aspiration in a Tertiary Referral Centre. Marie Ooi*, Ken Liu, Santosh Sanagapalli, Crispin Corte, Avelyn Kwok, Peter Katelaris, Rupert W. Leong Gastroenterology, Concord Hospital, Sydney, NSW, Australia Background: Recently endoscopic ultrasound-guided fine needle aspiration (EUS- FNA)hasbeenusedasanalternativetosurgical or radiological methods for tissue acquisition. EUS-FNA allows both morphologic and cytologic analysis of lesions within and surrounding the digestive tract. The aim of this study was to assess the overall safety and complication rates from EUS-FNA. Methods: All patients who underwent EUS in our centre in a 10-month period in 2014 were studied prospectively. Data collected included indication for EUS, demographics, needle gauge and immediate and delayed complications, the latter assessed via a telephone call at 30 days. Results: Of 298 consecutive patients who underwent EUS, 85 (28.5%) underwent fine needle aspiration. The major indication for EUS- FNA was for investigation of pancreatic lesions in 78 patients (90.7%), of which nz29 were solid and nz49 were cystic. The other indication was for submucosal gastric lesions in 7 patients (8.2%). Fifty of the lesions were sampled using a 25G needle, 32 with a 22G and 3 with a 19G needle. A mean of 4.2 needle passes were made. All patients with cystic lesions received intravenous antibiotics during the procedure. Complications were observed in 3 (3.5%) patients. Two patients developed abdominal pain and 1 developed fever and rigors which resolved with oral antibiotics. These complications all occurred after FNA of pancreatic cystic lesions. No patients developed acute pancreatitis, bleeding or aspiration pneumonia. There were no procedure-related deaths. Out of 85 FNA performed, 82 (96.5%) provided a definitive diagnosis. Three patients (3.4%) had inadequate tissue which required repeat EUS-FNA or other modalities (radiology and/or surgical-guided FNA) to obtain diagnosis. Conclusion: These data confirm that EUS- FNA is a safe method for tissue acquisition with a low rate of complications and high diagnostic yield. Mo1463 Endoscopic Ultrasound Guided Fine Needle Aspiration Cytology (EUS FNA) - Evaluation of the Diagnostic Yield Pre and Post Rapid Onsite Evaluation (ROSE) Chintan Patel, Rahul Shah, Jhulana K. Jena, Vipulroy Rathod* Department of Gastroenterology and Hepatology, Endoscopy Asia, Mumbai, India Introduction: Over the past 2 decades, EUS FNA has become the preferred procedure to obtain tissue for the diagnosis of gastrointestinal (GI) tract and peri luminal organ lesions with acceptable accuracy and safetyit is believed that ROSE reduces the number of inadequate FNA samples and improves the sensitivity and overall accuracy of EUS-FNA for the diagnosis of various GI tract tumors, as shown in studies on pancreatic solid tumorsalthough experts recommend an on-site evaluation of samples obtained in order to optimize the diagnostic yield of EUSguided FNA, its effect on diagnostic accuracy has not been properly definedaim:our objective was to evaluate the yield of EUS FNA after acquisition of ROSE with an experienced cyto-technician. Methods: We retrospectively collected data of all EUS FNA s performed at a tertiary center 1 year prior to and post acquisition of a ROSE by a cyto-technician who evaluated for tissue adequacy and excluded artifacts.we used 22 or 25 gauge Wilson Cook TM needles depending on the site of the lesion and mode of puncture i.e. transduodenal or transgastric.cystic lesions were excluded from this study. Results: Results from the EUS FNA were divided into three categories: EUS FNA where a definitive diagnosis was achieved, inadequate for diagnosis or non cellular material and negative.hepatobiliary cases included pancreatic, gall bladder, liver and abdominal lymph nodes lesions whereas pulmonary cases included mediastinal, para tracheal, sub and supra carinal lymph nodes.of the 53 pre ROSE patients who had negative or inconclusive results all except 7 patients had a definitive diagnosis on the second attempt. These patients were then referred for an alternative technique of biopsy and were subsequently lost to follow up.in the post ROSE patients all 13 patients had a diagnosis in the second attempt. Conclusions: In our study, diagnostic yield of EUS FNA after acquisition of ROSE increased by 11.1 % (pre ROSE- 78.8%, post ROSE- 89.9%). Perhaps this also reflects our evolving experience and technological advances.little is known about the impact of ROSE on EUS-guided FNA procedural time, and it remains unclear whether using ROSE prolongs the procedure or makes it less timeconsuming by reducing the number of needle passes.however, in one study using a new EUS histology needle, the authors reported a correct diagnosis of 86% and an overall diagnostic accuracy for the detection of malignancy of 92.9% without a pathologist present for the endoscopy. FNA Results: Results Pre ROSE Post ROSE Positive Negative 36 8 Inconclusive or inadequate 17 5 FNA Sites FNA Site Pre ROSE Post ROSE Pulmonary Hepatobiliary Sub Mucosal 11 6 Miscellaneous 7 5 Mo1464 Can a Core Biopsy Needle Acquire More Efficient Specimen Comparing a Conventional Needle in EUS-Guided Tissue Sampling? Hal Sol Lee, Chang-Min Cho*, Han-Ik Bae, Jung Sik Jang Pathology, Kyungpook National University Medical Center, Daegu, Korea (the Republic of) Background and Aims: An endoscopic ultrasound-guided tissue sampling using a new core needle was developed to improve diagnostic accuracy by obtaining histologic core samples. Many previous studies have revealed the advantages of endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) using a new core biopsy needle; less needle passes, more tissue acquisition and higher diagnostic yield. However, no data was compared the analysis of histologic specimen itself betweentwotechniques.thisstudyaimedtocomparetheefficient portion in histologic core samples of EUS-FNB with those of standard endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) in patients with solid mass lesions. Patients and Methods: Patients with solid mass lesion who were referred for EUS-guided tissue acquisition were prospectively enrolled. After randomization, EUS-guided tissue acquisition using core biopsy needle or conventional needle was performed. Up to three passes was performed until core biopsy sample was obtained. The opposite needle was used after the failure of core tissue using initial needle. All obtained samples were placed into tissue tray with formalin for histologic analysis without on-site evaluation. Using computerized anylsis for a scanned histologic slide, the efficient portion among overall scanned slide area was compared between two techniques (figure 1). Results: From April 2013 to May 2014, a total of 58 patients were enrolled and randomized; 29 in the FNB group and 29 in the FNA group were analyzed. No significant differences were identified between two groups with respect to age, gender, or location and size of the tumor.lessneedlepassesrequiredtoobtaincoresamplewasaccomplishedinfnb group (p! 0.05). No technical failures occurred in both groups. There was no difference in diagnostic accuracy between FNB group (79.3%) and FNA group (86.2%) (p Z 0.487) and the efficient portion in histologic sample between FNB group ( ) and FNA group ( ) (p Z 0.280). Conclusions: The efficient histologic portion of FNB and FNA in patients with solid mass lesions was comparable: however, fewer passes of needle puncture were required in EUS- FNB. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB429
35 Table 1. Comparison of baseline characteristics, diagnostic performances, and patholoic slides between two techniques EUS-FNA (n[29) EUS-FNB (n[29) p value Age (year), median (range) 66 (26-85) 63 (36-81) Gender (male: female) 18:11 22: Site, n (%) Stomach 3 (10.3) 6 (20.7) Lymph node 8 (27.6) 6 (20.7) Retroperitoneum 2 (6.9) 2 (6.9) Pancreas 8 (27.6) 8 (27.6) Liver 4 (13.8) 3 (10.3) Others 4 (13.8) 4 (13.8) Size (mm), mean (SD) 39.1 (27.5) 33.7 (18.5) Needle passes, mean (SD) 2.5 (0.8) 1.6 (0.7) Diagnostic accuracy (%) 79.3% 86.2% Overall area, mean (SD) 1,636,600 1,320, (1,813,760) (1,101,620) Area for representative cells, 86,412 (113,724) 100,142 (223,754) mean (SD) Efficient portion (%), mean 8.0 (10.7) 12.1 (20.2) (SD) EUS-FNA, endoscopic ultrasound-guided fine needle aspiration; EUS-FNB, endoscopic ultrasound-guided fine needle biopsy; SD, standard deviation Figure 1. Compterized analysis of histologic slide. Total area of a histologic slide for aspiration sample (left) was compared with area of core tissue arae (right). Mo1465 The Diagnostic Performance of Cell Block in Combination With Cytology by Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA) in Intra-Abdominal Mass Lesions Nonthalee Pausawasdi*, Penprapai Lertrattananon, Wipapat V. Chalermwai, Phunchai Charatcharoenwitthaya Medicine Department, Gastroenterology Division, Faculty of Medicine, Siriraj Hospital, Bangkoknoi, Thailand Background: EUS-FNA is widely used for tissue acquisition of intra-abdominal mass. Cytological analysis from the FNA specimens, however, can be challenging especially when differentiating types of malignancy is needed due to limited tissue quantity. Cell block preparation offers histology and immunohistochemistry examination which potentially beneficial. Nonetheless, the data on its usefulness is scarce. Aims: To assess the diagnostic accuracy of combined cytology and cell block obtained from EUS-FNA of intra-abdominal mass and to assess the prognostic factors of tissue adequacy for both techniques. Methods: Patients with intraabdominal mass undergoing EUS-FNA from were identified using EUS database. Those with both cytology and cell block specimens were recruited and the slides were reviewed by a cytopathologist blinded to clinical data. Results: 166 patients (mean age 5814 years, 54% male) were recruited. Based on the pathology results and clinical course, 75% of patients had malignancy (pancreatic cancer 35%, metastatic malignancy 28%, lymphoma 4%, GIST 4%, sarcoma 1%, cholangiocarcinoma 2%, neuroendocrine tumor 0.5%, and hepatoma 0.5%) and 25% had inflammatory/reactive changes. Most common sites of mass lesions were pancreas (53%) and lymph nodes (38%). The mean size of lesions was cm. EUS-FNA was performed using a 22-gauge needle with 5 ml of suction and the mean number of passes was The percentage of cases in which adequate specimen obtained for cytology and cell block was 79% and 78% respectively. Logistic analysis showed that size of the lesion was predictive of tissue adequacy for both cytology and cell block. Cytology had sensitivity 68.5% (95% CI, ), specificity 95.7% (95% CI, ), positive predictive value (PPV) 98.7% (95% CI, ), and negative predictive value (NPV) 39.3% (95% CI, ) with AUROC (95% CI, ). Cell block had sensitivity 65.4% (95% CI, ), specificity 96% (95% CI, ), PPV 98.5% (95% CI, ), NPV 40.7% (95% CI, ) with AUROC (95% CI, ). The results also showed that 19% of patients with inadequate samples for cytology had acceptable tissue adequacy for cell block analysis and diagnosis can be made. Moreover, cell block analysis detected 8 malignant lesions that were not diagnosed by cytology. The diagnostic performance of the combined cytology and cell block analysis was superior to either cytology or cell block alone (p!0.05) as demonstrated by an improvement of sensitivity to 74.6% (95% CI, ) while maintaining high specificity of 96% with AUROC (95% CI, ). Conclusions: This study ascertains that the combination of cytology and cell block analysis increases the diagnostic accuracy of EUS-FNA. This approach shows a promise in practice where on-site pathology is not available. Mo1466 How Good Are EUS 19 G Core Biopsies in Diagnosing the Correct Etiology of a Solid Mass?: a Meta-Analysis and Systematic Review Anand Oroskar, Srinivas R. Puli* Department of Gastroenterology and Hepatology, University of Illinois- Peoria, Peoria, IL Background: The published data on accuracy of EUS 19 G core biopsy in diagnosing the correct etiology for solid mass has not been well documented. Diagnosing the correct etiology for a mass is critical from a therapeutic stand point. Aim: To evaluate the accuracy of EUS 19 G core biopsies in diagnosing the correct etiology for a solid mass. Method: Study Selection Criteria: Only EUS 19 G core biopsy studies confirmed by surgery or appropriate follow-up were selected. Only studies from which a 2 X 2 table could be constructed for true positive, false negative, false positive and true negative values were included.data collection & extraction: Articles were searched in Medline, Pubmed, Ovid journals, Cumulative index for nursing & allied health literature, International pharmaceutical abstracts, old Medline, Medline nonindexed citations, and Cochrane Central Register of Controlled Trials & Database of Systematic Reviews. Two reviewers independently searched and extracted data. The differences were resolved by mutual agreement. 2 X 2 tables were constructed with the data extracted from each study.statistical Method: Meta-analysis for the accuracy of EUS was analyzed by calculating pooled estimates of sensitivity, specificity, likelihood ratios, and diagnostic odds ratio. Pooling was conducted by both Mantel-Haenszel method (fixed effects model) and by the DerSimonian Laird method (random effects model). The heterogeneity of studies was tested using Cochran s Q test based upon inverse variance weights. Results: Initial search identified 3610 reference articles, of these 360 relevant articles were selected and reviewed. Data was extracted from 6 studies (NZ 336) which met the inclusion criteria. Pooled sensitivity of EUS 19 G Core biopsies in diagnosing the correct etiology for solid mass was 91.6 % (95 % CI: ). EUS 19 G core biopsies had a pooled specificity of 95.9% (95% CI: ). The positive likelihood ratio of EUS 19 G core biopsies was 9.08 (95 % CI: ) and negative likelihood ratio was 0.12 (95% CI: ). The diagnostic odds ratio, the odds of having correct histologic etiology of a mass in positive as compared to negative EUS-FNA studies was (95% CI: ). All the pooled estimates calculated by fixed and random effect models were similar. SROC curves showed an area under the curve of The p for chi-squared heterogeneity for all the pooled accuracy estimates was O Conclusion: EUS 19 G core biopsies have an excellent diagnostic value in detecting the correct etiology for a solid mass. EUS 19 G core biopsies should be strongly considered for evaluation of solid lesions. Mo1467 A Global Survey Evaluating the Global Practice Patterns of EUS- Guided Tissue Sampling; Preferences for Tissue Acquisition and Processing Priscilla A. Van Riet*, Djuna L. Cahen, Jan-Werner Poley, Marco J. Bruno Department of Gastroenterology and Hepatology, Erasmus University Medical Center Rotterdam, Rotterdam, Netherlands Background: Although endoscopic ultrasound (EUS) guided tissue sampling is performed widely, global practice guidelines are lacking and usage is based on local expertise and consensus. This survey was performed to gain insight in the current tissue sampling routines and evaluate diversities among various continents. Methods: Four hundred endosonographers from the United States (US), Europe, and Asia were approached to complete an online survey, consisting of 60 multiple-choice questions regarding details on sampling techniques and specimen processing. Questions concerned both fine needle aspiration (FNA) and fine needle biopsy (FNB). Results: Hundred eighty-six surveys were returned (47%); 85 (46%) from Europe, 54 (29%) from the US, and 47 (25%) from Asia. The median age of the respondents was 46 (IQR 41-52) years. Most were male (90%), gastroenterologists (96%), working in an academic setting (79%), and performing O100 EUS-FNA procedures per year (68%).Overall, the 22G needle was preferred most (table 1). However, for FNB of submucosal masses, a 19G needle was preferred (63%). The reported number of needle passes varied according to target lesion; single for cystic AB430 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
36 lesions (80%) and two to three for solid lesions (53%). Most respondents preferred fanning as a needle motion technique for FNA (64%), while for FNB, fanning and only to and fro were equally favored (44% and 46%, respectively).to increase the yield, 134 respondents (73%) routinely looked for tissue cores after FNA, and 136 (73%) prepared a cytological sample after FNB. FNA specimens were preserved in Cytolit by 72 (52%) of the American and European respondents, whereas in Asia, a tied standing was reported for the use of saline (27%) and alcohol (38%) (p!0.001). Rapid on-site pathological evaluation (ROSE) was used by almost all American participants (98%), while only half of the other respondents had ROSE at their disposal (51%, p!0.001). Limited pathology staffing was given as the primary reason to omit ROSE (nz49, 74%). Conclusion: For EUS guided tissue sampling, the majority of respondents prefer a 22G needle, for all but submucosal lesions, and carry out 2-3 needle passes, except for cystic lesions, where a single pass is generally performed. Specimens are mostly preserved in Cytolit in Europe and the US, while alcohol and saline are preferred in Asia. Rapid on-site tissue evaluation is standard procedure in the US, but not in Europe and Asia, because of shortage in manpower. The consequences of these differences on outcome have yet to be evaluated in prospective studies. Table 1. Practice patterns regarding needle size and number of needle passes Variables Europe n [ 38 (%) US n [ 25 (%) Asia n [25 (%) Total N [ 88 (%) p- value* Needle size for FNA Submucosal mass 19G 21 (55) 7 (28) 11 (44) 39 (44) G 12 (34) 16 (64) 14 (56) 43 (49) 25G 4 (11) 2 (8) 0 (0) 6 (7) Overall 19G 41 (27) 14 (14) 19 (19) 74 (21) 22G 75 (50) 58 (58) 58 (58) 192 (55) 25G 35 (23) 28 (28) 23 (23) 86 (24) Europe n Z 37 (%) US n Z 16 (%) Asia n Z19 (%) Total N Z 72 (%) p-value* Needle size for FNB Submucosal mass 19G 26 (70) 10 (63) 9 (47) 45 (63) G 10 (27) 6 (38) 9 (47) 25 (35) 25G 1 (2.7) 0 (0) 1 (5.3) 2 (2.8) Overall 19G 62 (42) 19 (30) 23 (30) 104 (36) 22G 67 (45) 39 (61) 44 (58) 150 (52) 25G 19 (13) 6 (9.0) 9 (12) 34 (12) Europe n Z 59 (%) US n Z 34 (%) Asia n Z22 (%) Total N Z 115 (%) p-value* Nr. of passes for FNA Pancreatic cystic lesion 1 49 (83) 27 (79) 17 (77) 93 (81) O1 10 (17) 7 (21) 5 (23) 22 (19) Overall 1 59 (25) 29 (21) 22 (25) 110 (24) (50) 61 (45) 46 (51) 225 (49) O3 58 (25) 46 (34) 21 (24) 125 (27) Europe n Z 50 (%) US n Z 30 (%) Asia n Z22 (%) Total N Z 102 (%) p-value* Nr. of passes for FNB Pancreatic cystic lesion 1 38 (76) 25 (83) 14 (64) 77 (76) (20) 4 (13) 7 (32) 21 (21) O3 2 (4.0) 1 (3) 1 (5.0) 4 (4.0) Overall 1 51 (26) 32 (27) 18 (20) 101 (25) (57) 63 (52) 58 (66) 234 (57) O3 36 (18) 25 (21) 12 (14) 73 (18) US, United States; FNA, fine needle aspiration; FNB, fine needle biopsy *A chi square test was used to compare the three continents. Mo1468 Needle Changes During EUS-FNA: an Attempt to Improve Outcomes Ji Young Bang*, Konrad Krall, Shantel Hebert-Magee, Muhammad K. Hasan, Udayakumar Navaneethan, Robert Hawes, Shyam Varadarajulu Center for Interventional Endoscopy, Florida Hospital, Orlando, FL Background: Despite technological improvements, use of O1 needle during EUS- FNA of individual lesions is not uncommon. Objective: Determine frequency of needle change during EUS-FNA and identify reasons for this occurrence. Methods: Observational study of all patients undergoing EUS-FNA over 18 months. By protocol, all transesophageal/gastric/rectal FNA were undertaken with 22G needle and transduodenal FNA using 25G needle. When core biopsy or sampling of cyst O3cm was required, standard 19G (transgastric) or Flexible 19G (transduodenal) needle was used; smaller cysts were aspirated using 22G needle.outcome measure: Determine frequency and evaluate reasons for use of O1 needle for sampling individual lesions. Results: 1038 patients met inclusion criteria: 25G needle used in 646 patients (62.2%), 22G in 290 (27.9%) and 19G in 102 (9.8%). Lesions were classified as pancreatic in 731 (70.4%), lymph nodes (LN) in 135 (13.0%) and others in 172 (16.6%) needles were used in 1038 lesions; 52 lesions (5.0%) were sampled using O1 needle: 25G needle change in 32 patients (61.5%), 22G in 12 (23.1%) and 19G in 8 (15.4%). Overall frequency of needle change was 5.0% with no difference between pancreatic and non-pancreatic lesions (4.4% vs. 6.5%, pz0.15). 25G NEE- DLE: Of 32 changes, 20 were pancreatic and 12 non-pancreatic (3 LNs, 9 other). In pancreatic FNA, reasons for needle change were non-diagnostic samples in 18 and needle dysfunction in 2. Reasons for non-diagnostic samples in pancreas were mass in the setting of pancreatitis in 13 (72.2%) and associated cyst/small lesion in 5 (27.8%). On change to 19/22G needle, onsite diagnosis was possible in 9 (7 chronic pancreatitis, 1 small mass, 1 cystadenocarcinoma) and indeterminate in 9. Of 12 patients with non-pancreatic masses sampled with 19/22G needle, 4 were GISTs, 3 metastatic cancers, 1 biliary IPMN and non-diagnostic in 4. 22G NEEDLE: Of 12 needle changes, 7 were pancreatic FNA and 5 other sites/lns. In pancreas, following change to 25G needle, diagnosis of cancer was established in 6 of 7 (85.7%) lesions (all O30mm in size); needle change to 19/25G established diagnosis of GIST in 3 of 5 non-pancreatic lesions.19g NEEDLE: Of 8 needle changes, 5 were for pancreatic and 3 for submucosal masses. On change to 25G needle, 4 pancreatic masses (O30mm in size) were diagnosed to be cancer; 1 patient with 40mm pancreatic mass underwent FNA using 22G needle that was suspicious for cancer. In 3 patients with submucosal masses, diagnosis of GIST was made on change to 25G needle in 2 patients and non-diagnostic in 1. Conclusions: Using well-structured algorithmic practice, needle change is required in only 5% of cases with no difference between pancreatic and non-pancreatic masses. Need for needle change was observed more often when pancreatic masses were large or seen in association with chronic pancreatitis. Mo1469 The Usefulness of Endoscopic Ultrasonography-Guided Fine Needle Aspiration Biopsy for Gastric Subepithelial Lesion Hitomi Kikuchi* 1, Takuto Hikichi 2, Tadayuki Takagi 1, Rei Suzuki 1, Jun Nakamura 1, Ko Watanabe 2, Mitsuru Sugimoto 1, Yuichi Waragai 1, Naoki Konno 1, Hiroyuki Asama 1, Mika Takasumi 1, Masaki Sato 1, Katsutoshi Obara 2, Hiromasa Ohira 1 1 Gastroenterology and Rheumatology, Sch. of Med. Fukushima Medical University, Fukushima, Japan; 2 Endoscopy, Fukushima Medical University Hospital, Fukushima, Japan Aim: The usefulness of endoscopic ultrasonography-guided fine needle aspiration biopsy (EUS-FNA) has been widely acknowledged for histopathological diagnosis of gastric subepithelial lesion (SEL). In Japan s consensus guidelines for the management of gastrointestinal stromal tumor (GIST), the adaptation standard of surgery and EUS-FNA for gastric SEL is indicated that tumor diameter is more than 20 mm. However, because GISTs have malignant potential and they are the most numerous among gastric SELs, it is important to perform surgery and EUS-FNA actively for gastric SELs smaller than 20 mm as well. The aim of this study was to examine the effectiveness of EUS-FNA conducted for gastric SELs (especially, smaller than 20 mm). Method: This study examined 140 cases of gastric SELs for which EUS-FNA had been conducted during January December We utilized mainly GF-UC260P or GF-UCT260 (Olympus), and various types of 22G or 19G FNA needles, for example NA-11J-KB (Olympus), EchoTip (Cook Medical) and Expect (Boston Scientific). We retrospectively examined the accuracy of EUS-FNA and prognosis after EUS-FNA. Results: Participants comprised 68 men and 72 women, the average age was 61.0 years. The average number of punctures was 4.4 times (range 1-14), indicating no significant difference as tumor diameter. Rates of collected samples were 91.4% (128/140): 80% for smaller than 20 mm of tumor diameter (nz35), 94.9% for mm (nz99), and 100% for larger than 50 mm (nz6). The EUS-FNA diagnoses were the following: GISTs were 95 cases; leiomyomas, 12; aberrant pancreas, 10; schwannomas, 2; gastric cancer, 1; metastasis of esophageal cancer, 1; and others, 7. Adverse event was seen in one bleeding case (0.7%). In 95 cases diagnosed as GIST by EUS-FNA: surgery cases were 61; Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB431
37 chemotherapy, 1; and follow-up, 33. Among the surgery cases, three were misdiagnosed in EUS-FNA. Based on the final diagnoses, leiomyoma and schwannoma were two and one, respectively. In cases which surgery had been performed, the concordance rate for EUS-FNA diagnosis was 95.3% (61/64). In all, 74 cases were followed up by our institution after EUS-FNA. The average follow-up period was 54 months (7-162 months). All patients except for one case with a metastatic cancer are alive today. Additionally, in cases of GIST, 50 cases were followed up our institution: surgery cases were 36; follow-up, 14. Tumor diameter of follow-up GIST cases were mm, and were almost no change today. Conclusion: EUS-FNA for gastric SEL was useful to determine the course of treatment because of its high diagnostic accuracy and safety. Additionally, it is important to diagnose whether the lesion is GIST or not. It is possible to collect samples in 80%, even if they are smaller than 20 mm, which suggests that diagnosis can be established actively using EUS-FNA. Mo1470 EUS-Guided Fine Needle Aspiration and Fine Needle Biopsy Under on-site Cytopathological Evaluation for Gastric Subepithelial Tumor Jae Pil Han* 1, Su Jin Hong 1, Hee Kyung Kim 2, Yun Nah Lee 1, Tae Hee Lee 1, Hyun Jong Choi 1 1 Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon, Korea (the Republic of); 2 Department of Pathology, SoonChunHyang University School of Medicine, Bucheon, Korea (the Republic of) Background/Aims: Adequate tissue sample for immunohistochemical (IHC) staining is very important in differential diagnosis of subepithelial tumor (SET). Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) using core biopsy needle with reverse bevel was developed to increase the diagnostic yield from trap more core tissue. We aimed to compare the diagnostic yield between EUSguided fine needle aspiration (EUS-FNA) and EUS-FNB in gastric SET under precedent on-site cytological examination. Methods: Between 2012 and 2014, 22 patients with SET in upper GI tract were enrolled prospectively. For the same lesion, EUS-FNA using a 22-gauge aspiration needle (Echotip; Wilson-Cook Medical, USA) and EUS-FNB using a 22-gauge core biopsy needle (Echotip ProCore; Wilson-Cook Medical, USA) were performed respectively. After on-site evaluation for cellularity, cytology using Papanicolaou staining and histology with IHC staining were evaluated in specimens of each procedure. Results: Of 22 SETs, 16 (72.7%) were diagnosed as GISTs, 3 (13.6%) as leiomyomas, 1 (4.5%) as schwannoma, 1 (4.5%) as neuroendocrine tumor, and 1 (4.5%) as ectopic pancreas. Diagnosis from the histology with IHC staining was established in 15 (68.2%) and 18 (81.8%) in EUS-FNA and EUS-FNB, respectively (pz0.514). There was significant difference in median number of needle passes to obtain adequate cellularity in on-site cytological evaluation (2.0 in EUS-FNA vs. 1.0 in EUS-FNB, pz0.008). Conclusions: The diagnostic yield is not significantly different between EUS-FNA and EUS-FNB under precedent on-site cytological evaluation for gastric SET. However, EUS-FNB can decrease number of needle passes for adequate tissue comparing to EUS-FNA. Mo1471 EUS-FNB Is Highly Accurate in Diagnosing Submucosal Lesions - a Prospective Randomized Study Comparing FNA and FNB Per Hedenström* 1, Björn Lindkvist 1, Akif Demir 2, Ola Nilsson 2, Riadh Sadik 1 1 Department of Internal Medicine, Division of Medical Gastroenterology, Gothenburg, Sweden; 2 Department of Clinical Cytology and Pathology, Sahlgrenska University Hospital, Göteborg, Sweden Background: Submucosal lesions (SML) such as GIST tumors are regarded difficult to sample by EUS-FNA. Rapid on-site cytology (ROSE) may improve results. Fine Needle Biopsy (FNB) is an alternative approach. There is however a lack of prospective studies comparing FNA versus FNB on the same lesions. Aim: The aim of this prospective, randomized study was to compare the diagnostic accuracy of FNA and FNB on the same SML. Method: The study was conducted at a tertiary university endoscopy center in West Sweden. Patients referred for an EUS with the suspicion of a GIST tumor were enrolled during September October No puncture was performed if ultrasonography showed a clearly benign lesion such as a lipoma. Other tumors were punctured with both FNA and FNB. Randomization decided which technique to use first. After the first puncture the endoscopist alternated further punctures between FNA and FNB. If available, a cytotechnician was present on-site (ROSE). As far as possible smears and core biopsies were assessed by a study specific cytologist and pathologist respectively. Cellblock technique was performed if the FNA-yield was sufficient. McNemar s test was performed on related samples and Fischer s exact test on independent samples. Results: 62 cases were enrolled and 45 out of those were punctured with FNA and FNB. The mean lesion size of all tumors was 35 mm. ROSE was available in 25/45 (56%) of cases. Distribution of tumors in table 1.The sensitivity of FNB was superior to that of FNA ((23/26, 89 %) vs (17/26, 65%), pz0.03. The accuracy of FNB was also higher compared with FNA (39/ 45, 87 %) vs (27/45, 60 %), pz0.002). The sensitivity of FNA was however much higher if ROSE was available compared to non-rose (14/16, 88 %, vs 3/10, 30 %, pz0.002). Tumors punctured with ROSE was non-significantly larger than tumors punctured without ROSE (39 mm vs 30 mm, pz0.17).analyzing only small tumors (diameter! 30 mm, nz21) the sensitivity was comparable to that of the whole group (nz45), (FNB (19/21, 91%), FNA with ROSE 6/7 (86%) and FNA without ROSE 4/14 (29%)).Regarding positive tumor specific immunohistochemistry (IHC) the difference in sensitivity between FNB and FNA was more pronounced ((23/26, 89 %) vs (13/26, 50 %), pz0.002), but less so if ROSE was available (FNB 15/15, 100 % vs FNA 10/15, 67%, pz0.06).successful assessment of the Ki67%-value of GISTs was achieved in a majority of FNB compared to a minority of FNA (18/26 (69%) vs 6/26, 23%, p!0.001).first puncture modality (FNB vs FNA) did not affect the sensitivity of FNA (pz0.35). Conclusion: FNB is highly accurate and can be recommended as the first line approach when performing EUS-guided sampling on submucosal lesions. Access to ROSE however considerably improves the results of FNA. Distribution of lesions LESION TYPE FREQUENCY, n (%) LESIONS PUNCTURED WITH FNA+FNB GIST 26 (42) 26/26 Leiomyoma 15 (24) 15/15 Lipoma 10 (16) 1/10 Benign ectopic tissue 6 (10) 3/6 Benign submucosal cyst 4 (6) 0/4 Submucosal ectatic 1 (2) 0/1 vessel TOTAL SUM 62 45/62 Mo1472 Feasibility of EUS Guided FNA Without on Site Cytopathologist and Comparison of Core Tissue Attainment With 19 G and 22 G Needle-a Retroprospective Analysis of 196 Cases in a Tertiary Care Unit. Pankaj N. Desai* 1 Gastro Intestinal Endoscopy Centre, Gastro Care, Surat, India; 2 Endoscopy, Surat Institute Of Digestive Sciences, Surat, India Aims: 196 cases referred to our centre from April 2012 to May 2014 were studied retrospectively for feasibility of FNA without an on site cytopatholgist for predicting the positive pick up rate and possibility of obtaining core tissue for IHC staining. In addition simultaneously comparison of core tissue acquisition by 19G and a 22G needle was performed. A protocol was designed where all patients referred for FNA were included and the above mentioned parameters studied retrospectively. Methods: All the 196 cases were subjected to EUS guided FNA using an Olympus EU ME1 echoendoscope. The procedure was performed in left lateral position and under conscious sedation using midazolam and propofol.fna was performed using a 25 G needle for masses beyond the Pylorus. A 22G and 19G needle were used for masses accessible from the stomach. A total number of five passes were made for each case. Also for all lymph nodal masses and sub mucosal masses FNA was performed and in addition core tissue was acquired with a 22 G and a 19 G needle making two passes with each needle and results studied. Total 123 patients with lymph node masses and sub mucosal gastric and duodenal masses were subjected to core biopsy. Conclusions: 1 ) Out of 196 cases 9 cases had poor cellularity and 16 were non conclusive. i.e tissue diagnosis was not possible in 12.7%.2) The tissue diagnosis was possible 87.3 % in absence of an on site cytopathologist.3) Core tissue was obtained in 123 case of which with both the needles a positive diagnosis was obtained in 107 cases ( 86.9 %) and 16 cases failed to revealed significant cellularity (13.1%).4) Out of the 107 positive cases of core biopsies, the biopsies were positive in 85 cases ( 79.4 % ) with a 19G needle with failure credited to blood contamination. With a 22G needle 22 positive biopsies ( 20.6 % ) were obtained and they had less blood contamination.5) Adenocarcinoma of the head of the pancreas was the commonest etiology in pancreatic head masses.6) The most non conclusive cytology was in uncinate process masses ( 33.3%).7) Tuberculous lymphadenopathy was the commonest etiology in lymph nodal masses. Results Indications Adenocarcinoma Koch s NET Lymphoma GIST Sarcoid NC PC Benign Total Pancreatic Head Mass Mediastinal Nodes Abdominal Nodes Gastric Masses AB432 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
38 Indications Adenocarcinoma Koch s NET Lymphoma GIST Sarcoid NC PC Benign Total Duodenal Masses Body and Tail Mass GB Mass Uncinate masses IHC Possible NC - Non Conclusive with adequate cellularity. PC - Poor Cellularity the antrum and median size SD was 19, mm (range: 5-83). Lesions were originated from the submucosa in 29.1%, from the muscularis propria in 39.2% and from the deep mucosa in %6.3. Extraluminal compression was the cause in 18 (7.6 %). Gastrointestinal stromal tumor comprised 80 (33.7%), ectopic pancreas 31 (13.1%), lipoma 26 (11%), leiomyoma 14 (5.9%) and cyst 10 (4.2%) were the EUS diagnosis. Of the lesions endoscopically measured below 5 mm, %55 could not be seen endosonographically. Of the cases having adequate and diagnostic fine needle aspiration material, EUS confirmed presumptive diagnosis in 86.7%. Conclusion: The EUS appears to be very effective in differential diagnosis of gastric SEL, and necessity for FNA is limited to a few cases. Mo1473 Diagnostic Workup for Small Subepithelial Upper Gastrointestinal Tumors Is Inadequate in Guiding Management Joren R. Ten Hove* 1, Niels Van Lelyveld 2, Frank P. Vleggaar 1, Leon M. Moons 1 1 Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands; 2 Department of Gastroenterology, St. Antonius Hospital, Utrecht, Netherlands Background: The occurrence of a subepithelial tumor (SET) of the upper gastrointestinal tract prompts a possible diagnosis of GIST, carrying malignant potential. Current guidelines uphold conservative management as one of the possible strategies for SETs!2cm, necessitating tissue acquisition to reach a definitive diagnosis. Tissue acquisition of SETS!2 cm can be difficult, resulting in long term follow-up of benign SETs without malignant potential. Aim: To assess the currently used tissue sampling techniques for small upper gastrointestinal SETs and their efficacy in daily practice. Methods: All consecutive patients between 2001 and 2013 undergoing an endoscopic ultrasound (EUS) for a suspected SET in either esophagus, stomach or duodenum in an academic and a community hospital were retrospectively studied. Intramural tumors!5cm were included for further analysis, irrespective of the suspicion of a malignant diagnosis or wall layer of origin. All attempts at obtaining a tissue specimen were reviewed and pathology reports for each sample were analyzed and assessed for the presence of a definitive diagnosis. Results: Out of 259 patients who underwent EUS for evaluation of a suspected SET, 143 had a subepithelial tumor! 5cm (39 in esophagus, 91 in stomach, 13 in duodenum) with a mean initial size of 19.1 mm (SD 10.3). Mean age was 60.3 years (SD 12.6) and 83 patients (58%) were male. A total of 197 tissue samples was obtained during endoscopy or EUS. The rate of diagnostic samples was low in both the first 12 months; 23 out of 163 samples (14.1%), as in the follow-up period; 6 out of 34 samples (17.6%). The proportion of diagnostic samples was 17.1% (12/70) for EUS guided fine needle aspiration (EUS-FNA), 14.7% (5/34) for key hole biopsies and 6.3% (5/80) for endoscopic biopsies without further specification. Trucut, fine needle biopsy (FNB) and de-roofing techniques led to a definitive pathologic diagnosis in 2 out of 3 (66%), 3 out of 5 (60%) and 2 out of 3 cases (66.7%), respectively. The proportion of diagnostic samples increased for each subsequent size category: 5.1% (0-1cm), 5.7% (1-2cm), 19.4% (2-3cm), 44.1% (3-5cm). Size % 2cm was a significant predictor of a nondiagnostic biopsy (5.5% vs. 31.4% diagnostic samples, OR 7.8; 95% CI ). Location of the SET was of no influence on obtaining a histologic diagnosis. Assessment of the mitotic index in 50 high-power fields was not possible in any of the obtained tissue samples. No complications were observed in any of the used tissue sampling techniques. Conclusion: The yield of diagnostic tissue sampling of small SETs during EUS or upper endoscopy is disappointingly low, with small size of the tumor being a significant predictor of poor outcome. Trucut and fine needle biopsy show higher outcome, and should be considered as an alternative to FNA. Mo1474 The Role of EUS Examination and EUS-Guided Fine Needle Aspiration Biopsy for Evaluation of Gastric Subepithelial Lesions: a Large Single Center Experience Birol Baysal*, Omar Masri, Ahmet Danalioglu, Ayça Ilbak, Yusuf Kayar, Ali T. Ince, Hakan Senturk Bezmialem University, Faculty of Medicine, Department of Gastroenterology, Istanbul, Turkey Background: The term subepithelial lesion is applied to a mass or bulge covered by normal appearing mucosa identified during standard endoscopy. Endoscopic ultrasonography (EUS) recently became an important modality to evaluate gastric subepithelial lesions (SEL) and their malignant potential. Aim: To clarify the usefulness of the EUS and EUS-guided fine needle aspiration biopsy (FNA) in differential diagnosis of gastric subepithelial lesions. Materials and Methods: Between May 2011 and August 2014, a total of 237 consecutive patients referred for evaluation of a gastric SEL were evaluated by EUS. The age and sex of patients, the location, size, layer of origin and pathological evaluation of the lesions were considered. All EUS examinations were performed using linear or radial echoendoscopes and fine needle aspirations with 22 G needles. Results: Of 237 patients, 62% were female and mean age SD, years. In 54.4% of cases, endoscopic lesions were localized in Mo1475 Clinical Application of EUS-FNA in the Diagnosis of Mediastinal and Intra-Abdominal Lymphadenopathy of Unknown Origin Bin Cheng*, Jinlin Wang Gastroenterology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China Objective: The aim of this study is to evaluate the performance, diagnostic yield, and safety of EUS-FNA for the diagnosis of mediastinal and intra-abdominal lymphadenopathy. Methods: A retrospective study was carried out in the Digestive Endoscopy Center of Tongji Hospital,Wuhan.114 consecutive patients with mediastinal and intra-abdominal lymphadenopathy by imaging studies suggested malignant diseases underwent EUS-FNA from 2010 to The following datas were recorded: age,gender, previous diagnostic procedures and imaging studies, endoscopy findings, sites of lymphadenopathy, echogenicity and size of lymph nodes(lns), cytology results, FC/IC results, procedure-related complications, and follow-up (obtained by phone call if not available in medical records). Result: (1)A total of 114 consecutive patients(mediastinal lymphadenopathy in 42 cases, intraabdominal lymphadenopathy in 72 cases) were included (mean age 49.2 years, range years; men, 78;women,36). Among 114 patients, 113 were with definite diagnosis and 79 obtained correct diagnosis by EUS- FNA(table 1). The disease distribution mainly includes four kinds of diseases: metastasis(46%), lymphoma(13%), reactive nodes(17%) and tuberculosis(14%). No serious complications were observed with the procedure.(2) The clinical features of four kinds of diseases were shown in Table 2.(3) In the 114 patients,40 patients underwent flow cytometry(fcm). Of the 40 patients, 39 patients had a clear diagnosis included malignant lymphoma in 12 cases(b-cell non-hodgkin lymphoma in 11 cases, B-cell Hodgkin s lymphoma in 1 case). The sensitivity, specificity, positive predictive value(ppv), negative predictive value(npv) and accuracy of EUS-FNA combined with flow cytometry for diagnosing lymphoma were respectively 91.7%, 100%, 100%, 96.4%, 97.4%. Conclusion: EUS-FNA represents a safe and minimally invasive method of obtaining tissue from enlarged mediastinal and intra-abdominal nodes.we found that no correlation between border/ shape/echogenic focus and malignancy,and it may not be reliable to identify benign lesions and malignant lesions only through endosonographic appearance of lymph node. EUS-FNA combined with flow cytometry analysis is a safe, cost-effective, sensitive, and specific method for the diagnosis of deep-seated lymphoma. At present our diagnosis yield is lower than the previous reports,but this situation underscores the correct cytologic diagnosis and the use of ancillary testing. We believe that with the application of more advanced ancillary testing, the diagnosis yield of EUS- FNA will be higher,and it will be an optimized choice for the patients with mediastinal and intra-abdominal lymphadenopathy of unknown origin if the pathologist is involved with the procedure. Table 1. Final diagnosis v.s. FNA diagnosis Final diagnosis (FNA diagnosis,%) * Mediastinal nodes Intra-abdominal nodes Total Metastasis 25 (21, 84%) 28 (17, 60.7%) 53 (38, 71.7%) Lymphoma 1 (0, 0%) 14 (14, 100%) 15 (14, 93.3%) Hematologic malignancies** 1 (0, 0%) 2 (1,50%,) 3 (1, 33.3%) Reactive nodes 4 (4, 100%) 16 (15, 93.8%) 20 (19, 95.0%) Tuberculosis 8 (2, 25.0%) 8 (5, 62.5%) 16 (7, 43.8%) Fungal diseases 1 (0, 0%) 2 (0, 0%) 3 (0, 0%) Castleman s Disease 2 (0, 0%) 1 (0, 0%) 3 (0, 0%) Undiagnosed 0 (0, 0%) 1 (0, 0%) 1 (0, 0%) Total 42 (27, 64.3%) 72 (52, 72.2%) 114 (79, 69.3%) *FNA diagnosis case numbers and its ratio vs. final diagnosis were given in parentheses. ** Hematologic malignancies refers to non-lymphomahematologic malignancies Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB433
39 Table 2. clinical features Metastasis lymphoma Reactive nodes Tuberculosis P value gender(male/female) 43/10* 10/5 13/7 4/12* <0.05 mean age(year,xs) * * <0.05 size(mm,xs) * * * <0.05 border (sharp /fuzzy) 45/8 14/1 17/3 10/6 >0.05 fusion(yes/no) 11/42 8/7* 1/19* 6/10 <0.05 echogenic focus(yes/no) 8/45 0/15 2/18 5/11 >0.05 echogenicity(homogeneous/ 25/28 13/2* 10/10 5/11* <0.05 heterogeneous) Shape(round /irregular) 49/4 15/0 20/0 16/0 >0.05 * mark refers to the group difference was statistically significant Mo1476 Endoscopic Ultrasound-Guided Visualization of Celiac Ganglia and Celiac Ganglia Neurolysis: Results of a Clinical Cross-Sectional and Human Cadaver Study Wouter Kappelle* 1, Ronald Bleys 2, A. J. M. Van Wijck 3, R. Stellema 3, Peter D. Siersema 1, Frank P. Vleggaar 1 1 Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands; 2 Anatomy, University Medical Center, Utrecht, Netherlands; 3 Anesthesiology, University Medical Center, Utrecht, Netherlands Introduction: Endoscopic ultrasound guided celiac ganglia neurolysis (EUS-CGN), which is performed by injecting ethanol in individual celiac ganglia, has recently been introduced as an alternative to celiac plexus neurolysis. However, there is little evidence that the structures targeted during EUS-CGN are indeed celiac ganglia and that selective ethanol injection into ganglia is feasible. Aims: To assess the proportion of patients in which ganglia can be visualized with EUS, to evaluate whether these structures are indeed celiac ganglia and to visualize the local spread of ethanol after EUS-CGN. Methods: In 100 consecutive patients (44 male [44%], median age 60, IQR 45-68) undergoing linear EUS, ganglia were sought and their characteristics recorded. Secondly, a linear echo-endoscope was placed in the region next to the celiac trunk in a prosected human cadaver. A hypodermic needle was inserted into a ganglion after identification and the tissue surrounding the needle was removed, dissected to visualize the ganglion and subsequently sectioned and stained. Finally, EUS-CGN was performed with ethanol 96%, mixed with orange dye, in a nonembalmed human cadaver. Thereafter, the entire region around the celiac plexus was removed and consecutive transverse sections were obtained with a heavy duty cryomacrotome, whilst taking high-quality pictures every 75mm. Afterwards, a 3Dreconstruction was used to obtain sagittal and coronal images. Results: In total, 211 ganglia were detected in 86/100 patients. Median number of ganglia was 2 (range 1-9), median size of the long and short axis were 6.2 mm (IQR mm) and 2.8 mm (IQR mm), respectively. Most often, the ganglia were located anteriorly (nz65, 31%), left (nz64, 30%) or anteriorly and left (nz75, 36%) of the celiac trunk. Histology of the dissected region in the cadaver showed numerous nerve cell bodies around the needle and no other structures with comparable echogenic characteristics, such as lymph nodes. In total, two ganglia were visualized with EUS in the nonembalmed cadaver and both were injected with 1mL of ethanol under EUS-guidance using a 25G FNA-needle. More than 2200 images were taken during transverse sectioning with the microtome. 3D-reconstruction showed spreading of the dye in the celiac region, well beyond the ganglia. In total, a spread of 80 x 70 x 53 mm was seen. Conclusion: Using EUS, it is possible to visualize celiac ganglia in the majority of patients, most commonly anteriorly and to the left of the celiac trunk. Histology from a cadaver confirmed that the visualized structures are indeed celiac ganglia. Ethanol may spread well beyond the injected celiac ganglia after EUS-CGN, even when using just 1 ml per ganglion, thus effectively resulting in a celiac plexus neurolysis. Therefore, it is doubtful whether selective celiac ganglia neurolysis is feasible. Mo1477 Pain Relief in Pancreatic Cancer: Can the Outcomes of EUS- Guided Celiac Plexus Neurolysis (EUS-CPN) Be Improved? Muhammad K. Hasan* 1, Ji Young Bang 1, Bryce Sutton 2, Udayakumar Navaneethan 1, Amy L. Logue 1, Robert Hawes 1, Shyam Varadarajulu 1 1 Center for Interventional Endoscopy, Florida Hospital, Orlando, FL; 2 HSR&D Center of Innovation on Disability and Rehabilitation Research, James A. Haley VA Hospital, Tampa, FL Background: Although EUS-CPN is routinely performed for palliation of pain in pancreatic cancer, the technique yields short-term pain relief in only 50% of patients. Technique modifications such as injection directly into ganglia, bilaterally and near SMA have been evaluated but with varied results. Some reports suggest that vital sign changes during injection may predict outcome but this hypothesis has not been fully tested. Aim: To correlate the relationship between intra-procedural vital sign changes and clinical outcomes in patients undergoing EUS-CPN for pain relief in pancreatic cancer. Methods: Prospective study of all patients with advanced pancreatic cancer undergoing EUS-CPN for palliation of pain. EUS was performed under deep sedation and patients underwent single injection of 10ml 0.25% bupivacaine and 20ml 98% dehydrated alcohol using 19/22G needle at one side of celiac trunk. Injection was performed over 3 mins and vital signs were recorded throughout the procedure. Intra-procedural heart rate change of O15 beats/min was considered clinically relevant and patient was categorized as vital sign change. Pain and quality of life (QOL) were assessed using visual analog scale (VAS) (scale 0-10, 0Zno pain, 10Zmaximum pain), brief pain inventory (BPI) (scale 0-10, 0Zno pain/interference, 10Zmaximum pain/interference), PAN26 and C30 instruments (scale 0-100, 0Zgood function/no symptoms, 100Zpoor function/severe symptoms) that were completed pre-procedure and at weeks 2, 4 and 8. A research nurse blinded to intra-procedural data obtained follow-up on all patients. Main outcome measure was to assess pain and QOL between vital sign change and no change groups. Results: Of 51 patients enrolled over 12 months, 26 patients had no change and 25 showed vital sign changes. There was no significant difference in patient demographics, tumor stage/characteristics, pre and post-procedure narcotic use, post-procedure adverse events (14.4 vs. 9.2%, pz0.072) or survival (pz0.495) between the cohorts.pain and QOL: While there was no significant difference at 2 and 4 week follow-up, at 8 weeks, vital sign change cohort experienced less pain (median VAS score 4 vs. 5, pz0.042), with less interference at work (median 5 vs. 7, pz0.021), relationships (median 5 vs. 6, pz0.008) and sleep (median 5 vs. 6, pz0.048) when compared to no change cohort. Vital sign change cohort also reported significantly higher QOL in C30/PAN26 instruments for nausea/vomiting (49.2 vs. 65.6, pz0.004), pain (38.1 vs. 53.5, pz0.002), body image (36.9 vs. 49.2, pz0.035), financial status (32.5 vs. 48.7, pz0.020) and weight loss (46.4 vs. 65.7, pz0.007) compared to no change cohort. Conclusions: As patients with intra-procedural vital sign changes experienced better pain relief and QOL, this observation must be further explored in order to improve the technique and outcomes of EUS-CPN. Mo1478 Routine Staging With Endoscopic Ultrasound in Patients With Esophageal Cancer and Dysphagia Rarely Impacts Treatment Decisions Sara Mansfield* 1, Samer El-Dika 2, Somashekar G. Krishna 2, Jon P. Walker 2, Kyle A. Perry 1 1 General and Gastrointestinal Surgery, Ohio State University Wexner Medical Center, Columbus, OH; 2 Gastroenterology, Hepatology, and Nutrition, The Ohio State University Wexner Medical Center, Columbus, OH Introduction: Endoscopic ultrasound (EUS) has been routinely employed for the locoregional staging of esophageal cancer. One important aspect of clinical staging has been to stratify patients to treatment with neoadjuvant chemoradiation or primary surgical therapy, with patients with T3 tumor stage or lymph node involvement receiving neoadjuvant therapy. We hypothesized that EUS may have a limited impact on clinical decision making in patients with dysphagia and obstructing esophageal masses. Methods: We tested this hypothesis in a retrospective cohort study of patients undergoing EUS for staging of esophageal cancer between 2009 and 2014 (nz220). Patients without dysphagia (nz82) were excluded. Patient demographics, endoscopic tumor characteristics, presence of dysphagia, sonographic staging, and post-eus therapy were recorded. Pathologic staging for patients who underwent primary surgical therapy was also recorded. Locally advanced disease was definedasatleastt3orn1,asthese patients are typically treated with neoadjuvant therapy. Results: EUS was performed on 138 patients with dysphagia for staging of esophageal cancer during the study period. Patients had an average age of years with an average BMI of kg/m 2, and 86.2% of patients were male. At endoscopy, 128 (94%) patients had esophageal adenocarcinoma, 96 (70%) had partially obstructing lesions, 25 (18%) had completely obstructing lesions, and 17 (12%) had non-obstructing tumors. Overall, 128 (93%) patients had clinical staging indicative of locally advanced disease. Of the 10 patients with early stage via EUS, 6 underwent primary surgical resection for which pathologic staging demonstrated locally advanced disease with lymph node involvement in 4 of these patients. In 121 patients with obstructing lesions, 96% had EUS staging indicative of locally advanced disease, compared to 71% of the 17 patients with non-obstructing tumors (p!0.01). Three patients with obstructing lesions and early stage via EUS underwent primary surgical resection, and 2 were found to have locally advanced disease. Overall, 132 (96%) patients with dysphagia were found to have locally advanced disease by sonographic or pathologic staging. For patients with dysphagia and obstructing tumors, locally advanced or metastatic disease was identified in 98% of patients in this series. Conclusion: An overwhelming majority of patients presenting with dysphagia at the time of esophageal cancer diagnosis had an EUS that demonstrated at least locally advanced disease. The present study supports the hypothesis that endoscopic ultrasound may be of limited benefit for staging esophageal cancer in patients with dysphagia, particularly in the setting of an obstructing mass lesion. AB434 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
40 Mo1479 Staging of Esophageal and Junctional Cancer: Low Accuracy for EUS Tool in T2 N0 Patients Germana De Nucci* 2, Emanuele Dabizzi 1, Maria C. Petrone 1, Sabrina G. Testoni 1, Davide Bona 3, Luigi Bonavina 3, Pier Alberto Testoni 1, Paolo G. Arcidiacono 1 1 Gastroenterology and Gatrointestinal Endoscopy Unit, Division of Experimental Oncology, IRCCS San Raffaele Scientific Institute, Vita- Salute San Raffaele University, Milan, Italy; 2 Gastroenterology and Digestive Endoscopy, G. Salvini Hospital, Milan, Italy; 3 Division of General Surgery, IRCCS Policlinico San Donato, University of Milan, Milan, Italy Background & Aim: Despite the poor prognosis of esophageal carcinoma (EC), the stage of the disease correlates with the length of survival and recommended treatment. Accurate staging of EC is important since it directs further management. After distant metastases have been ruled out by CT scanning or PET-CT, Endoscopic Ultrasound (EUS) is the best available tool in the preoperative locoregional staging, being able to define the depth of tumor invasion and to visualize and even sample locoregional lymph nodes. Accurate staging is important to define T2N0 cancers, which can proceed directly to surgery. When compared to surgical pathology, EUS showed to have about 85 % of accuracy in staging tumor depth and about 75 % in detecting regional lymph node metastases. Aim of the present study was to report a single high volume center s experience with EUS staging in a rare subset of patients with T2N0 esophageal cancers, evaluating the accuracy of EUS staging for T2N0 tumors. Materials & Methods: We conducted a retrospective study from our database of patients, enrolled prospectively, that underwent EUS for staging EC between January 2010 and August We identified patients with T2N0 tumors who underwent surgical resection. The preoperative EUS staging (ctnm) was then compared to surgical pathology (ptnm) results to evaluate accuracy. Results: 509 patients underwent EUS for staging of EC. Of these, 43 patients (33 men, mean age 67 years) received a diagnosis of ct2n0 disease by EUS. Surgical resection of EC was performed after a mean of 11 days post-eus. When compared to final pathologic outcomes, 40 % of patients (17/43) were evaluated correctly and referred for appropriate therapy, 49 % of patients (21/ 43) were understaged by EUS and 12 % of patients (5/43) were overstaged. Among the 21 understaged patients, understaging occurred due to tumor depth in 6 patients (29 %), nodal involvement in 7 patients (33 %) and both in 8 patients (38 %). The 5 overstaged patients had a histological T1b stage, without nodal involment. EUS showed an accuracy of 65 % in staging for tumor depth and of 82 % in staging for nodal involvement. Positive predictive value of EUS diagnosis of ct2n0 EC was 40 % (17 pt2n0/43 ct2n0). Conclusions: In this challenging group of patients with T2N0 tumors, EUS understaged EC in 49 % of cases resulting in surgical resection when neoadjuvant chemoradiation may have been beneficial. This underline that T2N0 EC is a branching point in the clinical decision making for the management of EC and that accurate clinical staging in patients with T2N0 EC is of paramount importance. Further improvement in EUS imaging quality at various depth is needed. Mo1480 Accuracy of Standard mhz Endoscopic Ultrasound for Loco- Regional Staging of Oesophageal Malignancy- a Retrospective Analysis Shadab Nayeemuddin, Elizabeth Darling, Senthil V. Murugesan, Venkataswamy N. Mahesh* Gastroenterology and Hepatology, Blackpool Victoria Hospital, Blackpool, United Kingdom Introduction: Endoscopic Ultrasound (EUS) is currently an important modality used in the staging of oesophageal cancer. However systematic reviews have reported wide variations in locoregional - T and N staging - accuracy of EUS 1. This variability is attributed to multiple factors including the frequency of the echoendoscope (5-20MHz), operator experience and technique, tumour related factors particularly non-traversibility and use of miniprobes. In addition, published literature does not take into account the time lag between staging EUS and resection especially in the setting of concomitant neoadjuvant chemotherapy. Aim: To evaluate the accuracy of T and N staging of oesophageal cancer using standard MHz echoendoscope in our centre. Material and Methods: Retrospective review of oesophageal cancer cases registered in the local upper GI cancer database and Somerset Cancer registry for the Lancashire and South Cumbria cancer network (January December 2013). Staging EUS was performed at a single centre (Blackpool Teaching Hospitals) by four different operators using Olympus prosound alpha 5 radial (13.8mm outer diameter) and linear (14.6mm outer diameter) echoendoscopes. EUS staging was compared with final histopathological (p) staging of tumours. Results: 405 patients with oesophageal cancers were identifed, 141 had EUS staging. 47 [39 male (83%); mean age 70 (age range 45-85)] had a final pathological staging available - surgical resection in 42 (89%) and endoscopic mucosal resection (EMR) in 5 (11 %). The remaining 94 patients were either unfit for resection or had palliative treatment only. Final p staging confirmed adenocarcinoma in 38 (81%), sqaumous cell carcinoma in 7 (15%) and poorly differentiated in 2 patients (4%). 30 (64%) patients had neoadjuvant chemotherapy. 10 patients (21%) had endoscopically non-traversible tumours. Overall sensitivity and diagnostic accuracy of EUS for T staging was 87% and 70% respectively, which falls to 67% and 49% respectively when corrected for neoadjuvant chemotherapy. Similarly overall sensitivity and diagnostic accuracy of EUS for N staging was 61% and 49% respectively, which falls to 40% and 38% respectively following neoadjuvant chemotherapy. None of the patients had FNA of local lymph nodes. Discussion and conclusions: These results confirm that EUS has an acceptable overall accuracy for locoregional staging, especially T1 and T3 stage tumours. Overall accuracy of N staging is poor since routine FNA was not performed (only morphological criteria used). Limitations of study include time lag (mean 16.4 weeks) between EUS and resection and neo-adjuvant chemotherapy down staging of tumours. We recommend considering FNA of all suspicious lymph nodes instead of using morphological features alone.references: 1. Puli SR, et al. World J Gastroenterol 2008; 14(10): T and N staging of Oesophageal cancers T stage p T stage EUS T stage: n (% match with p T stage) N stage p N stage EUS N stage: n (% match with p N stage) Tx 1 0 (0%) N (74%) T (69%) N1 7 6 (70%) T2 4 0 (0%) N2 9 1 (0%) T (96%) N3 6 0 (0%) T4 3 0 (0%) Mo1481 Role of the Combined Endobronchial and Transesophageal Approach by Using Single Ultrasound Bronchoscope for Diagnosis of Mediastinal Lymphadenopathy Alena Strunina* 1, Roman Kuvaev 1, Sergey V. Kashin 1, Alla Levina 2, Viktoriya Chernyaeva 2, Nikolay Akhapkin 3 1 Endoscopy, Yaroslavl Regional Cancer Hospital, Yaroslavl, Russian Federation; 2 Cytology, Yaroslavl Regional Cancer Hospital, Yaroslavl, Russian Federation; 3 Administration, Yaroslavl Regional Cancer Hospital, Yaroslavl, Russian Federation Introduction: Morphological evaluation of mediastinal masses and lymph node is essential for diagnostic confirmation and treatment planning of patients (pts) with mediastinal abnormalities. Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) are minimally invasive procedure that provides material for the cytological diagnostic workup. The combined approach reduces the need for an additional equipment, the operating costs, and the duration of the procedure. However it could be difficult to select the order of preference if both of the techniques are available. Aims & Methods: The aim was to determine the diagnostic value of EBUS-EUS combined approach by using single ultrasound bronchoscope for evaluation mediastinal lymphadenopathy. EUS FNA and EBUS TBNA (Olympus Exera II BF-UC160F, Olympus 21g needles) were compared in 166 patients for tissue diagnosis from enlarge (O0.9cm) 7 and 4L group lymph nodes. 110 lesions were sampled from the respiratory tract under moderate sedation as first step and for 56 lesions fine needle aspiration were performed initially from the esophagus under local anesthesia. There was used rapid on-site evaluation of the fine needles aspirates. In cases when rapid on-site evaluation showed no diagnostic results after the primary EUS-FNA (8 pts) then EBUS-TBNA was performed. Results: Diagnosis was proved in 87.3% of cases in EBUS-TBNA group and in 85.7% of cases in EUS-FNA group. Definitive morphology diagnosis was made in 96.4% by the combined approach with rapid on-site evaluation of the fine needles aspirates. Conclusion: Two procedures can be performed with single ultrasound bronchoscope and combine approach with rapid on-site evaluation of the fine needles aspirates has better diagnostic value than either alone. But EUS-FNA with ultrasound bronchoscope is ease, safety and doesn t request moderate sedation. Therefore it can be performed for patients for tissue diagnosis from enlarge 7 and 4L group lymph nodes as first step of examination. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB435
41 Mo1482 The Role of Surveillance Endoscopic Ultrasound (EUS) After Endoscopic Treatment of Intramucosal Cancer (IMC) in the Setting of Barrett s Esophagus (Be) Mariano Gonzalez-Haba Ruiz*, Vani J. Konda, Ann Koons, Uzma D. Siddiqui, Andres Gelrud, Irving Waxman Center for Endoscopic Research and Therapeutics, The University of Chicago Medicine, Chicago, IL Background: Endoscopic treatment, including endoscopic mucosal resection (EMR) of visible lesions and radiofrequency ablation (RFA) of the remainder BE epithelium, has become standard of care in the management of IMC in patients with Barrett s esophagus (BE). The risk of lymph node metastases (LNM) among patients with IMC is estimated to be less than 2%. EUS may be performed at evaluation to exclude LNM. After endoscopic therapy, regular endoscopic follow up is required to detect potential recurrence. There is a lack of consensus of whether follow up of patients with IMC should include EUS for detection of LNM. The aim of this study is to evaluate the value of EUS added to endoscopy in the setting of follow up after endoscopic treatment for IMC in patients with BE. Methods: A retrospective chart review was conducted utilizing a prospectively collected database to select cases. Cases were identified as patients who were referred for BE associated neoplasia and were diagnosed with IMC, either by endoscopic biopsy or EMR from August 2003, through May All patients underwent endoscopic therapy either with complete endoscopic resection of the BE or with hybrid therapy (EMR of visible lesions and RFA and/or Cryoablation of the remainder epithelium). Patients in which an EUS was performed in follow up at least one year after initial diagnosis were selected for analysis. Results: Out of 59 patients with IMC who completed endoscopic therapy, 50 patients fulfilled inclusion criteria (39 Male, median age 70, mean BE length, 4.7cm). Ten were diagnosed with IMC by initial biopsy and 40 were diagnosed by EMR specimen. Median follow up time from diagnosis was 46.5 months (range ). During this follow up period, a total of 165 EUS (mean 3.3) were performed. Confirmed lymph node metastasis (LNM) was found in two patients on EUS during follow up. One patient (2%) presented with a positive lymph node for metastatic esophageal adenocarcinoma at 1 year after endoscopic treatment associated with buried neoplasia. Another patient had LNM found by EUS from a non-gastrointestinal malignancy without any evidence of recurrence of BE associated neoplasia. In 5/ 50 patients (10%) enlarged lymph nodes were found on EUS during follow up without evidence for malignancy after FNA sampling and/or by subsequent exams. One patient had an incidental newly diagnosed malignancy (dendritic cell tumor) and 5/50 patients had other benign findings, including choledocolithiasis and gallbladder stones. Conclusions: The rate of LNM from esophageal neoplasia in patients who were endoscopically treated for IMC is very low. Although EUS has the potential to demonstrate significant incidental pathology, its role in serial examinations during follow up after treatment of IMC is limited. Mo1483 Endoscopic Stricturoplasty: a Novel Technique for Symptomatic and Refractory Upper Gastrointestinal Strictures Syed I. Rahman* 3, Pavan Tummala 2, Banke Agarwal 1 1 Division of Gastroenterology and Hepatology, Saint Louis University School of Medicine, Saint Louis, MO; 2 Saint Louis University School of Medicine, St. Louis, MO; 3 Internal Medicine, Medical College of Wisconsin, Milwaukee, WI Refractory and symptomatic strictures often require repeated dilations producing short partial and brief symptom improvement and associated with significant aggregate risk of complications. We report on our experience with patients with intractable and symptomatic strictures requiring frequent balloon dilations that were treated with endoscopic stricturoplasty. Endoscopic stricturoplasty comprised making multiple radial cuts with a needle knife in a circumferential manner at the stricture site to cut through the scar tissue. Prior to stricturoplasty, the wall thickness at the stricture site was assessed with endoscopic ultrasound using through the scope high frequency probes. Fifteen patients with symptomatic esophageal (NZ9), duodenal (NZ5), and gastric (NZ1) strictures who underwent endoscopic stricturoplasty at our institution since 2009 were identified. Overall, 80% (NZ12/15) of patients indicated a marked improvement in symptoms, specifically dysphagia. Table 1 summarizes the symptom profile before and after (follow-up ranging from 9-26 months) endoscopic stricturoplasty. There were no procedural related complications or adverse events in this cohort. Endoscopic stricturoplasty using radial superficial needle knife cuts performed by a proficient endoscopist can provide marked and durable improvement in dysphagia in patients with strictures refractory to dilations and should be considered as a treatment option. Further evaluation of this technique is needed in other major endoscopy centers and in clinical trials. Esophageal stricture - immediately prior to, immediately following and 6 weeks following endoscopic stricturoplasty. Patient characteristics and clinical follow-up with endoscopic stricturoplasty Age Sex Esophageal or Duodenal Strictures Stricturoplasty Sessions Eating pre Treatment Eating post treatment Feeling better post treatment Residual Dysphagia post treatment Weight gain post treatment 61 F Duodenal 3 Liquid Unrestricted Yes Present Yes 67 F Duodenal 1 Small meals Unrestricted Yes Absent None 62 M Gastric 1 Liquid Unrestricted Yes Absent Yes 86 F Esophageal 4 Unable to eat Unrestricted Yes Absent Yes 71 F Esophageal 3 Liquid/soft food Unrestricted Yes Absent None 75 F Esophageal 1 Soft food Unrestricted Yes Absent Yes 78 M Esophageal 1 Any Unrestricted Yes Absent None 55 M Esophageal 3 Liquid Unrestricted Yes Present None 50 F Duodenal 3 Liquid Diverticulitis Diet Yes Absent None 75 M Esophageal 2 Any Unrestricted Yes Absent None 58 F Duodenal 1 Small meals Unrestricted Yes Absent None 65 M Duodenal 3 2 small meals Unrestricted Yes Absent None per day 67 F Esophageal 3 Liquid/soft food Unrestricted Yes Absent Yes 71 M Esophageal 1 Small meals Slower pace Yes Present None 61 M Esophageal 3 Liquid/soft food Unrestricted Yes Absent Yes AB436 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
42 Mo1484 Endoscopic Ultrasound (EUS) Is Superior to Esophagogastroduodenoscopy (EGD) and Esophageal Capsule Endoscopy (ECE) for Varices Screening Tsion Abdi* 1, Danielle Marino 3, Avlin B. Imaeda 1, Chuhan Chung 1, Petr Protiva 1, Anil B. Nagar 2,1 1 Digestive Diseases, Yale University School of Medicine, New Haven, CT; 2 Digestive Diseases, West Haven VA, West Haven, CT; 3 Gastroenterology, University of Rochester, Rochester, NY Background: EGD is the standard of care for the diagnosis of esophageal varices while esophageal capsule endoscopy (ECE) is an accepted alternative. Prior studies have not evaluated endoscopic ultrasound (EUS) compared to EGD and ECE in screening for esophageal varices. Aim: To compare the performance of EGD, ECE, and EUS in diagnosing esophageal varices. Methods: A single center prospective blinded study of consecutive patients with cirrhosis referred for variceal screening. Patients underwent three procedures at one visit. ECE with PillCam was performed first and followed by EGD under conscious sedation. An EUS was then done using a TTS 20MHZ probe performed by a different endoscopist. ECE consultant was blinded to the results of the other procedures. Varices were graded as following: EGD small v/s large, ECE small v/s large and EUS by measuring size in mm. SPSS software was used to calculate sensitivity, specificity, predictive value and compare groups for agreement. Results: 52 patients were enrolled in the study. 48 patients completed all three tests. Four patients were excluded due to inability to perform all three tests due to dysphagia, food in stomach and inability to sedate. The mean age was 60 and the average MELD score was 10.8 (range of 7 to 20). Varices were detected by EUS, EGD and ECE in 44, 32, and 38 patients, respectively. Using EUS as a gold standard EGD had a sensitivity of 72.7%, specificity 100%, positive predictive value 100% and negative predictive value 25% respectively. ECE had a sensitivity 79.5%, specificity 25%, positive predictive value 92% and negative predictive value of 10% respectively. The kappa value for agreement between EUS and EGD was.308, denoting fair agreement. The kappa value for agreement between EGD and ECE was.483, denoting fair agreement. The kappa value for agreement between EUS and ECE was.027, denoting poor agreement. EUS varices size was!2mm in 17 patients, between 2mm and 3mm in 18 patients and O3mm in 9 patients. Both EGD and ECE identified!50% of the varices less than 2 mm in size on EUS compared to 85% of varices more than 2 mm in size on EUS (p value equals!.009). Procedures were safe with few complications, 1 patient had bleeding post EGD and 2 patients experienced aspiration with ECE. Conclusions: This study prospectively identifies EUS as the most sensitive test to screen for varices. Further studies are necessary to determine if finding on EUS may reflect changes in early clinically compensated portal hypertension. Mo1485 Comparison of Direct Endoscopic Injection (DEI) and EUS-Guided Fine Needle Injection (EUS-FNI) of 2-Octyl-Cyanoacrylate for Treatment of Gastric Varices Ji Young Bang* 1, Mohammad A. Al-Haddad 2, Michael V. Chiorean 3, Naga P. Chalasani 1, Paul Y. Kwo 1, Marwan Ghabril 1, Marco A. Lacerda 1, Saurabh Agrawal 1, Howard Masouka 1, Raj Vuppalanchi 1, Eric S. Orman 1, Margaret S. Sozio 1, Samer Gawrieh 1, Craig Lammert 1, Suthat Liangpunsakul 1, John M. Dewitt 1 1 Gastroenterology-Hepatology, Indiana University, Indianapolis, IN; 2 Gastroenterology & Hepatology, Cleveland Clinic, Abu Dhabi, United Arab Emirates; 3 Digestive Diseases institute, Virginia Mason Medical Center, Seattle, WA Background: Gastric varices (GV) can bleed in 10-70% of patients and are associated with significant morbidity and mortality. Endoscopic therapy with 2-octyl cyanoacrylate (CYA) may be performed by direct endoscopic injection (DEI) or more recently by fine needle injection (FNI) under EUS guidance. However, impact of EUS-guided FNI of GV compared to DEI is unknown. Aim: To compare the incidence of rebleeding and adverse events associated with DEI and EUS-FNI of CYA for GV. Methods: Consecutive patients at a single tertiary hospital who underwent DEI with CYA for primary prophylaxis or active/recent GV bleeding between 2/ 2006 and 4/2012 were initially identified. These patients represent our initial experience with endoscopic therapy of GV. To improve outcomes, DEI was abandoned in 2012 in favor of EUS-FNI. Results of FNI using CYA between 1/2013 and9/2014forthesamepatientpopulationwere prospectively recorded. Patient characteristics, procedure details and outcomes between the two groups were analyzed. Primary outcome: rate of GV rebleeding %30 (early) or O30 days after (late) therapy. Secondary outcomes: 1) no. of treatments needed for GV eradication; 2) incidence of adverse events (AEs). DEI and EUS-FNI were performed with 23 gauge and 19 gauge needles respectively, in mL aliquots. No coils were used. In the absence of early rebleeding, follow-up endoscopy and possible repeat therapy in both groups were performed within 3 months and periodically thereafter to eradicate GV. Eradicated GV: 1) direct endoscopy showed no visible GV or 2) residual GV were hardened on catheter palpation or exhibited minimal/ absent flow by Doppler EUS. AEs were classified as mild, moderate or severe (CottonPetal.,GIE2012).Results:31patients underwent EUS-FNI (38 injections) and 40 received DEI (53 injections). Patient demographics and procedure findings/outcomes are listed in the Table. There was no significant difference in overall incidence of GV rebleeding after EUS-FNI (nz2; 7.7%) and DEI (nz9, 23.7%; 16.0% [95% CI ] for the difference in rebleeding rate between the treatment groups). Early GV rebleeding occurred in both EUS-FNI patients and 6 of 9 DEI patients. Recurrent all-cause GI bleeding was higher in DEI group (57.9 vs.22.6%,pz0.004). Overall AEs were significantly higher in EUS-FNI group (47.4 vs. 13.2%, p!0.001), however the incidence of moderate/severe AEs (2 PEs, 2 splenic infarcts in EUS-FNI; 4 bleeding during injection in DEI) were similar. Conclusions: CYA injection of GV by both endoscopic and EUS approaches appear to be safe and effective with similar high treatment success rates. Both techniques may lead to rare, potentially serious AEs. Further studies are needed to determine the long-term impact of EUS-FNI in the treatment of GVs. Comparison of FNI and DEI groups EUS (n[31) DEI (n[40) p-value Age (years) Median (IQR) 58 (46-67) 57 ( ) Gender (n, %) Female 14 (45.2) 11 (27.5) Etiology of GV (n, %) Cirrhosis 26 (83.9) 38 (95.0) Other 5 (16.1) 2 (5.0) Etiology of cirrhosis (n, %) Hepatitis C 9 (34.6) 12 (31.6) Alcohol 5 (19.2) 8 (21.1) NASH/Cryptogenic 8 (30.8) 14 (36.8) Other 4 (15.4) 4 (10.5) MELD Median (IQR) 13 (9-15) 16.5 (12-22) Reason for eradication (n, %) Primary prophylaxis 5 (16.1) 2 (5.0) Secondary prophylaxis Active bleeding 1 (3.2) 5 (12.5) Stigmata 10 (32.3) 25 (62.5) GV type (n, %) IGV1 15 (48.4) 3 (7.5)!0.001 GOV1 2 (6.5) 6 (15.0) GOV2 14 (45.2) 30 (75.0) Largest GV size (mm) Median (IQR) 10 (7-13) 10 (10-12) CYA volume injected (ml) Median (IQR) 2 (1.5-3) 3 (3-3)!0.001 No. of sessions for eradication 1 24 (77.4) 30 (75.0) /3 7 (22.6) 10 (25.0) Follow-up (days) Median (IQR) 238 (95-378) 362 ( ) GV rebleed (n, %) Overall 2 (7.7) 9 (23.7) Early 2 (7.7) 6 (15.8) Late 0 3 (7.9) All cause GI bleed (n, %) Overall 7 (22.6) 22 (57.9) Early 5 (16.1) 10 (26.3) Late 2 (6.5) 12 (31.6) Adverse events (n, %) Overall 18 (47.4) 7 (13.2)!0.001 Mild 14 (36.8) 3 (5.7) Moderate/Severe 4 (10.5) 4 (7.5) Mo1486 The Diagnostic Utility of Endoscopic Ultrasonography in Assessing the Depth of Tumor Invasion in Early Gastric Cancer Fang Yao* 1, Aiming Yang 1, Dongsheng Wu 1,XiWu 1, Tao Guo 1, Weixun Zhou 2, Xinghua Lu 1 1 Gastroenterology, Peking Union Medical College Hospital, Beijing, China; 2 Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China Objective: To evaluate the role of endoscopic ultrasonography (EUS) in assessing the depth of tumor invasion in early gastric cancerand and to analyze the factors affecting the accuracy of EUS. Methods: This retrospective study enrolled 59 cases of histologically confirmed early gastric cancer who received pre-treatment EUS for Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB437
43 predicting the depth of invasion from Mar 1 st, 2010 to Dec 31th, 2012 in PUMCH. All patients underwent endoscopic or surgical resention after EUS. Assessed the diagnostic sensitivity, specificity and accuracy of EUS by comparing the pre-treatment EUS results with the postoperative histopathological findings. The clinico-pathological factors may influencing the accuracy of EUS were also analyzed. Results: 59 lesions were evaluated by EUS for 59 patients (39 males and 20 females, mean age: years old). Among these lesions, 10 cases located in the upper 1/3 stomach, 13 in the middle 1/3 and 27 in the lower 1/3. The maximal diameters of lesions distributed from 0.7cm to 5.5cm, and 21 lesions were bigger than 2.0cm in diameter. For the macroscopic type, 30 cases showed as 0-IIc, 13 cases were 0-IIa. 49 lesions were confirmed by histopathologic exam to be limited within mucosal layer (M) and the rest 10 invaded to the submucosal layer (SM). The overall diagnostic sensitivity, specificity and accuracy of EUS for the depth of early gastric cancer invasion were 79.7%, 81.4% and 79.7%, respectively. (M: sensitivity 66.1%, specificity 80.0%, accuracy 79.7%, SM: sensitivity 80.0%, specificity 81.6%, accuracy 81.4%, there were no obvious diference between the two groups). The overgrading rate was 16.9%, which mainly happened in leisons located in upper third (20.0%) and middle third (27.3%),with macroscopic elevated type (0-I:25%,0-IIa:38.5%) or with histologically confirmed ulcer (33.3%). The above mentioned lesions had a relatively lower diagnostic accurancy. The overall undergradeing rate was 3.4%. Conclusions: EUS has a quite high diagnostic accuracy in evaluating the depth of early gastric cancer invasion which helps the planning of treatment strategy. The location, macroscopic type and coexisting ulcer of lesion will affect the dignostic accurancy. The comparation of the depths of tumor invasion assessed by endoscopic ultrasonography (EUS) with the pathologic results for early gastric cancer EUS agree with pathologic resluts for M lesions Overgrading of EUS for M lesions EUS agree with pathologic resluts for SM lesions Undergrading of EUS for SM lesions Overgrading of EUS for SM lesions EUS agree with pathologic resluts for all lesions Overall overgrading lesions Overall undergrading lesions EUS results Pathologic results Number of cases Percentage(%) M M SM(NZ9),MP(NZ1) M SM SM M SM MP SM 0 0 M: mucosal layer; SM: submucosal layer; MP: muscular propria Mo1487 Endoscopic Grade of Peritumoral Atrophy Is Associated With Low Accuracy of Endoscopic Ultrasound in the Staging of Early Gastric Cancer Yong Hwan Kwon, Hyunsoo Chung*, Seok Min Hong, Da Hyun Jung, Jun Chul Park, Sung Kwan Shin, Sang Kil Lee, Yong Chan Lee Gastroenterology, Severance Hospital, Yonsei University, Seoul, Korea (the Republic of) Background: Little is known regarding the relationship between diagnostic accuracy of endoscopic ultrasound (EUS) and peritumoral atrophy and intestinal metaplasia (IM). We aimed to evaluate the contribution of peritumoral atrophy and IM to EUS accuracy. Methods: A total of 349 patients with early gastric cancer (EGC) who underwent surgical resection (69.9%, 244/349) or endoscopic resection (30.1%, 105/349) with curative intent at Severance Hospital, Yonsei University, Seoul, Korea from January to December, 2013 were included. Preoperative EUS staging was compared with the postoperative histopathological outcomes. Peritumoral atrophy and IM were assessed endoscopically by a single experienced endoscopist blinded to the pathologic results. Diagnostic accuracy and clinicopathologic factors affecting the diagnostic accuracy of EUS were also investigated. Results: The overall accuracy of EUS was 62.8% (219/349) for T staging, 81.6% (146/179) for T1a, and 51.8% (73/141) for T1b. Overdiagnosis and underdiagnosis were 27.8% (97/349) and 9.5% (33/349), respectively. Peritumoral atrophy and IM were observed in 50.7% (177/349) and 46.4% (162/349). In univariate analysis, the accuracy rate was negatively associated with endoscopic grade of peritumoral atrophy and IM (p!0.001 and p!0.05, respectively). In addition, presence of ulcer and tumor size were also negatively associated with (p!0.05 and p!0.001, respectively). In multivariate analysis, presence of ulcer, tumor size and endoscopic grade of peritumoral atrophy remained significant (p!0.05, p!0.001 and p!0.05). Conclusions: In this study, the diagnostic accuracy of EUS for T1b EGC was significantly lower than of T1a EGC. Along with tumor size and presence of ulcer, endoscopic grade of atrophy was associated with low accuracy of EUS. When T1b cancer was suspected on EUS, these factors should beaddressedinthe treatment planning. Mo1488 Histological Diagnosis of Gastric Submucosal Tumors: Endoscopic Ultrasonography-Guided Fine-Needle Aspiration Biopsy vs. Mucosal Cutting Biops Hisatomo Ikehara*, Jiro Watari, Masato Taki, Tomohiro Ogawa, Takahisa Yamasaki, Fumihiko Toyoshima, Tomoaki Kono, Katsuyuki Tozawa, Yoshio Ohda, Toshihiko Tomita, Tadayuki Oshima, Hirokazu Fukui, Hiroto Miwa Hyogo college of medicine, Nishinomiya, Japan Background: As gastric submucosal tumors (SMTs) comprise both benign and malignant lesions, histological diagnosis is needed. Endoscopic ultrasonography-guided fine-needle aspiration biopsy (EUS-FNAB) is a useful method for the histological evaluation of SMTs, but only a limited number of patients undergo EUS- FNAB even in hospitals specializing in gastroenterology; an on-site cytologist is also required to improve the diagnostic capability. Aim: The aim of this study is to compare the diagnostic yield, the feasibility, and the safety between EUS-FNAB and mucosal cutting biopsy (MCB) based on endoscopic submucosal dissection. Patients and Methods: The cases of 19 consecutive patients with gastric SMT who underwent both EUS-FNAB and MCB were investigated. We prospectively compared the histological diagnostic yield and complications between the two methods. Results: The final diagnoses were gastrointestinal stromal tumors (GIST, nz7), leiomyoma (nz5), schwannoma (nz2), aberrant pancreas (nz2), glomus tumor, metastatic hepatocellular carcinoma, and nondiagnostic (nz1 each). The tumors mean size was 24.3 mm. Histological diagnosis was made in 68.4% of the EUS-FNAB and 57.9% of the MCB specimens (nonsignificant). There were no significant differences of diagnostic yield based on tumor location or tumor size between the two methods. However, diagnostic specimens were significantlymorefrequentlyobtained in the lesions with intraluminal growth than in those with extraluminal growth by MCB method (pz0.02). All four SMTs with extraluminal growth were diagnosed only by EUS-FNAB, not by MCB (pz0.03). No complications were found with either method. Conclusions: MCB may be chosen as an alternative diagnostic modality in tumors showing the intraluminal growth pattern regardless of tumor size, whereas EUS-FNAB should be performed for SMTs with extraluminal growth. Mo1489 Single Incision Needle Knife (SINK) Biopsy. a More Successful Approach to the Diagnosis of Submucosal Tumors Jason Hwang 2, Andrea Grin 1, Abdulaziz Almasoud 2, Javier Aranda-Hernández 2, Apostolos Tsolakis 2, Tareq Alomani 2, Norman E. Marcon 2, Paul P. Kortan* 2, Gabor Kandel 2, Gary R. May 2 1 Department of Pathology, St Michael s Hospital, Toronto, ON, Canada; 2 Department of Therapeutic Endoscopy, St. Michael s Hospital, Toronto, ON, Canada Introduction: Submucosal tumours (SMTs) in the gastrointestinal tract can be challenging to diagnose accurately using standard imaging and tissue sampling techniques. Current methods of endoscopic tissue acquisition may include the use of endoscopic tunnelled forcep biopsy or endoscopic ultrasonography (EUS) guided fine needle aspiration (FNA) or fine needle biopsy (FNB). SINK biopsy is an alternative EUS assisted approach of tissue acquisition which employs the use of needle knife incision of the mucosa overlying the SMT, followed by deep tissue biopsy with standard endoscopic biopsy forceps. Methods: We retrospectively reviewed the results and outcomes of single incision needle knife (SINK) biopsy performed by a single expert endoscopist at our tertiary referral centre. 21 SMTs biopsied using the SINK technique were identified; 5 esophagus/gastroesophageal junction, 14 stomach, and 2 duodenum. The clinical database was reviewed for lesion characteristics, suspected diagnosis, previous biopsy, immediate and delayed complications and AB438 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
44 surgical resection, if applicable. H&E and immunohistochemistry slides were reviewed by an expert pathologist. Results: EUS wall layer of biopsied SMTs were 2 nd layer (4), 2 nd to 3 rd layer (2), 3 rd layer (1) and 4 th layer (14). All SMTs had an intraluminal protrusion. Needle knife incision, submucosal forceps biopsy followed by endoclip closure of the defect was performed in all cases with an average of 2.1 clips (range 1 to 6). Immediate bleeding with hemostasis not amenable to clipping alone occurred in 3 (14%). All 3 were successfully controlled by endoscopic means (2 epinephrine injection, 1 coagulation forceps) and no other interventions were required. There were no delayed post-procedural complications. Sufficient sampling for a pathological diagnosis was obtained in 17 cases (81%). Biopsy results were leiomyoma (6), gastrointestinal stromal tumor (4), pancreatic rest (3), glomus tumor (1), schwannoma (1), inflammatory fibroid (1), lipoma (1) and inconclusive (4). 12 lesions had prior non-diagnostic EUS-FNA or tunnelled forcep biopsy, of these a specific diagnosis was made in 9 (75%). The final diagnosis changed the pre-pathological clinical impression in 6 of the 17 cases (35%). Conclusions: EUS-assisted SINK biopsy is an effective alternative to conventional endoscopic tissue sampling methods which provides adequate tissue for immunohistochemistry and a specific diagnosis in most cases. For SMT the success appears to be greater than EUS-FNA or tunnelled biopsy where SINK biopsy provided a diagnosis in 75% of cases where previous samples were non-diagnostic. Minor procedural bleeding requiring additional endoscopic therapy is seen in 14% of cases but no serious complications were seen. SINK biopsy should be considered as an alternative to EUS-FNA for pathologic diagnosis of SMT of the gastrointestinal tract. Mo1490 Prospective Evaluation of MRI and EUS for Primary Rectal Cancer Staging: the Sum Is Greater Than the Individual Parts Ferga C. Gleeson*, Michael J. Levy, Joel G. Fletcher, Sawra Maurer, Sheila Buehler, Barham K. Abu Dayyeh, Jonathan E. Clain, Prasad G. Iyer, Elizabeth Rajan, Mark Topazian, Lisa A. Boardman Charlton 8, Mayo Clinic Foundation, Rochester, MN Background: Pre-surgical imaging is key for selecting stage appropriate therapy for rectal cancer patients. A recent overview (2014) of international guidelines failed to reach a consensus on staging guidelines. Aims: To prospectively evaluate MRI and EUS staging concordance and performance characteristics. Methods: Over a 24 month period, 42 patients with primary rectal adenocarcinoma were enrolled, 39 of whom [ years,male(nZ24; 61.5%), CEA (median (IQR): 2 ( )] completed MRI and subsequent EUS FNA staging, by an endosonographer whowasblindedtothemrifindings. Results: The Kappa statistic for T and N staging by MRI and EUS was (95% CI ) and (95% CI ), respectively. Patients with MRI and EUS TNM staging indicating a need for neoadjuvant therapy (R T3 and/or R N1) were identified in 30 (76.9%) and 26 (66.7%), respectively, reflecting a clinically relevant discordance rate of 10%. EUS upstaged MRI T and N findings in 3 (7.7%) and 6 (15.4%) and downstaged MRI T and N findings in 8 (20.5%) and 5 (12.8%) patients. The Kappa statistic and agreement for T and N staging by MRI or EUS to gold standard surgical pathology in the absence of neoadjuvant therapy is highlighted in Table 1. Only 18% of patients had identical MRI, EUS and surgical pathology TNM staging. For T Stage (R T3), MRI and EUS had similar sensitivity (80% each) and EUS had greater specificity (100% vs. 83%; PZ0.0001). For T Stage (% T2), EUS had greater sensitivity (100% vs. 75%; pz0.0001) with similar specificity to MRI (80% each). For N Stage, MRI had greater sensitivity (50% vs. 25%; pz0.0004) but EUS was more specific (100% vs. 80%; pz0.0001). Conclusions: Rectal EUS has superior sensitivity (% T2) and specificity (R T3) when compared to pelvic MRI. However, both imaging modalities had only fair kappa values when evaluating malignant nodal status. MRI and EUS are complementary rather than competitive to each other. A combined staging algorithm with enhanced features to include lymph node contrast enhancement patterns and elastography may enhance nodal staging accuracy. Table 1 MRI - T EUS - T MRI - N EUS - N Kappa % CI % CI Agreement Good Very good Fair Fair Mo1491 Endoscopic Ultrasound and Fine-Needle Aspiration Is a Safe and Useful Technique to Investigate Colorectal Subepithelial Lesion Lídia M. Roque Ramos*, Pedro Pinto-Marques, Tânia Meira, João Freitas Gastroenterology, Hospital Garcia de Orta, Lisboa, Portugal Background: Subepithelial lesions (SEL) are frequent incidental findings of gastroscopy and colonoscopy. 15% are malignant at the time of diagnosis, most patients are older than 50 years-old and there is no gender predominance. Endoscopic ultrasound (EUS) is considered the first line technique to evaluate SEL since it allows: the distinction between extramural compressions and intramural lesions; the definition of layer of origin, dimensions and limits of the lesion; the evaluation of regional lymph nodes; and sampling of SEL for cyto-histological analysis. Unlike the upper gastrointestinal tract studies focusing on EUS and colorectal SEL are scarce. Aim: Determine the safety and adequate tissue sampling of EUS and fine-needle aspiration (FNA) of colorectal SEL. Methods: Retrospective study (January 2008 to September 2014) of all EUSFNA performed for colorectal SEL in two hospitals. Collected clinical data, EUS findings, complications and cytohistological result of FNA. A single experienced operator (mean 580 EUS/year) performed all exams. Results: 3913 EUS wereperformedinthe81monthstudy period in both institutions of which 35 (0,9%) were for colorectal SEL in diferent patients: mean age 6015 years; 51% female; 27 (77%) were located in the rectum and 8 in the sigmoid colon. Table 1 depicts the technical features of EUS. Of the 30 SEL of unknown etiology, 21 were intramural and 9 were extramural compressions. In the extramural group: 7 SEL were non-pathological/benign, specifically, prostate (nz2), vagina/uterus (nz2), internal iliac artery (nz1); a calcified granuloma (nz1) and uterine myoma (nz1); and 2 were suspicious for malignancy. FNA confirmed the diagnosis of urinary gallbladder carcinoma in one patient while the second case, proposed for FNA, was lost in follow-up. In the intramural group the ultrasonography features were consistent with a benign cause in 6 patients: lipoma (nz3), cyst (nz1), hemangioma (nz1) and endometriosis (nz1), the latter confirmed after laparoscopic surgery. In 15 patients a FNA was considered necessary to further assess the lesion. In 13 patients FNA was immediately performed, since a linear instrument was being used, and an adequate sample was obtained in all cases: GIST (nz3); leiomyoma (nz2); lipoma (nz2); endometriosis (nz2); hematoma (nz1); cyst (nz1) and colon adenocarcinoma recurrence (nz1). The remaining 2 patients, both with SEL suspicious for GIST, were lost in follow-up. Only one patient experienced local pain after FNA that subsided spontaneously. There were no complications in the remaining cases. Conclusions: EUS is useful to discriminate extramural from intramural lesions and select patients that should undergo FNA. FNA was a safe procedure and allowed an adequate tissue sampling and definitive diagnosis in all cases. EUS Characteristics Indication n (%) Differential diagnosis SLE 30 (86) Assess depth of neuroendocrine tumor (NET) 5 (14) Echoendoscope n (%) Linear 26 (74) Radial 8 (23) Linear & radial 1 (3) Sedation & Analgesia n (%) Not performed 24 (69) Midazolam & fentanyl (Gastroenterologist) 7 (20) Propofol (Anesthesiologists) 4 (11) Antibiotic prophylaxis 5 (14) FNA (needles) n 25 G 2 22G / C 6 / 2 19G/C/T 2/1/1 Mo1492 EUS-Guided Biopsy for Differentiation of Benign and Malignant Pelvic Lesions: a Systematic Review and Meta-Analysis Zhen Ding* Union hospital, Wuhan, China Background: Preoperative diagnosis of pelvic lesions remains challenging despite advances in imaging technologies. EUS-guided biopsy is an effective and welltolerated diagnostic modality for sampling the digestive tract and surrounding areas. However, a meta-analysis summarizing the diagnostic efficacy of EUS-guided biopsy for pelvic lesions has not been published. Objective: This systematic review and meta-analysis was conducted to evaluate the utility of EUS-guided biopsy in the diagnosis of pelvic lesions. Methods: Data extracted from EUS-guided biopsy studies were selected with strict criteria; only studies where pelvic lesions were confirmed by surgery or clinical follow-up were included. Comprehensive articles were identified via structured database search. A fixed-effect model was used to estimate the sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR). A summary receiver operating characteristic curve (SROC) was also constructed. Results: Ten studies containing a total of 246 patients (between 2000 and 2014) were included in our meta-analysis. The pooled sensitivity of EUS-guided biopsy for differential diagnosis of pelvic masses was 0.89 (95 %CI, ), and the specificity was 0.93 (95 % CI, ). The area under the curve in the summary receiver operating characteristic (SROC) was The combined PLR, NLR and DOR were (95 % CI, Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB439
45 23.43), 0.12 (95 % CI, ), (95% CI, ) respectively. The total complication rate across the ten included studies was 1.69%. Conclusion: Our meta-analysis shows that EUS-guided biopsy is a powerful tool for differentiating pelvic masses with a high sensitivity and specificity. Furthermore, it is a safe procedure with a low rate of complication, although more high-quality prospective studies are required to further validate safety. Mo1493 EUS-Guided Intratumoral Injection of CHST15 Dsrna for Unresectable Pancreatic Cancer: an Investigator-Initiated Trial Makoto Nishimura* 1, Naohisa Yahagi 2 1 Department of Gastrointestinal Endoscopy, Tokyo Metropolitan Geriatric Hospital, Itabashi-ku, Japan; 2 Cancer Center, Keio University School of Medicine, Shinjuku-ku, Japan Background: The glycosaminoglycan chondroitin sulfate E (CS-E) is known to promote tumor invasion by cleaving CD44 on pancreatic cancer cells. Interference with CS-E has been shown to inhibit tumor invasion and metastasis in nonclinical studies. CS-E is upregulated in pancreatic cancer tissue and its biosynthesis is mediated by specific enzyme carbohydrate sulfotransferase 15 (CHST15).CHST15mRNAisreportedtobeupregulatedandtocorrelatewith poor prognosis in several types of cancer. We have shown that synthesized CHST15 dsrna can inhibit the expression of CHST15 glycogene and reduce the secretion of soluble CD44 variant both in dose-dependent manners in human pancreatic cancer cells in vitro. In this study, we conducted an investigator initiated trial of CHST15 dsrna through EUS-guided intratumoral injection in patients with unresectable pancreatic cancer. Objective: To assess safety, feasibility, and tolerability in unresectable pancreatic cancer patients treated by EUS-guided intratumoral injection of CHST15 dsrna. Setting: Tokyo Metropolitan Geriatric Hospital Patients: Patients with stage IV pancreatic cancer were enrolled. Main outcome measures: Primary outcome measures were safety, feasibility, and tolerability. Secondary outcome measures were response in tumor size, overall survival (OS) and disease-free survival. Histopathologically, tumor specimens were also evaluated with CHST15 immuno-stain before and 1 month after injection. Results: A total of four stage IV pancreatic cancer patients with a median age of 76.5 years (male: femalez 2:2) were enrolled. Three of them had undergone standard chemotherapy including gemcitabine or S-1 regimen, and the other patient refused chemotherapy. For all patients, a total of 16 ml (250nM) of dsrna was successfully injected into the tumor under EUS guidance using a 22 gauge needle without related adverse events. Mean tumor size changed from 32.2 mm to 30 mm in diameter one month after the first injection. Histopathologically, all patients (100%) were CHST15 positive in the primary specimen, and reduced CHST15 staining one month after the first injection was detectable, suggesting the effectiveness of dsrna injection. One patient s specimen showed partial necrosis of the tumor. Limitations: This was a single-center clinical trial. Conclusions: This was the first-in-patient trial of EUS-guided injection of dsrna against glycogene in unresectable pancreatic cancer in the world. A single dose administration of CHST15 dsrna showed no drug-related adverse effects at the tested concentration. High safety and feasibility were demonstrated, which will contribute to further clinical trials investigating this anti-tumor agent. Mo1494 EUS-Guided Radiofrequency Ablation (EUS-RFA) Using a Novel Internally Cooled Needle Electrode for Pancreatic Insulinoma: a Case Series in Humans Sundeep Lakhtakia* 2, Mohan Ramchandani 2, Rajesh Gupta 2, Sushma Venugopal 3, Domenico Galasso 1, Nageshwar D. Reddy 2 1 Digestive Endoscopy, Università Cattolica del Sacro Cuore, Rome, Italy; 2 Gastroenterology and Therapeutic Endoscopy Department, Asian Institute of Gastroenterology, Hyderabad, India; 3 Gastroenterology Department, Maimonides Medical Center, Brooklyn, NY Background: Insulinomas are one of the most common functional pancreatic neuroendocrine tumors (PNETs). Although usually small in size, difficult to localize during surgery and with important postoperative morbidities, surgical removal is still the standard of care. A non-surgical treatment for symptoms relief is needed in patients unfit for surgical resection, or unwilling. Endoscopic ultrasound (EUS) has already been used for localization, fine needle aspiration, tattooing and alcohol ablation of insulinoma and other PNETs. Intraoperative radiofrequency ablation (RFA) has been reported for insulinoma. An EUS-guided RFA (EUS-RFA) of insulinoma, when possible, may be beneficial for symptoms relief. There are no reports of EUS- RFA of insulinoma. We present a case series of 3 patients who underwent EUS- RFA using a novel internally cooled needle electrode. Objective: To evaluate feasibility, safety and efficacy of EUS-RFA to manage patients with symptomatic insulinoma. Setting: Tertiary care academic center.patients: Patients presenting at our institution with symptomatic insulinoma, unfit or unwilling for surgery. Interventions: EUS-RFA of pancreatic insulinoma using a novel 19G internally cooled needle electrode.main outcome measurements: Technical success in targeting and ablating the insulinoma; adverse events; symptoms and biochemical levels improvement up to 6 months after EUS RFA. Results: Three male patients (mean age 45 years) with a single or multiple symptomatic insulinoma (Table 1) underwent EUS-RFA. All had rapid symptoms relief and biochemical markers level reduction to normal range. There were no procedure related adverse events. Patients remained symptom free at last follow-up (Table 2). Limitations: Small number of cases, single tertiary care center. Conclusions: EUS-RFA is feasible, apparently safe and effective for symptoms relief in symptomatic pancreatic insulinoma. Table 1. Patient Characteristics Case 1 Case 2 Case 3 Age/Gender 42 year/male 41 year/male 52 year/male Presentation Hypoglycemia with recurrent episodes of seizures for last 4 years Hypoglycemia with frequent eating and significant weight gain (O20Kg) for 1 year Hypoglycemia with recurrent episodes of syncope for 2 years EUS-based Lesion Characteristics Reason for Refusing Surgery Single hypoechoic SOL at body-tail junction; 14x12 mm; early signs of chronic pancreatitis Risk associated with poor cardiac status SOL: space occupying lesion. Table 2. Laboratory Levels and Outcomes Single hypoechoic SOL at genu; 17x12 mm; vascular Risk associated with obesity Multiple hypoechoic SOLs in head, body and tail; largest SOL 22x19 mm in head targeted for ablation Concern over major surgery Case 1 Case 2 Case 3 Pre EUS RFA Fasting Insulin* 41.1 miu/ml 51.2 miu/ml 36.2 miu/ml C-Peptide** 4.0 ng/ml 5.8 ng/ml 5.5 ng/ml Blood Sugar 43 mg/dl 39 mg/dl 49 mg/dl EUS-RFA Access Trans-gastric Trans-gastric Trans-duodenal Procedural Complications None None None 48 hr Post EUS-RFA Fasting Insulin* 10.7 miu/ml 19.8 miu/ml 25.5 miu/ml C-Peptide** 2.4 ng/ml 3.6 ng/ml 4.0 ng/ml Time Post EUS-RFA 6 months 5 months 5 months Long Term Follow-up Blood Sugar Normal Normal Normal Symptoms None 18 Kg weight lost None *Fasting serum insulin: Normal range miu/ml. **C-Peptide: Normal range ng/ml. Mo1495 EUS-Guided Intratumoral Gemcitabine Injection in Locally Advanced Non-Metastatic Pancreatic Cancer Mehdi Mohamadnejad* 1, Farhad Zamani 2, Mehrnoosh Setareh 2, Sepideh Nikfam 1, Reza Malekzadeh 1 1 Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of); 2 Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences, Tehran, Iran (the Islamic Republic of) Introduction: Pancreatic cancer is the fifth leading cause of cancer death worldwide. Desmoplastic reaction is a prominent pathologic feature of pancreatic cancer. The extensive fibrotic and stromal reaction leads to reduced penetration of chemotherapeutic agents and it is considered a major contributing factor for chemoresistance in pancreatic cancer. We aimed to investigate whether direct delivery of a chemotherapeutic agent into the tumor is safe and improves local control of pancreatic cancer. Methods: Newly diagnosed patients with locally advanced, unresectable and non-metastatic pancreatic cancer were treated with two sessions of EUS-guided fine needle intratumoral injection (FNI) of gemcitabine (40 mg/ml), three months apart. The procedure was performed by single endosonographer (MM). The hematology and blood biochemistry laboratory tests AB440 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
46 were measured one day after gemcitabine injection and the patients were followed up clinically to assess toxicity. Spiral CT scan was performed at baseline and one month after the second intratumoral injection. After the first intratumoral injection, the patients underwent chemotherapy or chemoradiotherapy at the discretion of oncologist. The primary end point was safety. As the secondary end point the survival rates of the patients were compared with the survival of a matched cohort of 33 patients with locally advanced, unresectable non-metastatic pancreatic cancer patients who were diagnosed with EUS-guided FNA by the same endosonographer over the past 2.5 years and were followed up regularly. Results: Twelve patients with pancreatic cancer (median age: 65.5; range: years; 6 males) received intratumoral FNI of gemcitabine. A mean 3.1 of needle passes (range: 2-5) were made to inject mean total volume of 4.2 ml (range: 2-5 ml) at the first session corresponding to a mean 168 mg (range: 80 to 200 mg) of gemcitabine. There was no adverse effect observed with intratumoralgemcitabine therapy. The survival rate at six month was 92% in intartumoral gemcitabine therapy group, as compared with 48% in the control group (P: 0.01). There was no statistically significant difference in one year survival rate between the two groups (42% vs. 21% respectively; P: 0.3). There was a trend for higher median overall survival in the intratumoral gemcitabine group (274 vs. 177 days; P: 0.1 on log rank analysis). None of the patients developed downstaging of the tumor. Conclusions: EUS-guided intratumoral gemcitabine injection is safe in pancreatic cancer. The observed higher rate of 6-month survival with two sessions of intratumoral therapy suggests the short term benefit of this procedure. Further randomized controlled trials are needed to assess the efficacy of repeated intratumoral therapies at 3 months interval. Kaplan-Meier curve for survival in intratumoral gemcitabine group compared to control group Mo1496 Endoscopic Ultrasound Guided (EUS) Fiducial Marker Placement Without Fluoroscopy - Safety and Technical Feasibility Gautamy Chitiki Dhadham* 1, Sarah Hoffe 2, Jason B. Klapman 1 1 Advanced Endoscopy, Moffitt Cancer Center, Tampa, FL; 2 Radiation Oncology, Moffitt Cancer Center, Tampa, FL Background: EUS-guided fiducial marker placement to aid in delivery of imageguided radiation therapy (IGRT) of gastrointestinal malignancies is increasing. Most series describe the procedure being performed with fluoroscopy. The aim of our study is to report the technical feasibility,safety and migration rate of fiducial marker placement in a large cohort of patients with gastrointestinal malignancies who underwent EUS-guided fiducial marker placement prior to simulation for IGRT without fluoroscopy. Methods: A retrospective chart review was performed on all patients referred for EUS-guided fiducial marker placement from 08/1/07-7/ 31/14 at Moffitt Cancer Center. In total, 514 patients were identified and included in the study. Results: 514 patients underwent placement of 1093 gold fiducial markers under EUS-guidance without fluoroscopy during the study period. Patients underwent simulation within 72 hours of fiducial placement where correct placement /migration was identified on the treatment planning CT. 240 patients with Eso/GEJ cancer had 405 fiducials placed. 223 patients had placement of the 1 cm X 0.75 mm fiducial backloaded into a 19 ga EUS needle and secured with bone wax. The remaining cases were placed using the 22 ga with a 1cm X 0.35 mm fiducial marker. 510 fiducials were placed in 188 patients with pancreatic cancer. The majority were placed using either the 22ga (414) or the 19ga needle (93). Technical difficulty (intervening blood vessels) was noted in 16 patients, however fiducials were placed in a narrow window. Minor bleeding, which resolved spontaneously, was noted in 7 patients. Intraprocedural fiducial migration was noted in 2 patients. 54 patients with rectal cancer had 103 fiducials placed. 38 patients had fiducials placed in the muscularis propria both proximal and distal to the lesion, 9 had proximal only, and 7 had distal only. Minor bleeding was noted which resolved spontaneously in 1 patient. Technical difficulty was also noted only in patients had 75 fiducials placed into other GI tract lesions. Technical difficulty was noted in placing fiducials into one liver lesion. 2 fiducials slipped during placement into the gastrohepatic ligament and porta hepatis lymph nodes, and minor bleeding was noted in 1 fiducialplacedinasubcarinallymphnode. Regarding fiducial migration, only 2 (.002%) fiducials in 2 esophageal patients migrated which was noted on initial simulation. Conclusions: In the largest retrospective review to date, EUS-guided fiducial marker placement without fluoroscopy is technically feasible and safe. There were minimal intraprocedure/post procedure complications. Imaging at the time of simulation also revealed the migration rate to be extremely low. These results may allow for more widespread adoption of EUS-guided fiducial marker placement in centers where fluoroscopy is not readily available. Mo1497 Endosonographic Examination of the Thyroid Gland Among Patients With Cancers Abdulah A. Mahayni 1, Ghaleb Chawki* 1, Leon J. Yoder 1,3, Fateh A. Elkhatib 4, Amer A. Alkhatib 2,1 1 Gastroenterology, Cancer Treatment Centers of America, Tulsa, OK; 2 The Cleveland Clinic, Abu Dhabi, United Arab Emirates; 3 Gastroenterology, Oklahoma State University, Tulsa, OK; 4 Endocrinology, Integris Health, Oklahoma city, OK Objectives: There is very limited endosonographic literature regarding the thyroid gland, which is frequently visualized during upper endoscopic ultrasound (EUS). Our objective was to describe the normal endosonographic dimensions of the thyroid gland and the prevalence of benign and malignant thyroid lesions encountered during upper EUS within a cancer center setting. Methods: 100 upper EUS procedures, performed between October 2012 and July 2014, included endosonographic examination of the thyroid gland using a radial ultrasound. Data collected prospectively included patients demography, underlying thyroid conditions, thyroid gland dimensions, the presence or absence of thyroid lesions, interventions performed to characterize thyroid lesions and pathology results when applicable. Results: Most of the thyroid glands were endosonographically visualized when the tip of the scope was at 18 cm from the incisors. The average thyroid gland dimensions were 24.5 x 16.4 mm (range mm x mm) and 95% intervals ( mm x mm). Ten cases showed thyroid lesions. Interestingly, 3 previously undiagnosed thyroid cancers were discovered during EUS (two primary papillary thyroid cancers and one anaplastic thyroid cancer). Transesophageal endosonographically guided fine needle aspiration of a thyroid lesion was feasible when the lesion was detected in the inferior portions of the thyroid gland and the tip of the scope was at 18 cm or more from the incisors. Conclusions: Routine EUS examination may detect unexpected thyroid lesions including malignant ones. The endosonographer should examine the thyroid gland while keeping in mind the limitations of EUS in obtaining a full examination of the entire thyroid gland. Demographic features of the patients enrolled in this study Average for Larger Dimension (mm) Average for Smaller Dimension (mm) p-value for Larger Dimension p-value for Smaller Dimension Criterion Subcriterion Age Younger than or older Gender Male Female BMI below or above Presence of Underlying Thyroid Disease Present Absent Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB441
47 Mo1498 Global Assessment of EUS Performance Skills (GEUSP) - a New Tool and Approach to Objectify and Measure the Learning Curve and Technical Skills of Endosonographists Per Hedenström*, Björn Lindkvist, Riadh Sadik Department of Internal Medicine, Division of Medical Gastroenterology, Gothenburg, Sweden Background: The overall learning curve of endoscopic ultrasound (EUS) is regarded long, but until now it is not very well characterized in the literature. There is also a lack of easy to use tools to assess the practical skills of endosonographists in training. Aim: The aim of this study was to elaborate and validate a new tool for the assessment of endosonographists in training and by this elucidate the learning curve of EUS. Method: The study was conducted at a tertiary university endoscopy center in West Sweden. Patients undergoing EUS for clinical reasons were enrolled and examined first by an endosonographist in training (performer) and secondly by an experienced endosonographist (observer). Likewise both doctors performed EUSguided puncture if this procedure was indicated. The observer assessed and scored 5 different parameters of the performer s EUS-procedure, each on a 5-graded scale. A study specific assessment sheet, GEUSP (table 1), was designed for this purpose. Afterwards the performer scored him- or herself regarding the same 5 parameters including an aspect on confidence in own performance. Previous endoscopy experience including EUS and annual endoscopy volumes of the performer were registered. The correlation of the GEUSP-score between the observer and the performer was calculated as was the correlation between GEUSP-score and previous EUSexperience using non-parametric tests. Results: During May-November 2014 a total of 30 patients were examined and four performers were assessed according to GEUSP. There was a good correlation between the overall mean GEUSP-score of the observer and that of the performer (r Z 0.66, p!0.001). There was also a correlation between the overall mean GEUSP-score and the previous overall EUS experience (r Z 0.9, pz0.06). One endosonographist with no previous experience of EUS-FNA examined the majority of the patients (nz25). Based upon time of enrollment this group of patients was divided into an early (nz12) and a late group (nz13). The observer s mean overall GEUSP-score of the late group was higher than that of the early group (3.3 vs 2.9, pz0.09). Filling out the assessment sheet took few minutes and did not have a negative influence on the everyday endoscopy program. Conclusions: A new tool for the assessment of endosonographists in training (GEUSP) has been proven feasible and simple to use in clinical practice. Further evaluation of a larger cohort of endosonographists and patients during a longer time period is ongoing. GEUSP Score Sheet PARAMETER A Navigation and visualisation B Recognition anatomy C Recognition pathology D Targeting lesions E Overall examination quality F Confidence (performer only) SCORE 5 (no guidance) SCORE 4 SCORE 3 (verbal guidance) SCORE 2 SCORE 1 (practical guidance) Mo1499 A Global Survey of the Procedural Practice of EUS; Policies Pertaining Anticoagulants, Antibiotics and Sedation Practice Priscilla A. Van Riet*, Marco J. Bruno, Jan-Werner Poley, Djuna L. Cahen Department of Gastroenterology and Hepatology, Erasmus University Medical Center Rotterdam, Rotterdam, Netherlands Background: Although endoscopic ultrasound (EUS) guided tissue sampling is widely performed, global practice guidelines are lacking and procedures are based on local expertise and consensus. This survey was performed to gain insight in current routines regarding peri-procedural measures, and to evaluate diversities amongst various continents. Methods: Four hundred endosonographers from the United States (US), Europe, and Asia were approached to complete an online survey, consisting of 18 multiple-choice questions regarding their periprocedural management of anticoagulants, antibiotics, and sedation. Results: Hundred eighty-six surveys were returned (47%); 85 (46%) from Europe, 54 (29%) from the US, and 47 (25%) from Asia. The median age of the respondents was 46 (IQR 41-52) years. Most were male (90%), gastroenterologists (96%), working in an academic setting (79%), and performing O100 EUS-FNA procedures per year (68%). Preprocedural coagulation status was routinely checked by 66% European and 68% Asian respondents, but only by 20% respondents from the US (p!0.001). Eighty percent of all respondents considered an INR!1.5tobesafe.AllUSrespondents continued acetylsalicylic acid, while 87% and 50% of the European and Asian respondents did not (pz0.004, Table 1). Thienopyridines, heparin, coumarins, and new oral anticoagulants (NOACs) were discontinued by the majority of respondents (O73%). Eighty-six percent of European respondents discontinued Coumarins regardless of checking the coagulation status, as compared to 46% and 59% of the participants from the US and Asia (pz0.003). Heparin, on the contrary, was discontinued by 75% of the Europeans, as compared to 100% of the US and 94% of Asian respondents (pz0.022). Virtually all respondents prescribed antibiotic prophylaxis when sampling a cystic lesion (95%). A minority (!39%) used antibiotic prophylaxes for other indications, such as a prosthetic cardiac valve, vascular graft, previous infective endocarditis, or congenital heart disease (Table 2). For these conditions, US physicians prescribed antibiotic prophylaxes significantly less often. Propofol was the preferred sedative in the US (83%), while in Europe and Asia, conscious sedation was favored by 52% and 84%, respectively (p!0.001). Anesthesiological assistance was available for all US respondents (100%), but only for 66% and 50% of respondents from Europe and Asia (p! 0.001). Conclusions: Overall, peri-procedural management for EUS guided tissue sampling in the US differs notably from Europe and Asia. First, US respondents do not routinely check the coagulation status and always continue acetylsalicylic acid. In addition, they reported lower use of antibiotic prophylaxis. Finally, sedation with propofol is more common in the US, as is the presence of anesthesiological assistance. Table 1. Discontinuation of anticoagulants according to continent Variables US n [ 11 Europe n [ 56 Asia n [ 32 All n [ 99 p- value* Anticoagulant - no. stopped (%) Acetylsalicylic acid 0 (0) 7 (13) 16 (50) 23 (23)!0.001 Thienopyridines 8 (73) 47 (84) 25 (78) 80 (81) Heparin 11 (100) 42 (75) 30 (94) 83 (84) Coumarins 5 (46) 48 (86) 19 (59) 72 (73) NOAC s 10 (91) 49 (88) 21 (66) 80 (81) NOAC, new oral anticoagulants. *A chi square test was used to compare the three continents. Table 2. Antibiotic prophylaxes given per indication in the US, as compared to Europe and Asia Variables US n [ 38 Europe + Asia n [ 94 All n [ 132 p-value* Indication - no. given (%) Prosthetic valve 6 (16) 35 (37) 41 (31) Vascular graft 1 (3.0) 16 (17) 17 (13) History of IE 5 (13) 47 (50) 52 (39)!0.001 History of CHD 2 (5.0) 17 (18) 19 (14) Lesion lower GI tract 13 (34) 31 (33) 44 (33) IE, Infective endocarditis; CHD, congenital heart disease; GI, gastrointestinal. *A chi square test was used to compare the two groups. Mo1500 Endoscopic Ultrasound Practice Variations Based on US Medicare Data James J. Farrell* 1, Jennifer M. Woo 2 1 Yale University School of Medicine, New Have, CT; 2 UWM-Zilber School of Public Health, Milwaukee, WI Background: Accurate data about EUS practitioner volume and practice patterns in the United States is lacking. The evolution of integrated healthcare systems and the rapid growth in the demand for EUS training has led to concerns about future oversupply of gastroenterology and endoscopic ultrasound subspecialists. Using the recently released 2012 Medicare payments to physicians from the Centers for Medicare and Medicaid Services (CMS), we aim to study EUS practice patterns in the US in relation to overall gastroenterology and patient population. Methods: EUS procedure and practitioner data from the CMS database for unique Medicare claims (2012) was assessed using the two CPT codes unique to EUS: AB442 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
48 43259 (EUS), and (EUS with FNA) US census data were utilized. The total number of gastroenterologists and EUS practitioners, geographic location and volume relative to state population including Medicare population were analyzed. Data are presented as mean and standard deviation with the highest and lowest states for each parameter given. Limited interpretation of procedure volume was assessed as the data only provides data on Medicare EUS procedures, which would represent a fraction of all EUS procedures. Results: There were 894 EUS practitioners (M:F, 804:90) out of a total number of gastroenterologists who performed Medicare EUS/EUS-FNA procedures in Five states had only 1 EUS practitioner: AK, AR, HI, MT and ND; and 2 states had none: WY and ID. Within each state, there is a concentration of endoscopic ultrasound practitioners around larger cities (Figure 1). Nationally 7.4 +/- 3.6 % of all gastroenterologists (1 in 13) perform EUS, with higher rates (10-16%) in IN, ME, MN, NM,SC,SD,OR,VTandWVandlowerrates(0-5%)inAR,HI,LA,MS,MT,ND,RI, TN, WY(0%) and ID(0%). The mean number of Medicare EUS/EUS-FNA procedures per EUS practitioner is / (21%) EUS practitioners performed only EUS, with 69 (8%) EUS practitioners performing EUS with FNA only. Of the remaining 633 EUS practitioners performing both Medicare EUS (54.4+/- 15.2%) and EUS-FNA (45.6+/-12.2%), 39, 10, 6, and 2 EUS practitioners performed O200, O300, O400 and O500 Medicare procedures respectively. Nationally the mean EUS practitioner rate is 2.8+/-1.5 per 1,000,000 US population, and 22.1+/-12.2 per 1,000,000 population over 65 yrs., with high rates seen in: CT, MA, VT; and low rates seen in: AK, AR, HI, MS and MT (Figure 2). Conclusions: There is wide state-to-state variation in both the rate of EUS practitioners per gastroenterologist and per population including Medicare population. 21% of EUS practitioners do not perform EUS-FNA biopsy. Additional projected overall EUS procedure volume, physician demographic analysis and long-term population projections will allow recommendations about future manpower and training needs. Mo1501 Development of an Endosonography App: a Smart Device for Continuous Education Ji Young Bang* 1, Robert Hawes 1, Paul Fockens 2, Shyam Varadarajulu 1 1 Center for Interventional Endoscopy, Florida Hospital, Orlando, FL; 2 Gastroenterology-Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands Background: EUS has become an integral part of endoscopic practice. However, it is a difficult technique to learn and access to training and education is limited, particularly in developing countries. Smart devices have become ubiquitous and represent an opportunity to make endoscopic training material available to use at any time. Objective: To assess the utilization of a smart device compatible App dedicated to EUS training. Methods: The EUS App, released in 2012, is a free download compatible with both ios (iphone/ipad) and Android devices. The App is 636MB in size and is developed in English language. The educational contents are categorized into six sections: videos on diagnostic techniques and interventions, video atlas of cases, primer on cytopathology, literature update (quarterly newsletter) and educational resources (TNM staging, procedural protocols, guidelines and lecture slides). Outcome measures: To determine the utilization, frequency and pattern of usage of the EUS App using the FLURRY diagnostic system. Results: The EUS App has a total of 11,501 registered users (iosz9,341; ios, AndroidZ2,160). More than 95% of registrants were related to Health or Health-related industry, O75% age!55 years and 55% male. The App was accessed by users in 107 countries representing all continents. Geographic profile revealed that 49.9% users were from North America/Europe and 50.1% from other regions of the World (Asia 20.5%, South America 11.2%, Middle East 9.8%, Africa 4.2% and rest of the World 4.4%). The mean number of users accessing the App/day was 404, for 3-10 minutes (range), with O60% viewing 1-2 sessions/week (figure). An analysis of the sessions viewed suggests that the majority (59.0%) of users access the App to learn EUS (diagnostics 40.8% and interventions 18.2%) followed by literature update 20.6%, educational resources 11.1%, video atlas 8.5% and others 0.8%. The maximum usage coincided with the release of new Updates (literature update and new videos) at a mean of 6,987 sessions/release date. The average user rating for the App (nz51 Android; nz 47 ios) in the public domain was 4.9 of 5. Conclusions: The smart device appears to be an effective tool for disseminating EUS educational materials. The users primary interests are learning EUS and knowing the latest literature. Future endeavors to maximize its effectiveness will include measuring the impact of the App on learning EUS, incorporating resources for patients, and translation of the App into multiple languages. Fig. 1. Geographic Distribution of EUS Practitioners based on postal codes. No. of sessions accessed by App users Fig 2. EUS Practitioner rate per 1,000,000 overall population. Individual States. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB443
49 Mo1502 The Value of Endoscopic Full-Thickness Resection for Gastric and Duodenal Submucosal Tumors Originating From the Muscularis Propria Layer Chen Zhang, Quan-Lin Li, Mei-Dong Xu*, Li-Qing Yao, Ping-Hong Zhou Endoscopy Center, Zhongshan Hospital, Fudan University, Shanghai, China Objective: To assess the value of endoscopic full-thickness resection (EFTR) technique for gastric and duodenal submucosal tumors (SMTs) originating from the muscular propria (MP) layer. Methods: A total of 276 patients with solitary gastric SMT originating from the MP layer underwent EFTR between January, 2010 and February, The tight adhesion of the tumor to gastric or duodenal serosal layer was revealed in all cases on endoscopic ultrasound before the procedure. EFTR was performed using a standard ESD technique without laparascopic assistance under direct endoscopic view. The defect of gastric and duodenal wall was closed after resection. Results: There were 94 males and 182 females. The median age was 57.8 years (range, years). Among all the 276 lesions, 165 located in the gastric fundus, 96 located in the gastric body, 8 located in the gastric antrum, 1 located in the angle of stomach, and 6 located in the duodenum. The median lesion size was 1.7 cm (range cm). The success rate of EFTR was 98.9% (273/276). EFTR was failed in 3 cases: one case was out of control because of bleeding into enterocoelia, two cases required conversion into laparoscopic surgery because of giant lobulations of the tumor outside the cavity. The median operation time was 65 min (range, min). En bloc resection rate was 98.1% (268/273), while piecemeal resection rate was 1.9% (5/273). The median length of hospital stays was 4.4 days (range, 1-23 days). Pathological outcomes revealed 137 (49.7%) gastrointestinal stromal tumors (GISTs), 103 (37.3%) leiomyomas, 13 (4.7%) schwannomas, 8 (2.9%) calcifying fibrous tumors, 7 (2.5%) glomus tumors, 5 (1.8%) ectopic pancreas, and 3 (1.1%) fibroblastomas. The procedure-related complications were as follows. Pneumoperitoneum occurred in all the patients and were treated successfully with peritoneocentesis decompression. Different degrees of epigastric pain occurred in 168 (60.9%) cases, and 24 (8.7%) of them required analgesics. Seroperitoneum occurred in 15 (5.4%) cases. Localized peritonitis occurred in 3 (1.1%) cases, and digestive tract leakage occurred in 1 (0.4%) case. All the cases with above complications recovered spontaneously or after conservative treatments. No massive bleeding or adominal abscess was found after EFTR. None of the 273 cases developed procedure-related death. No tumor residual or recurrence was found during the follow-up period ranging 3-55 months. Conclusions: EFTR without laparoscopic assistance is minimally invasive, safe, and effective for treating gastric and duodenal SMTs originating from the MP layer and adhering tightly to the serosa. High en bloc resection rate could be achieved. However, a larger number of the cases and long-term outcome deserve further research. (EUS-BD) techniques potentially offer multiple advantages in these patients. It is currently unknown how e-ercp and EUS-BD compare in such patients. Aims: 1) to compare efficacy and 2) safety of both techniques and 3) study predictors of these outcomes. Methods: This was an international multicenter comparative cohort study at 10 tertiary centers (3 US, 3 European, 3 Asian and 1 South American; 2 centers with published expertise on e-ercp and 8 centers on EUS-BD) between 2008 and All patient with altered UGI anatomy who presented with benign or malignant biliary obstruction and subsequently underwent e-ercp (2 centers) or EUS-BD (8 remaining centers) were included. Outcomes data included technical success (biliary access with cholangiography and stent placement (when indicated), clinical success (resolution of biliary obstruction) and adverse events (graded according to the ASGE lexicon). Results: A total of 98 patients (mean age 58yr, female 67%, malignant biliary obstruction 36%) underwent EUS-BD [nz49; Hepatogastrostomy (HG) 33 (67.4%), antegrade stenting (AG) 10 (20.5%), rendezvous 2 (4%), Hepatojejunostomy 3 (6.1%), Hepatoduodenostomy 1 (2%)] or e-ercp [nz49; single balloon enteroscopy (SBE)-ERCP 5 (10.2%), double balloon enteroscopy (DBE)-ERCP 42 (85.7%), or colonoscope-ercp 2 (4.1%)]. There was higher frequency of malignant obstruction in the EUS-BD group (p!0.0001), but higher frequency of Roux-en-Y (RY) anatomy (p!0.0001) and native ampulla (p!0.0001) in the e-ercp group. Technical success was achieved in 48 (98%) patients in the EUS-BD group as compared to 32 (65.3%) patients in the e-ercp group (OR 12.48, pz0.001). Clinical success (intention-to-treat) was attained in 88% of patients in EUS-BD group as compared to 60.4% in the e-ercp group (OR 2.83, 95% CI , pz0.03). Procedural time was significantly shorter in the EUS-BD group (55min vs 95min, p!0.0001). Adverse events occurred more commonly in EUS-BD group (20% vs. 4%, pz0.01). However, majority (90%) of complications were mild/moderate. Length of stay was significantly longer in the EUS-BD group (6.6d vs. 2.4d, pz!0.0001). On multivariate analysis, EUS-BD was independently associated with increased rate of clinical success (OR 4.31, 95% CI , pz0.02) and adverse events (OR 8.74, 95% CI , pz0.01) (table 1). Conclusions: EUS-BD offers multiple advantages over e-ercp in patients with surgical UGI anatomy, including higher technical success, higher clinical success, and reduced procedural times. However, EUS-BD is also associated with increased rate of adverse events, although severe events are uncommon. Table 1. Univariate and multivariate analysis of variables associated with clinical success and adverse events Unadjusted Adjusted OR 95% CI P-value OR 95% CI P-value Clinical Success EUS-BD vs e-ercp RY anatomy Native ampulla Adverse Events EUS-BD vs e-ercp RY anatomy Native ampulla Mo1503 International Multicenter Comparative Trial of EUS-Guided Biliary Drainage vs. Enteroscopy-Assisted ERCP in Patients With Surgical Anatomy and Biliary Obstruction Mouen Khashab* 1, Mohamad H. El Zein 1, Kaveh Sharzehi 2, Fernando P. Marson 3, Oleh Haluszka 2, Aaron J. Small 4, Yousuke Nakai 5, Do Hyun Park 6, Rastislav Kunda 7, Anthony Y. Teoh 8, Irene Peñas 9, Manuel Perez-Miranda 9, Vivek Kumbhari 1, Ahmed A. Messallam 1, Schalk Van Der Merwe 10, Everson L. Artifon 3, Andrew S. Ross 4 1 Johns Hopkins Medical Institute, Baltimore, MD; 2 Temple University, Philadelphia, PA; 3 Ana Costa Hospital, Sao Paulo, Brazil; 4 Virginia Mason, Seattle, WA; 5 The University of Tokyo, Tokyo, Japan; 6 University of Ulsan College of Medicine, Ulsan, Korea (the Republic of); 7 Aarhus University, Aarhus, Denmark; 8 The Chinese University of Hong Kong, Hong Kong, China; 9 Hospital Universitario Rio Hortega, Valladolid, Spain; 10 University Hospital KU Leuven, Leuven, Belgium Background: ERCP is challenging in patients with surgically altered upper gastrointestinal (UGI) anatomy with reported cannulation rates of enteroscopy-assisted ERCP (e-ercp) between 48 and 70 %. Endoscopic ultrasound-guided biliary drainage Mo1504 Mobile Health (M-Health): a Novel Therapeutic Endoscopic Capsule for Treating Gastrointestinal Bleeding Carmen C. Poon*, Billy H. Leung, Ruikai Zhang, Cecilia K. Chan The Chinese University of Hong Kong, Hong Kong, Hong Kong Background: Commercial wireless capsule endoscope (CE) is a single-function device for viewing the inner gastrointestinal (GI) tracts. Although wireless CE provides a painless and ambulatory method for diagnosing diseases such as GI bleeding, once diagnosed, the patient must be treated inside the hospital by doctors using conventional endoscopy. Aim: This study presents initial study of a novel therapeutic capsule for treating GI bleeding in an ambulatory setting. Method: The proposed system consists of a therapeutic capsule integrated with a balloon that is to be inflated by gas generated from a chemical reaction inside the CE. As shown in Fig. 1, the chemical reaction is designed to be triggered wirelessly by an external device such as a smartphone in order to inflate and anchor the CE at the bleeding site. Force generated by the inflatable balloon is designed to stop GI bleeding by tamponade effect. An ex-vivo porcine colon experiment was conducted for proof-ofconcept. The CE was triggered wirelessly in the porcine colon model. To test how well the CE could be anchored at a position in the GI tract, a force gauge was used to measure the maximum longitudinal dragging force that a CE could withstand. Air pressure in the balloon was measured to test if the CE can provide sufficient force to create a tamponade effect. Results: The proposed system was tested for 7 trials at 7 different positions in 3 ex vivo porcine colon models of diameter ranges from mm. The CE withstood maximum longitudinal dragging force ranged from N, which is larger than 0.91 N, the estimated longitudinal force that a conventional wireless CE will encounter in a colon [1]. Once inflated, the balloon on the CE can maintain an averaged air pressure of mmhg, which is above the reported air pressure of 70 mmhg for controlling bleeding by balloon tamponade [2]. In all the trials, the inflated CE was found to be able to anchor the colon steady even when the AB444 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
50 porcine colon model was hung vertically. Conclusions: The ex-vivo experiments showed that the proposed system is a potential solution for painless and ambulatory GI bleeding treatment. In the future, GI bleeding detection algorithms will be integrated into the system for automatic balloon deployment. References: [1] Woods et al. IEEE Transactions on Biomedical Engineering, 60.4 (2013): [2] Panes, J., et al. Digestive diseases and sciences 33.4 (1988): Fig. 1. System Overview of the Therapeutic Capsule. Mo1505 Over-the-Scope-Clip and CAP-Assisted Method for the Resection of Epithelial and Submucosal Lesions of the Gastrointestinal (GI) Tract: a Multi-Center Study Shabnam Sarker* 2, Marcel Sandmann 1,2, Seiichiro Abe 3,2, Martin Faehndrich 1, Ivan Jovanovic 2, Monkemuller Klaus 2 1 Gastroenterology, Klinikum Dortmund, Dortmund, Germany; 2 Basil I. Hirschowitz Endoscopic Center of Excellence, University of Alabama, Birmingham, AL; 3 Division of Endoscopy, National Cancer Center, Tokyo, Japan Background: The over the scope clip device (OTSC) was developed for the closure of gastrointestinal (GI) defects such as perforations, fistulas, anchoring of fully covered self-expanding metal stents and therapy of GI bleeding. This cap-assisted clip-device is released after suctioning tissue into the distal transparent cap. We have previously demonstrated on the feasibility to use the OTSC for the resection of subepithelial tumors of the GI tract. Aim: To evaluate the efficacy and safety of the OTSC for the resection of GI tumors. Methods: Retrospective, observational, open label, multi-center study of patients undergoing endoscopic resection (including endoscopic full-thickness resection, eftr) of GI lesions with the OTSC-system. Once the lesion was characterized endoscopically, the OTSC-system as loaded on the scope and the lesion was suctioned into the transparent cap before releasing the clip. The lesions were then resected above the clip using a hexagonal or duckbill snare. Results: Thirty-one patients (16 male, 15 female, median age 61 years, range 21 to 85, mean ASA 3, range 2-4) were included. The indications for endoscopic resection were: neuroendocrine tumor (NET) of the duodenum nz6, NET of the rectum nz8, NET of the stomach nz4, adenoma of the duodenum, nz1, granular cell tumor of the esophagus n Z 2, colon lesions (scarred, incompletely resected adenomas or carcinoma in situ) (nz7), submucosal tumor of the stomach, nz1, gastrointestinal stromal tumor (GIST) of the stomach, nz1, duodenal GIST, nz1. The mean size of the lesions was 18 mm, range 8 to 25 mm. Fourteen cases were performed with the 12/6 device and seventeen cases were performed with the 14/6 system. A successful tissue resection (technical success) was accomplished in 28/31 (9%). Overall, a complete resection (R0) (oncological success), including eftr was accomplished in 26/31patients (84%). There were no complications associated with device placement or endoscopic resection. Conclusions: In this large study the OTSC system was useful and safe to accomplish endoscopic removal, including fullthickness resection of various types of submucosal and mucosal GI tumors such as NET, granular cell tumors, GIST and early cancers. Comparative studies evaluating this technique with standard EMR and/or ESD are warranted. over an 12-week period and substantial suppression of systemic ghrelin levels. Materials and Methods: The institutional animal care and use committee approved this study. Ten healthy growing swine (mean weight,21.7 kg; weight range,17-30 kg, nz10) were evaluated. Endoscopic Submucosal Dissection was performed by a supervisor who had clinical experience of ESD. The mean size of the resected specimens was 10.8 cm (range, 9 to 12cm) at least involved resection of one thirds of the stomach fundus in experimental swine. Five swine underwent gastric endoscopic submucosal dissection, while five control animals do not underwent. Weight were obtained in animals at baseline and at weeks 1-12 and fasting plasma ghrelin were obtained in animals at baseline and at months 1-2. Endoscopy and gastrointestinal radiography were performed at months 1-2. Statistical testing for differences in serum ghrelin levels and weight at each time point was performed with the mixed effect model of SAS 9.3 analysis (MIXED model) for intragroup differences and intergroup differences. Results: The pattern of change the volume of stomach and change of weight in over time was significantly different between control and experimental animals. The average postprocedure weight in experimental animals was significantly lower than that in control animals (51.6 kg vs kg 11.86, respectively ; P Z ).The pattern of change in ghrelin levels over time was significantly different between control and experimental animals. Monthly ghrelin levels were measured in control and experimental animals as a change from baseline ghrelin values (F Z 90.11, P Z ). In treated animals, ghrelin levels were significantly reduced at month1 (mean, pg/ml [standard error of the mean], P! 0.05), month 2 (mean, pg/ml 17.93, P! 0.05), relative to baseline (mean, pg/ml21.36). Ghrelin values in control animals remained relatively constant over 2 months (mean, pg/ml 60.93). Conclusion: Endoscopic Submucosal Dissection can effectively and durably decrease the volume of stomach and significantly suppress ghrelin, thus significantly affect weight gain. Change in weight over Time Week Experimental Group Control Group F Value P Value Week * Week Week Week Week Week Week Week Week Week Week ! Week *Data are mean standard deviation. Mo1506 Usefulness of the Endoscopic Submucosal Dissection for Lossing Weight and Suppressing Systemic Ghrelin Levels in a Porcine Model Bing-Rong Liu*, Man Wang The Second Affiliated Hospital Of Harbin Medical University, Harbin, China Purpose: To prospectively test in a porcine model the hypothesis that gastric endoscopic submucosal dissection as a new bariatric technique can affect weight gain The resected specimen Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB445
51 Mo1507 A Comparative Randomized Trial of Pre-Emptive Dexamethasone for Relief of Pain After Endoscopic Submucosal Dissection for Early Gastric Neoplasm Jeung Hui Pyo*, Hyuk Lee, Yang Won Min, Byung-Hoon Min, Jun Haeng Lee, Poong-Lyul Rhee, Jae J. Kim Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of) Background and Aims: Although pain is a common complication of endoscopic submucosal dissection (ESD), management strategies are inadequate. Our prior research indicated that single-dose postoperative intravenous dexamethasone after ESD effectively relieved epigastric pain (Surg Endosc Aug;28(8): ). Transmission of pain signals evoked by tissue damage leads to sensitization of the peripheral and central pain pathways. Pre-emptive analgesia is a treatment that is initiated before the surgical procedure in order to reduce this sensitization. In this respect, it was known that preoperative administration of dexamethasone appears to produce a more consistent analgesic effect compared with intraoperative administration. Therefore, we aimed to compare the clinical effect of the pre-emptive and postoperative dexamethasone onpainafteresdforearlygastricneoplasm. Methods: Forty patients with early gastric neoplasm scheduled for ESD were randomized into two groups: group I patients (n Z 20) were given 0.15 mg/kg dexamethasone intravenously before ESD and placebo after ESD, while group II patients (n Z 20) received a matching to pre-esd placebo and post-esd dexamethasone at the same scheme. In this double-blinded, placebo-controlled trial, patients completed a questionnaire about present pain intensity (PPI) and short-form McGill pain (SF-MP) categories for immediate and 6-, 12-, and 24-h postoperative periods. The primary outcome variable was PPI at 6 h following ESD. Secondary outcome variables included pain medication, SF-MP scores, complications, second-look endoscopic findings, and length of stay. Results: The mean 6-h PPI value was significantly lower (p Z 0.037) in the group I ( ) than in the group II ( ). The total 6-h SF-MP score, especially the sensory domain, was higher (p Z 0.031) in the group II ( ) than in the group I ( ). Frequency of additional tramadol injection for epigastric pain relief was not different between two groups (10.0% vs. 15.0%, p Z 0.633). No differences were noted between groups in length of stay or complications, including acute or delayed bleeding. The distribution of artificial ulcer patterns at 48-h post-esd as determined by second-look endoscopy was similar in both groups. Conclusion: Our data suggest that pre-emptive administration of dexamethasone appears to produce a more superior analgesic effect compared with postoperative administration in ESD for early gastric neoplasm. advanced gallbladder interventions were feasible and safe. An array of procedures can be performed such as stone removal, laser lithotripsy, magnifying narrow band imaging, confocal microscopy, EUS and cholecystogram. This opens up exciting possibilities for endoscopic treatment of gallbladder stones and polyps. Mo1508 Adventures in the Gallbladder! Initial Experience of Advanced Gallbladder Interventions After Gallbladder Stenting Shannon M. Chan* 1,2, Anthony Y. Teoh 1,2, James Y. Lau 1,2, Philip W. Chiu 1,2, Enders K. Ng 1,2 1 General Surgery, Prince of Wales Hospital, Hong Kong, Hong Kong; 2 General Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong Background and Aims: Traditionally, endoscopy of the gallbladder is not possible. However, the recent development of endosonographic (EUS) - guided gallbladder drainage with a lumen apposing stent (AXIOS, Xlumena, USA) made endoscopic assessment and advanced gallbladder interventions via the stent possible. The aim of this study was to assess the feasibility and safety of cholecystoscopy and the types of interventions that can be performed in these patients. Methods: This was a retrospective review conducted in the Prince of Wales Hospital from 1 st June, 2012 to 31 st October All patients that suffered from acute cholecystitis with EUS-guided transgastric or transduodenal gallbladder drainage and placement of a lumen apposing stent (AXIOS, Xlumena, USA) were included. Cholecystoscopy was performed in these patients 3 months after insertion to check for clearance of stones and removal of stent. Patients demographic data, the feasibility, complications and types of intervention were recorded. Results: 17 patients had the lumen-apposing stent inserted within the study period. 15 cholecystoscopes were performed, 2 on the same patient and 2 were unsuccessful. 1 was due to obstruction by gallstone, the other was due to angulation. Two of the procedures were performed a few days after insertion of AXIOS stent for clearance of sludge and stones to facilitate drainage. 4 cases had residual gallstones removed. One patient had a 2cm gallstone with laser lithotripsy performed and complete stone removal. Cholecystogram was performed in 6 patients, one of which showed common bile duct stone (CBD). ERCP was performed in the same session and the CBD stone removed. Magnifying endoscopy was performed in 8 patients and confocal microscopy and EUS in one. A highly suspicious polypoid growth was detected in one patient with confocal imaging and biopsy showing adenomatous fragments with high-grade dysplasia. Invasion of the muscularis propria was also suspected on EUS. One patient suffered from cholangitis after the procedure. Conclusion: Cholecystoscopy and Mo1509 The Usefulness of the Clip-and-snare Method With a Pre-Looping Technique During Colorectal Endoscopic Submucosal Dissection Hiroyoshi Nakanishi*, Shinya Yamada, Naohiro Yoshida, Shigetsugu Tsuji, Yasuhito Takeda, Hisashi Doyama Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa-shi, Japan Background and Aims: Colorectal endoscopic submucosal dissection (ESD) is technically challenging. The clip-and-snare method (CSM), a traction method used during gastric ESD, is one of the more promising techniques to achieve ESD more easily and safely (Yasuda M. et al. Gastrointest Endosc 2012;75:AB244). However, this method requires additional forceps to deliver the snare to the clip and is sometimes difficult. We improved this process by using a pre-looping technique (PLT) (Yoshida N. et al. Endoscopy, in press). The aim of this study was to verify the usefulness of the CSM with PLT for colorectal ESD. Methods: We compared 18 colorectal tumors treated using the CSM with PLT during ESD from November 2013 to September 2014 with 18 matched tumors as controls treated without this method from August 2009 to November Matching factors were the location, size, and presence of fibrosis. We evaluated the ESD time, the en bloc resection rate, and the complication rate. The procedure of the CSM with PLT was as follows: After circumferential cutting, the scope was withdrawn once to pre-loop a snare (SD- 221U-25; Olympus Medical Systems, Tokyo, Japan) over the attachment on the tip of the scope. The scope and snare were reinserted up to the tumor. A reusable clip deployment device (EZ Clip; Olympus) and a hemoclip (HX ; Olympus) were inserted through the endoscope channel and used to grasp the mucosal flap of the tumor. The pre-looping snare was then loosened from the attachment, with care taken not to release the hemoclip completely from the device, and then moved along the device toward the hemoclip. We then tightened the snare to grasp the AB446 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
52 hemoclip. We were now able to release the hemoclip from the device, and traction was achieved with the snare and hemoclip independent of the scope, enabling good visualization of the submucosal layer. When the tumor was located from cecum to descending colon, we used a sliding tube (ST-Y0001-4C2; Olympus). Dissection was performed with an electrosurgical knife (ITknife nano; Olympus). All ESDs were performed by two endoscopists (S.Y. and H.D.). This study was approved by the local ethics committee. Results: Clinical outcomes and characteristics between the CSM with PLT group and the control group are shown in Table. The en bloc resection rate was 100% in both groups. The ESD time was significantly shorter in the CSM with PLT group than in the control group (49.2 vs minutes, respectively; PZ0.046). There was no significant difference in the complication rate between the two groups. However, while one perforation occurred in the control group, no perforations occurred in the CSM with PLT group. Conclusion: The CSM with PLT resulted in a shorter ESD time. There was no increase in complications. Even in the proximal colon, we could perform the CSM with PLT using a sliding tube. Table. Clinical outcomes and characteristics between the CSM with PLT group and the control group ESD time (mean) En bloc resection Complication Tumor size (mean) Location Cecum Ascending colon Transverse colon Descending colon Sigmoid colon Rectum Fibrosis Presence Absence CSM with PLT n[ min 100% 5.6% 32.4mm 5.6% 11.1% 16.7% 5.6% 5.6% 55.6% 16.7% 83.3% Control n[18 P value 75.8min 100% 11.1% 31.6mm 5.6% 11.1% 16.7% 5.6% 5.6% 55.6% 16.7% 83.3% CSM, the clip-and-snare method; PLT, pre-looping technique Mo1511 Endoscopic Zenker s Mucomyotomy With the Carr-Locke CAP Simi Singh* 2, David L. Carr-Locke 2, Ross I. Kaye 1, Nathaniel Ernstoff 1, Ricardo Cabello 1 1 Internal Medicine, Beth Israel Medical Center, New York, NY; 2 Gastroenterology, Mount Sinai Beth Israel, New York, NY Introduction: Flexible endoscopic treatment of Zenker s diverticulum is well-established. A number of techniques has been described to achieve the cricopharyngeal myotomy, mostly freehand electrosurgical incision with or without a standard distal endoscope cap. 1 The only purpose-designed accessory is a slotted overtube which is not available in the US. 2 This report describes our experience with a novel cap in performing cricopharyngeal mucomyotomy. Methods: We report a novel technique used in eight patients for the treatment of Zenker s diverticulum. A purpose-designed clear soft plastic distal attachment with one long and one short blade was placed on the end of the endoscope to help separate the esophagus from the Zenker s diverticulum (image 1). The cap allows isolation of the cricopharyngeal septum in the slot between the blades, permits advancement of the endoscope and cap as one unit and automatically determines when the incision is complete by passage of the cap into the esophagus with the endoscope. The mucomyotomy is performed using a Billroth II sphincterotome, advanced in the axis of the endoscope, together with ErbeÒ Endocut (image 2). At completion of the incision, the cap is removed and up to four endoclips are placed to close the defect. Results: This endotherapy technique was successfully performed in all eight patients. Clinical success at one month was 100%. No adverse events occurred. Symptom evaluation at follow-up (up to three years) revealed no reports of symptom recurrence (dysphagia, regurgitations, cough) and no repeat treatments were required. Discussion: A recent review compared rates of failure, revision and morbidity from endoscopic and open approaches. Failure of endoscopic approaches was 18.4% with a complication rate of 7%, mostly relating to subcutaneous emphysema (3.0 %) and mediastinitis (1.2%). 3 With our technique, clinical remission was achieved in a single session of treatment in all cases and was without complication. Long-term efficacy of the technique is also demonstrated. This technique may become the new standard for endotherapy of Zenker s diverticulum.references:1) Law R, Katzka DA, Baron TH. Zenker s Diverticulum. Clinical Gastroenterology and Hepatology 12 (2014): Print.2) Sakai P, Sakai CM, Furuya CK. Flexible Endoscopic Zenker s Diverticulotomy Using Endoscopic Hood, Overtube, and Hook Knife. Video Journal and Encyclopedia of GI Endoscopy 1.1 (2013): Online.3) Verdonck J, Morton RP. Systematic review on treatment of Zenker s diverticulum. European Archives of Oto-Rhino-Laryngology Sep 7. Online. Mo1510 Efficacy and Safety of Non-Exposed Endoscopic Wall-Inversion Surgery (NEWS) As a Novel Full-Thickness Resection Technique for Gastric Tumor Keiko Niimi*, Susumu Aikou, Shinya Kodashima, Nobutake Yamamichi, Hiroharu Yamashita, Mitsuhiro Fujishiro, Yasuyuki Seto, Kazuhiko Koike The University of Tokyo, Tokyo, Japan Background: Endoscopic submucosal dissection (ESD) has been widely accepted as an effective treatment for gastrointestinal tumors. However, ESD for early gastric cancer (EGC) with ulcer scarring is still technically difficult. Non-exposed endoscopic wall-inversion surgery (NEWS) is an advanced method of endoscopic full-thickness resection (EFTR) without transluminal communication, causing intra-abdominal contamination or possible tumor dissemination, applying ESD technique. The aim of this study is to investigate the efficacy and safety of NEWS for gastric submucosal tumors (SMT). Methods: Between July 2011 and November 2014, 15 patients (5 females, 9 males; mean age 66 years, range years) underwent NEWS for intragastric-type gastric SMT within 4cm in size at the University of Tokyo Hospital. After marking around a tumor on both the mucosal and serosal surfaces and submucosal injection of sodium hyaluronate, circumferential seromyotomy and sero-muscular suturing were made laparoscopically, followed by circumferential muco-submucosal incision endoscopically. The resected specimen was perorally retrieved. Clinical data and pathological features were analyzed. Results: The mean tumor size and resected specimen were 24.2 mm (range, mm) and 34 mm (range, mm), respectively. All lesions were successfully resected in an en-bloc fashion. The mean operation time was 220 minutes (range, minutes), and the mean estimated blood loss was 38 g (range, g). Patients started oral intake on mean postoperative day 2.1 (range, 2-3), and the mean length of postoperative hospital stay was 8 days (range, 6-13 days). Micro perforation occurred in the five cases due to technical inadequacy, which were treated successfully without open surgery. There were no severe complications, such as hemorrhage, anastomosis insufficiency, delayed gastric emptying or surgical site infection. Histopathological examination of the tumors showed GIST (nz14) and schwannoma (nz1). Conclusions: NEWS is an effective and safe full-thickness resection with minimum possible margin without contamination and tumor dissemination into the peritoneal cavity. Although some technical problems need to be improved, NEWS could be utilized as a novel treatment option not only for gastric SMT but also for nodenegative EGC difficult to resect by ESD. The Carr-Locke Cap placed on the end of the endoscope Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB447
53 Mucomyotomy performed using a Billroth II sphincterotome and ErbeÒ Endocut Mo1512 An Endoscopic Gastroplasty for Obesity Treatment Using Endoscopic Suture Device: In Vivo Animal Study In Kyung Yoo* 1, Hoon Jai Chun 1, Yoon Tae Jeen 1, Bora Keum 1, Eun Sun Kim 1, Hyuk Soon Choi 1, Hongsik Lee 1, Chang Duck Kim 1, Ho Sang Ryu 1, Sang Woo Lee 1, Jong-Jae Park 1, Yoonjin Kim 2, Semi Yoon 2 1 Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea (the Republic of); 2 Division of Mechanical Engineering, Korea University, Seoul, Korea (the Republic of) Background/aim: Obesity is a major health problem worldwide. The primary treatment for obese patients is weight reduction, which can improve comorbidity. Procedure to reduce gastric volume has been widely used for surgical treatment of morbid obesity. Recently, it is reported that there is an effect on metabolic diseases such as diabetes. An endoscopic approach to treat obesity may be less invasive than laparoscopy or surgery. We made an endoscopic suture device with suction cap for reducing stomach volume. The objective of this study is to evaluate the feasibility and effectivenss of an endoscopic suturing procedure for weight loss in vivo. Methods: A prototype suture device was created using needle, beads and suction cap. This novel device was used to suture wall of the fundus and body. After suturing, the thread was retracted to reduce the volume and was tied using the knotting device. After the suture procedure, water was reinjected to check the volume of the stomach. And we performed pig studies to evaluate safety and feasibility of this method. Results: We performed ten in vivo animal studies. Mean volume was 1296ml before the experiment, but the volume reduced to 1089ml after the end of experiment. We could confirm about 19 % volume reduction. All of the stitches were securely sutured with partial thickness. The study showed that suturing of full thickness using continuous closure device resulted in the decrease of volume. We performed 10 short term experiments in a porcine model. It is possible to reduce gastric volume in live porcine model, and pigs had been survived for 7w 30 days before sacrifice without complication. There were no technical problems during the procedure. Endoscopic gastric reduction with our device is technically feasible on a live porcine model. Conclusion: It is possible to achieve transoral endoscopic gastroplasty with an endoscopic continuous suture device. Mo1513 High Pressure Carbon Dioxide Submucosal Injection in Endoscopic Submucosal Dissection Toshio Uraoka* 1,2, A. I. Fujimoto 2, Yasutoshi Ochiai 2, Osamu Goto 2, Yoshiro Kawahara 3, Keisuke Hori 3, Shimoda Masayuki 4, Naohisa Yahagi 2 1 Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan; 2 Division of Research and Development for Minimally Invasive Treatment, Cancer Center, School of Medicine, Keio University, Tokyo, Japan; 3 Department of Endoscopy, Okayama University Hospital, Okayama, Japan; 4 Department of Pathology, School of Medicine, Keio University, Tokyo, Japan Background and Aim: Endoscopic submucosal dissection (ESD) can be used for successful en bloc resection of early stage gastrointestinal tumors including large lesions. However, this requires an effective submucosal (SM) injection agent that is safe and effective. We previously reported on the effectiveness of carbon dioxide (CO 2 ) as a SM injection agent during ESD procedure (Dig Endosc 2011). CO 2 was filled into a 50ml syringe and then injected by hand into the SM layer which resulted in physical dissection of that layer. However, additional injection solution was necessary for maintaining the SM cushion based on previous feasibility study (UEGW 2013). We developed a high pressure CO 2 SM injection (HPCSI) technique to facilitate ESD. The aim of this preclinical study was to assess the feasibility of this novel technique in a porcine gastric model. Method: Twelve domestic female pigs of about 30 kg underwent ESD in two groups. Two different areas of artificial lesions measuring 3 3 cm were marked with soft coagulation in each of the six pigs in the two groups. HPCOSI system consisted of a prototype electrosurgical knife which has the gas emitting lumen at the tip of the sheath with a CO 2 insufflationregulatorconnectedtoaco 2 bottle. By alternate allocation, circumferential incision using a prototype electrosurgical knife of HPCSI, followed by SM dissection using HPCSI was performed (HPCSI group). Large vessels in the SM layer were coagulated using the tip of a prototype electrosurgical knife. In the other group, conventional ESD was performed following SM injection of normal saline solution. All procedures were performed by one of two endoscopists who had a different experience of ESDs. The area of the resected pieces was calculated by using the formula for calculating the area of a circle: (Area Z Pi radius 2 )SM dissection speed was calculated by dividing the area of the resected piece in relation to the total dissection time (speed Z area/time). Second look gastroscopy was performed on day 3. Results: All procedure achieved en bloc resection. SM dissection speed was significant faster in the HPCSI group than the control group ( vs cm 2 /sec, pz0.017). According to ESD experience, a more experienced endoscopist achieved SM dissection speed significantly faster ( vs cm 2 /sec, pz0.038), while with a less experienced endoscopist there were no statistically significant difference between the two groups ( vs cm 2 /sec, pz0.103). No perforation occurred and one delayed bleeding occurred in the control group. Second look gastroscopy did not observe any necrotic changes of gastric mucosa around ESD-induced ulcers. Conclusion: A novel HPCSI technique may represent advancement in safe and effective SM dissection procedure. The value of this technique for clinical use awaits further study. Mo1514 Endoscopic Treatment of Severe Upper GI-Bleeding in Anticoagulated Patients Using the Over-the-Scope-Clip (OTSC) - Are WE Entering a New Era? Edris Wedi*, Adrien Sportes, Juergen H. Hochberger Department of Gastroenterology and Endoscopy, University Hospital Strasbourg, Strasbourg, France Introduction: The OTSC (OVESCO, Germany) is a novel endoscopic device successfully applied for severe GI bleedings, perforations, fistulas and experimental NOTES procedures. We performed a retrospective analysis of all OTSC applications for acute gastrointestinal bleeding from February 2009 to March 2014 using our endoscopy database and individual patient records. Aims & Methods: Over a 5 year period 55 patients [median 73 y (29-97) 17 w, 38 m, ASA 2-4] with acute severe upper gastrointestinal bleeding (hemoglobin! 7 g/dl at admission for acute bleeding or as emergency endoscopy for hospitalized patients) using 56 OTSCs (nz54 T-type 12/6 17,5 mm OD; nz2 T-type 14/6 21 mm OD).Results:In 48/55 cases (87.2%) acute bleeding was related to peptic ulcer disease, in 2 cases due to bleeding from a malignant ulcer (1x gastric AC, 1x gastric lymphoma), 2 cases due to recurrent bleeding after polypectomy and clip in the stomach. In 1 case a heavily bleeding Mallory Weiss tear and in 1 case a bleeding ulcer at a gastro-jejunal anastomosis was treated. One patient bled heavily from a deep muscle laceration after balloon dilatation for achalasia. 18/55 (32.7%) were treated due to a failure of a previous hemostasis methods (standard hemoclips, injection or radiologic embolization). Of the 55 patients 44 (80%) were on pre-existing anticoagulation, 9/55 (16.4%) took warfarin, 24/55 (43.6%) aspirin, 10/55 (18.2%) heparin/enoxaparin and 1 (1.8%) was anti-coagulated with a combination of aspirin plus clopidogrel. In 46/55 of all cases, primary treatment with the OTSC was successful (83.6%), in all the cases without re-bleeding events. In 7/55 (12.7%) surgical treatment was necessary due to insufficient hemostasis. However, 4 of those 7 patients died during the hospital stay. 2 multi-morbid patients not fit for surgery passed away. Conclusion: The OTSC system is a promising new tool for the management of acute severe GI-bleeding. Especially patients with pre-existing anticoagulation and multi-morbidity seem to profit from this system. AB448 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
54 Mo1515 Efficacy and Safety of Endobarrier Implantation on Weight Reduction and Glycemic Control Among Obese Type 2 Diabetic Patients Abdulla Alhassani*, Duha Alhamadi, Hala A. Taha, Huda A. Alnuaimi, Mohammed Alnuaimi Zayed Military Hospital, Abudhabi, United Arab Emirates Background: The endoscopically placed duodenal-jejunal bypass endobarrier has been designed to achieve weight reduction and improve glycemic control in obese patients. We reported the first middle east efficacy and safety experience on this device. Methods: Eighteen obese and type 2 diabetic patients included. Seventeen patients underwent endobarrier implantation. A maximum 9 months follow up achieved on 5 patients and 3-6 months on 14 patients. excess weight loss, BMI prior and after procedure, HBA1C, and need for diabetic medications, adverse events were assessed through out the study. Results: Seventeen devices were successfully implanted. In one patient device could not be implanted due to existence of duodenal ulcer. One device was removed after 2 weeks from implantation due to severe bleeding at implantation site. Mean procedure time was 18.7 minutes (12-30 minutes). Initial mean body mass index(bmi, Kg/m2) was Absolute change in mean BMI was 9.21 and Kg/m2 at 3 and 9 months respectively. Mean excess weight loss was 17.1% after 9 months. Initial mean HbA1c was 8.5%. Mean HbA1c was 7.4%, and 6.6% at 3 and 9 months post Endobarrier implantation respectively. Insulin and Hypoglycaemic agents requirements were remarkably reduced during the study period. During the study period of 17 patients, 100% developed at least one adverse event, mainly nausea, and abdominal pain during the 1st month after implantation. Conclusion: Endobarrier implantation is a feasible promising device for achieving significant weight loss and improving type 2 diabetes control. Safety profile of the device seems acceptable. Long term randomized and sham studies are required to further explain efficacy and safety. Change in BMI at baseline and 6 months post endobarrier implantation Mo1516 Success Rate and Predictive Factors for Closure of Full-Thickness Gastrointestinal Defects With a Novel Endoscopic Suturing System Oriol Sendino*, Steve D. Kane, Kenneth Binmoeller, Janak N. Shah, Chris M. Hamerski, Yasser M. Bhat Interventional Endoscopy Services (IES), California Pacific Medical Center, San Francisco, CA Background: Multiple techniques have been used for endoscopic closure of fullthickness gastrointestinal defects, such as leaks, perforations, and fistulae. However, these techniques have shown low success rates, mainly due to the inability to achieve full-thickness closure. Aim: To evaluate a second generation endoscopic suturing device for the management of full-thickness defects. Methods: A retrospective query of a prospective maintained database at a tertiary care medical center was performed. Consecutive patients with a GI defect who underwent endoscopic suturing were studied. A second generation suturing device was used (OverStitch TM, Apollo Endosurgery, Austin, TX). The outcomes measured were: success of the closure (defined as documented closure with a minimum of 2 weeks of follow-up), adverse events and predictors of successful outcome. Results: 43 patients with fullthickness defects were treated from October 2012 to September 2014; 8 patients were lost for follow up and the analysis was performed in the remaining 35 patients (60% female; mean age 58 years). 21 patients (60%) had post-surgical leaks, 7 (20 %) benign post-surgical fistulae and 7 (20 %) had acute perforations. 23 patients (65 %) had upper GI defects (9 esophagus, 10 stomach, 4 duodenum) and 12 (35%) had colorectal defects. 15 patients(43%) underwent previous attempts at surgical repair and 6 (17%) had prior endoscopic closure attempts, without success. The mean estimated size of the defects was 14.7mm (range 4-40 mm). 14 patients (40 %) were treated with the suturing device alone, and 21 (60 %) had combined therapy: fully covered stent placement (nz21) and tissue glue (nz5). Mean number of sutures used was 4.2 (range 1-11) during a mean 1.3 treatment sessions (range 1-3). The mean time between diagnosis and endoscopic suturing was 54 days (range 0-316).The endoscopic closure was successful in 7 perforations (100%), 13 leaks (62%) and 3 fistulae (43%) for an overall success rate of 66% at a median follow-up duration of 2 months (range 1-8). No adverse events were observed. In univariate analysis, treatment success was higher for perforations (vs. leaks or fistulae), and higher with a shorter time interval (!4 weeks) between diagnosis and treatment. The following did not influence treatment outcomes: (1) suturing alone vs. combination therapy, (2) treatment of upper GI vs. colorectal defects, (3) defect size, and (4) prior endoscopic or surgical attempts at closure. In multivariate analysis, a shorter time interval (!4 weeks) between diagnosis and endoscopic closure was the only predictor of success. Conclusion: A second generation endoscopic suturing tool appears safe and effective for the treatment of leaks, perforations, and fistulae. The time from diagnosis of the defect to the endoscopic suturing appears to be a predictor of successful long-term closure. Mo1517 Comparison of Migration RATES of FCSEMS After Stent Anchoring Using a Novel Endoscopic Suturing System (Overstitch TM ) With Standard Stent Placement in Benign Upper GI Disease Oriol Sendino*, Kenneth Binmoeller, Steve D. Kane, Janak N. Shah, Chris M. Hamerski, Yasser M. Bhat Interventional Endoscopy Services (IES), California Pacific Medical Center, San Francisco, CA Background: Fully covered self-expanding metallic stents (FCSEMS) are frequently used to treat benign upper GI (UGI) tract diseases. Although FCSEMS are safe and technically easy to place, spontaneous stent migration remains a problem that may reduce the efficacy and increase costs of the therapy. Aim: To compare the migration rates of FCSEMS after anchoring using a second generation endoscopic suturing device with standard stent placement without anchoring in benign UGI diseases. Methods: A retrospective review of a prospectively maintained database at a tertiary care medical center was performed. The study cohort included consecutive patients who underwent FCSEMS placement with stent anchoring using the second generation suturing device (OverstitchTM, Apollo Endosurgery, Austin, TX). The control group included consecutive patients who underwent FCSEMS placement without anchoring or fixation. The main outcome measured was migration rate of FCSEMS and other outcomes measured were safety and adverse events. Results: 46 patients who underwent FCSEMS placement with stent anchoring from 4/2013 to 10/ 2014 (study group) and were compared to 41 patients who underwent FCSEMS placement without anchoring from 1/2011 to 3/2013 (control group). The baseline characteristics of both groups were similar except for a significantly higher proportion of patients with strictures in the control group (Table 1). Mean number of sutures used for stent anchoring was 2 (range 1-5).Stent placement and anchoring was technically successful in all patients. The overall rate of migration was significantly lower in the study group compared to the control group (17% vs 34%; p! 0.05) during a median follow-up duration of 23 days (range 7-63) and 21 days (range 7-135) respectively (Table 2). There was no difference in the mean number of days to stent migration between both groups. In univariate analysis, the following factors had no influence on stent migration rate in the study group: (1) the absence or presence of a stricture, (2) the location of the stent, (3) the length and width of the stent (3) or the number of sutures. However, the absence of a stricture was associated with a significantly higher stent migration rate in the control group. No adverse events related to stent placement or suturing were observed in either group. Conclusion: Anchoring of UGI FCSEMS using a second generation endoscopic suturing device appears to significantly decrease the migration rate when compared to no fixation. Further studies are needed to assess the clinical benefits and potential costsavings of this strategy. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB449
55 for GB drainage a 10x10mm (9) and a 6X8mm ( 1). Technical success was achieved in 18/19 pts. (94.7%). In one patient in whom the CBD was approach from the stomach, the proximal flange was deployed on peritoneal side of the gastric wall, creating a bile leak. This complication was treated by placing a fully covered stent in the CBD. Clinical success was achieved in 16/18pts. (88.9%). Unsuccessful CBD drainage occurred in 2 patients in whom a stent was placed from the stomach into the gallbladder because GB did not communicate with CBD. Two of the 16 patients with successful CBD drainage required placement of a plastic stent through the Hot-Axios due to intercurrent occlusion and cholangitis, while in the remaining 14 patients the stent was patent or the cholecystitis resolved at the end of follow up. No perforations, bleedings or stent migrations were observed. Conclusion: Onestep fluoroless EUS-guided CBD and GB drainage using the Hot-Axios system in patients with unresectable malignant CBD obstruction after failed ERCP or acute cholecystitis is feasible, safe and efficient. Mo1519 The Efficacy of the Novel Tissue Grasper-Clips Technique for Large Sigmoid Colon Perforations in Experimental Simulation Model Yunho Jung*, Il-Kwun Chung, Young Sin Cho, Tae Hoon Lee, Sang-Heum Park, Sun-Joo Kim Gastroenterology, Soon Chun Hyang Cheonan Hospital, Cheonan, Korea (the Republic of) Background/Aims: Sigmoid colon perforations are difficult to handle because of excess mobility. Therefore, the aim of study was to evaluate the efficacy of the twin grasper-clips technique for large sigmoid colon perforations. Methods: This study was a randomized and controlled study. A total of 35 full-thickness defects were created in ex vivo porcine sigmoid colon specimens. An endoscopist performed conventional endoclip technique (hemoclip group) or the twin grasper-clips technique (twin-grasper group). Results: In hemoclip group (nz20), the mean number of clips ( , , , and , pz0.001) and closure time (5.31.8, , , and min, pz0.001) were significantly difference between 1.5, 2.0, 2.5, and 3.0cm defects. In twin-grasper group (nz15), the mean number of clips (4.01.0, , and , pz0.101) and closure time (7.70.6, , and min, pz0.506) were not significant difference between 2.0, 2.5, and 3.0cm defects. In 3cm defects, the mean number of clips and total closure time were significant smaller and relatively faster in twin-grasper group than hemoclip group. Conclusion: The twin grasper-clips technique seems to reduce the use of hemoclips and relatively faster than conventional technique in large sigmoid perforations Mo1518 One-Step Fluoroless EUS-Guided CBD and Gallbladder Drainage - Change of Paradigm? Markus Dollhopf* 1, Ilaria Tarantino 2, Andres Sanchez-Yague 3, Fabia Attili 4, Alberto Larghi 4 1 Dept. Gastroenterology and Hepatology, Klinikum Neuperlach, Munich, Germany; 2 Endoscopy Unit, Department of Diagnostic and Therapeutic Services, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Palermo, Italy; 3 Gastroenterology Dept, Hospital del Sol, Marbella, Spain; 4 Digestive Endoscopy Unit, Catholic University, Rome, Italy Background and Aims: EUS-guided drainage of unresectable malignant common bile duct strictures (CBD) after failed ERCP and of the gallbladder (GB) in patients with acute cholecystitis unfit for surgery are alternative minimally invasive treatment modalities to percutaneous drainage. Up to now, available EUS-techniques to perform these procedures have required frequent accessories exchange with risk of dislocation and therefore of bile leak and perforation. Our aim was to investigate one-step fluoroless EUS-guided CBD and GB drainage by using a novel lumen-apposing, self-expanding fully covered metal stent incorporated in an electrocautery enhanced delivery system that allows direct puncture of a target, insertion and release in a one-step-fashion. Methods: Retrospective analysis of all consecutive patients with unresectable malignant CBD strictures after failed ERCP or cholecystitis unfit for surgery who were treated by EUS-guided placement of Hot-Axios TM (Xlumena Inc., Mountain View, California, USA). All procedures were performed without fluoroscopy using EUS and endoscopic guidance. Technical success was defined by adequate placement of Hot-Axios-Stent with established drainage. Clinical success was defined by R80% decrease of obstructive parameters or resolution of cholecystitis. Results: 19 patients (Mean age 75yrs; M/F: 10/ 9) with malignant obstructive jaundice (13) and cholecystitis (6) were included. CBD access was used in 9 pts. (8 transduodenal, 1 transgastric) and GB access in 10 pts. For CBD drainage a 6x8mm (3), 8x8mm (3) and 10x10mm (3) were used while The results of twin-grasper and hemoclip groups Groups Each (N[5) 2cm hemoclip 2cm twingrasper Number of endoclips Procedure time (min) Endoscopical fail Complete closure in water leak % 60% % 80% P cm % 60% hemoclip 2.5cm twingrasper % 60% P cm % 40% hemoclip 3cm twingrasper % 60% P AB450 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
56 ESD procedure, a solution such as saline or sodium hyaluronate is usually injected into the submucosal layer to avoid the risk of perforation. However, ESD using electrosurgical knives has problems such as the technical difficulty and the high rate of perforation especially for beginners. On the other hand, carbon dioxide (CO 2 ) laser has been widely used for clinical surgery. Aims & Methods: The aim of this study was to develop a novel and safe method for ESD by using selective interaction caused by wavelength dependent absorption of laser in the mid-infrared wavelength range. In this study, CO 2 laser with a wavelength of 10.6 mm was chosen because it is suitable for incision and coagulation, and is strongly absorbed by the water. We hypothesized that performing ESD using CO 2 laser with a submucosal laser absorber could be a safe and simple ESD technique. To provide proof of concept regarding the feasibility of this novel method, an experimental study in vitro and in vivo porcine model was performed. A hollow optical fiber (J. Morita Mfg. Corp., Kyoto, Japan) optimized for the wavelength of the CO 2 laser was used in this study. The inner diameter of the fiber was 530mm and the fiber can simultaneously transmit a visible laser as a guide laser. (1) In-vitro experiment: A resected porcine stomach was used as a sample. The laser irradiation was performed at output power 3W at a distance 2mm from the mucosal surface under these conditions, with or without injection of saline into the submucosa. The depth of incision was measured during each procedure. (2) In-vivo experiment: LWD pigs weighing 18.5kg were used under general anesthesia. A hollow optical fiber was passed through the endoscope (GIF-Q260J, Olympus, Tokyo, Japan) channel, and ESD using CO 2 laser was performed to the gastric and esophageal hypothetical lesions. The collected samples were evaluated histologically. Results: (1) Perforation was only observed without submucosal injection. (2) ESD for both stomach and esophagus were accomplished without any complications such as perforation, serious bleeding and significant thermal damage. Conclusion: ESD using CO 2 laser with submucosal laser absorber might be a feasible and safe method for the treatment of early gastrointestinal tumors. Mo1520 New Technique for GI Endoscopy Using 3D Printing Joo Young Cho* 2, Jun Hwan Yoo 2, Duk Hwan Kim 2, Kim Wonhee 2, Kwang Hyun Ko 2, Ki Baik Hahm 2, Sung-Pyo Hong 2, Pil Won Park 2, Jun-Hyung Cho 1, Weon-Jin Ko 2 1 Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea (the Republic of); 2 Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam-si, Korea (the Republic of) Background and Study Aim: Cap assisted endoscopic mucosal resection (EMRC) procedure is a less invasive, valuable treatment modality of esophageal mucosal lesion. But it is difficult to target accurately the lesion because esophageal lesion is located vertically to the insertion direction of the endoscope. So we started to develop novel endoscopic caps using 3D printer which were tailored manufacturing on demand of endoscopist. The aim of this study was to evaluate the feasibility of various novel endoscopic accessories using 3D printing technique. Patients and Methods: A total of 14 patients underwent cap assisted endoscopy (CAE) by a single expert endoscopist. Procedure details were cap assisted endoscopic mucosal resection (EMRC) (nz3), endoscopic submucosal dissection (ESD) (nz8), and trucut biopsy (TCB) (nz3). Instead of conventional endoscopic cap, the designing and fabricating custom-made caps by a 3D printer was used for each procedure. Three types of 3D printing cap were used; disposable distal attachments; we named them each, Side hole cap, Oblique head cap and Wide head cap. Result: EMRCs in esophagus (nz2) and gastro-esophageal junction (G-E junction) (nz1) were completed with Side-hole cap. The median total procedure time was 20 minutes (range 8-50). Pathologic diagnosis included esophageal leiomyoma (nz2), differentiated adenocarcinoma (nz1). Curative resection was achieved in 3/3 patients (100%). All ESDs in stomach (nz8) were completed with Oblique head cap. The median total procedure time was 53 minutes (range 26-92). The final pathologic mapping revealed differentiated adenocarcinoma (nz5), carcinoma with lymphoid stroma (nz2) and low grade dysplasia (nz1). All of these cases were resected en bloc. Curative resection was achieved in 7/8 patients (87.5%). TCBs in esophagus (nz3) were completed with Wide head cap. All pathologic diagnosis of TCBs were leiomyoma (nz3). Overall technical success rate for diagnosis was 100% (nz3/3). There was no significant complication, such as bleeding or perforation. Conclusion: The novel endoscopic caps using 3D printing technology were feasible in diagnostic or therapeutic GI endoscopy. Mo1521 Development of Novel Method for Endoscopic Submucosal Dissection Using Carbon Dioxide LASER Yoshinori Morita*, Tetsuya Yoshizaki, Takeshi Azuma Kobe University School of Medicine, Kobe, Japan Introduction: Recently, endoscopic submucosal dissection (ESD) has been widely accepted as a less-invasive treatment method for early gastrointestinal tumors. In Mo1522 Clinical Experience in the Endoscopic Treatment With Over-the- Scope-Clips (OTSC)â in Iatrogen Perforation, Leakage and Severe Bleeding in the Gastrointestinal Tract Johannes Stueckle*, Andreas Probst, Maximilian Bittinger, Alanna Ebigbo, Helmut Messmann, Stefan Goelder Department of Internal Medicine III, Klinikum Augsburg, Augsburg, Germany Background: The treatment of iatrogen perforation, anastomotic leakage and fistula in the gastrointestinal tract is more and more becoming an endoscopic issue. First studies show the effectiveness and safe application of the Over-the-Scope-clip (OTSC, Ovesco, Tübingen, Germany). Moreover, the system can be used in severe gastrointestinal bleeding. In our study, we show our experience and the clinical outcome of patients treated by OTSC. Method: We retrospectively analysed the data of patients (pts) who underwent treatment with OTSC in the upper and lower gastrointestinal tract in our hospital during the period from 12/2009 to 09/2014. Results: We treated n Z 34 pts ranged in the age from 30 to 88 years (median: 70 years, mz19) due to perforation, leakage and fistula in the upper and lower gastrointestinal tract. Moreover, patients with relapsing severe upper gastrointestinal bleeding are included in our study. In a total of 8 cases, perforation occured during diagnostic and therapeutic endoscopy, such as polypectomy or ERCP, and indicated the closure by OTSC-clip. In 7 of 8 of these complications (87,5%), OTSC-clipping closed the lesion successfully and no additional surgical or interventional treatment was needed. One patient suffered from persisting duodenal leakage. The additional treatment with a drainage was necessary.in n Z 20 cases, OTSC clipping was performed due to anastomotic leakage or chronic fistula. The reasons for these interventions were very various, named as anastomotic leakage after bariatric, esophageal, pancreatic, colonic and aorta surgery as well as cholecystectomy (n Z 9). A sufficient closure was reached in 9 cases. Chronic fistula due to acute pancreatitis, persisting leakage after removal of an infected percutanous endoscopic gastrostomy, chronic enterocutanous fistula, rectovaginal fistula, chronic anastomotic leakage in a Crohn s disease patient, spontaneously perforated gastric ulcer and a colonic perforation of unknown reason relapsed in 8 of 11 cases.besides perforation and leakage, OTSC-clipping was also performed as a second-line therapy in severe upper gastrointestinal bleeding. 5 patients relapsed after conventional endoscopic hemostasis of duodenal and gastric ulcers. An immediate bleeding stop was reached in all cases. In two cases, patients underwent surgery afterwards because of severe reactivation or the high risk rebleeding situation. One additional patient was treated in a bleeding situation after removal of a duodenal neuroendocrine tumor. The bleeding stopped without any relapse. Conclusion: Our results support the effectiveness of OTSC-treatment in early lesions such as iatrogenic perforation and anastomotic leakage. Another promising approach is the treatment of upper gastrointestinal bleeding. As far as chronic fistula are concerned, the effect of OTSC remains an option for individual cases. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB451
57 Mo1523 Prevention of Bleeding After Endoscopic Submucosal Dissection for Gastric Neoplasms Using Polyglycolic Acid Sheets and Fibrin Glue Yosuke Tsuji* 2,1, Mitsuhiro Fujishiro 2,1, Yosuke Kataoka 1, Itaru Saito 1, Yoshiki Sakaguchi 1, Chihiro Minatsuki 1, Itsuko Hirayama 1, Keiko Niimi 3, Satoshi Ono 1, Shinya Kodashima 1, Nobutake Yamamichi 1, Kazuhiko Koike 1 1 Gastroenterology, Graduate School of Medicine, the University of Tokyo, Bunkyo-ku, Japan; 2 Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan; 3 Center for Epidemiology and Preventive Medicine, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan Background: For bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms, no preventive method has been established other than preventive coagulation of visible vessels on the artificial ulcer after ESD or the usage of proton pump inhibitors. We have reported that the endoscopic tissue shielding method with polyglycolic acid (PGA) sheets and fibrin glue can reduce the risk of post-esd bleeding. Aim: To evaluate the efficacy of PGA sheets and fibrin glue for preventing bleeding after gastric ESD after accumulating more cases. Methods: This is a nonrandomized historical controlled study. We defined high-risk patients for post-esd bleeding as follows: 1) those who took antithrombotic drugs regularly; or 2) those expected to undergo large mucosal resection (R 40mm). We enrolled patients scheduled to undergo gastric ESD and had above-mentioned risk factors from July 2013 as the study group (Group A). Immediately after ESD we placed PGA sheets on the mucosal defect and fixed them with fibrin glue in the study group. We extracted high-risk patients from those who had undergone gastric ESD at our institution before the enrollment of the first study patient, and defined the group as the historical control group (Group B). The post-esd bleeding rate was the primary endpoint in comparative analysis. Results: From July 2013 to October 2014, 98 ESDinduced ulcers in 91 high-risk patients were enrolled in Group A. In Group B, 91 ESD-induced ulcers in 84 consecutive patients were extracted between January 2012 and July There was a significant difference in antithrombotic drugs use (A: 62 lesions, 63.3%, B: 44, 48.4%; P Z 0.039), but the other baseline characteristics were not significantly different between the two groups: sex (A: male 86/female 12, B: male 73/female 18; P Z 0.156); age (A: yrs, B: yrs; P Z 0.229); Heparin bridging therapy (A: 18 lesions, 18.4%, B: 10, 11.0%; P Z 0.151); and the diameter of resected specimens (A: mm, B: mm; P Z 0.094). Perforation did not occur in either group. Post-ESD bleeding occurred in 7.1% of the study group (7 lesions), and 17.6% of the historical control group (16 lesions). There was a significant difference in the post-esd bleeding rate between the two groups (P Z 0.027). Multivariate logistic regression analysis also confirmed that applying PGA sheets and fibrin glue was an independent significant factor for decreasing the risk of post-esd bleeding (Odds Ratio, 0.33; 95% CI: , P Z 0.029). The mean procedural time for applying PGA sheets and fibrin glue was min. Conclusion: Even after accumulating more cases, this study all the same implied that the endoscopic tissue shielding method with PGA sheets and fibrin glue might be promising for the prevention of post-esd bleeding. Mo1524 Endoscopic Stomach Volume Estimation for Bariatric Endoluminal Gastroplasty: Animal Validation Study Seung-Joo Nam* 1, Hoon Jai Chun 1, Dokwan Lee 2, Yongnam Song 2, Seung Han Kim 1, Jae Min Lee 1, In Kyung Yoo 1, Hyuk Soon Choi 1, Eun Sun Kim 1, Bora Keum 1, Yoon Tae Jeen 1, Hongsik Lee 1, Chang Duck Kim 1, Sang Woo Lee 1, Jong-Jae Park 1 1 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea (the Republic of); 2 Department of Mechanical Engineering, Korea University, Seoul, Korea (the Republic of) Background: The shape of stomach is variable among individuals and conditions, so estimation of stomach volume is still difficult even though the recent development of various imaging modalities (CT or MRI). We proposed the possibility of endoscopic stomach volume estimation previously (Digestive Disease Week 2014, Mo1154). In this study, we aimed to validate the accuracy and value of endoscopic stomach 3D reconstruction and volume estimation using extracted porcine stomachs. Methods: Three extracted porcine stomachs were used to test the accuracy of endoscopic stomach volume estimation. First, internal dimensions of porcine stomachs were measured using endoscopic guide-wire. Then, 3D stomach models were reconstructed using 3D graphic software (Cinema4D R12, MAXON Computer, Germany). Stomach volumes were estimated from the reconstructed 3D models and these results were compared with the real volumes measured by filling the stomach with water. Second, we performed bariatric gastroplasty using our novel endoscopic suture device (Endoscopy 45(8): ), aiming to reduce the stomach volume by 30%. In this step, we took advantage of previously constructed 3D stomach model by simulating the most suitable gastroplasty for predetermined volume reduction. After gastroplasy, real volume of deformed stomachs were measured by filling with water. Results: Stomach volume estimation by endoscopy was relatively accurate (mean error was about 10% of stomach volume). In addition, planned bariatric gastroplasty for predetermined stomach volume reduction by endoscopic suture device was possible with the help of simulation using 3D graphic software, which was not feasible by random suturing. Conclusion: Endoscopic stomach 3D reconstruction and volume estimation was useful, accurate method, which can be used for the future tailored bariatric treatment. Mo1525 Endoscopic Full-Thickness Resection for the Treatment of 32 Cases With Gastric Tumors Originating From the Muscularis Propria Layer Xiao-Yan Wang*, Ding-Hua Xiao, Hua Jiang, Hui Meng Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China Objective: To evaluate the theraputic efficacy and safety of endoscopic full-thickness resection (EFR) for gastric tumors originating from the muscularis propria (MP) layer. Methods: From November 2011 to August 2014, 32 cases with gastric tumors originating from muscularis propria layer ( cm in diameter) were enrolled and treated with endoscopic full-thickness resection (EFR)by using HybridKnife. The tumor resection rate, complications as well as endoscopic perforation closure rate and time were retrospectively analyzed. Results: 32 patients, including 13 male and 19 female, were aged from 38.3 to 74.6 years old, and the average age was years old. Of them, 21 cases of tumors were located in gastric fundus, 7 in the gastric body and others founded in the gastric antrum. All of them were en block resected by EFR. The perforation size was ranged from 0.3 to 2.5 cm in diameter, which could be closed with Titanium clips and Nylon rope. The average operation time was min and the average endoscopic perforation closure time was min. The perforation occurred at gastric antrum with O1.2cm in diameter or at the back wall of gastric body with O2.5cm in diameter is more difficult to close and requires more time. No bleeding and perforation were observed after EFR and none of the patients needed surgical treatment. The average hospital stay was days. Out of the 32 cases, 1 case of gastric muscularis propria was diagnosed as pancreas ectopia. The others were diagnosed as stromal tumors either by pathological test or immunohistochemistry (1 moderate invasion risk, 30 low invasion risk, among them 2 smooth muscle differentiation tendency). Conclusion: EFR is a safe and effective approach for gastric tumors originating from muscularis propria layer. Mo1526 Novel Use of a Removable Lumen Apposing Metal Stent (LAMS) for Management of Gastroduodenal and Bariatric Anastomotic Strictures Mustafa A. Arain* 1, Nabiha S. Shamsi 4, Stuart K. Amateau 1, Tom Fang 1, Brooke Glessing 3, Shawn Mallery 1, Martin L. Freeman 1, Sayeed Ikramuddin 2, Daniel B. Leslie 2 1 Gastroenterology, University of Minnesota, Minneapolis, MN; 2 Surgery, University of Minnesota, Minneapolis, MN; 3 Gastroenterology, Case Western Reserve University, Cleveland, OH; 4 Internal Medicine, University of Minnesota, Minneapolis, MN Introduction: Endoscopic management of benign (Bn-S) or indeterminate (Ind-S) gastro-duodenal strictures (GD-S) resulting in gastric outlet obstruction (GOO) and benign post-bariatric anastomotic strictures (AS) is limited by the lack of an ideal stent. Esophageal fully covered self-expanding metallic stents (FCSEMS) are usually too long, difficult to place and may migrate even when secured with clips or endoscopic sutures. A lumen apposing metal stent (LAMS) designed primarily for drainage of fluid collections offers an alternative approach. Aim: To describe the role of the LAMS in the management of GOO and benign AS. Methods: All patients (pts) with a Bn-S or Ind-S with GOO or an AS were considered for a LAMS. Pts with known malignant strictures (Mal-S) due to pancreatic cancer were excluded. All pts reported intolerance to solids. After endoscopic evaluation, a 15 mm lumen, 10 mm length, 24 mm flange LAMS (Axios Ò, Xlumena, Mountain View, CA, USA) was placed under AB452 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
58 endoscopic and fluoroscopic guidance. Symptom response and procedure and stent related outcomes were measured prospectively. Results: 11 patients (9 F, 2 M) were treated with a LAMS from Apr-Nov pts had GOO (Bn-S Z 1, Mal-S Z 1, Ind- S Z 4) and 5 had ASs (gastro-jejunal post Roux-en-Y gastric bypass (RYGB) Z 4, gastric post vertical banded gastroplasty (VBG) Z 1). Obstructive symptoms resolved in 10 pts; there was no response in 1 pt with extrinsic duodenal compression from metastatic sarcoma. Stent removal was possible in all 9 pts in whom it was attempted. 4 pts had LAMS placed more than once; LAMSs were removed for stricture re-evaluation and a new LAMS placed simultaneously in 2 pts, and LAMSs were removed and replaced28 days later for symptom recurrence in 2 pts (benign GOO and AS in RYGB). Mean duration of LAMS in-situ (cumulative time used for the 2 pts with simultaneous Ax-Ss) was 62 days (range ). There were no stent related complications including occlusion, migration or perforation. 1 pt with a radiation induced Bn-S with GOO was treated with a LAMS followed by an esophageal FCSEMS through the lumen of the LAMS with the LAMS acting as an anchor for the FCSEMS, without migration at 6 months. In the 4 pts with Ind-Ss with GOO, a Mal-S was confirmed by EUS-FNA in 1 pt and surgery in 1 pt, a peptic stricture in 1 pt and follow-up is pending in 1 pt. Amongst AS pts, the LAMS was removed for persistent pain (onset pre-dated LAMS) in 1 pt, for AS resolution in 2 pts and was left in place long term in 2 pts (one after initial stent removal). Conclusions: LAMS offers a new option for focal strictures causing GOO or occurring after surgery and have the advantages of easy placement and removal, if necessary, with no associated complications on short-term follow-up. Furthermore, the stent offers an easy new option for anchoring FCSEMS in strictures requiring a longer stent. Mo1527 Gauze Ball Compression: a New Method of Rescue Endoscopic Hemostasis for Nonvariceal Gastrointestinal Bleeding Hyunsoo Chung*, Da Hyun Jung, Jun Chul Park, Sung Kwan Shin, Sang Kil Lee, Yong Chan Lee Severance Hospital, Yonsei University, Seoul, Korea (the Republic of) Introduction: Direct compression of a bleeding site is the most fundamental hemostatic method. Despite this, endoscopic methods based on this principle have yet to be reported. We developed a new mechanical compression hemostatic method using gauze ball compression Patients and Methods: A total of 37 patients (29 male, 8 female) with Forrest classification Ia or Ib bleeding after primary failure of the endoscopic hemostasis was enrolled to this study. A gauze ball was prepared as shown in figure, then grasped by alligator forceps and held at the tip of the endoscope. The prepared endoscope was then inserted into the stomach through an overtube and the gauze ball was used to mechanically compress the bleeding for 3 minutes. The rate of technical success, 30-day rebleeding and mortality were investigated. Results: Mean age of the patients were and the causes of bleeding were peptic ulcer (nz26), cancer (nz7), rectal ulcer (nz2), intra-esd bleeding (nz1) and post-esd bleeding (nz1). Reasons for initial treatment failure (multiple choice) were continuous active oozing after clipping (nz21), fragile mucosa (nz15), hard ulcer base (nz7), failure in identification of exact bleeding focus (nz2). Most common method of initial treatment was combination of epinephrine injection and hemoclipping (nz18). Technical success rate of gauze-ball compression method was 97.3% (36/37), and the rates of 30-day rebleeding and mortality were 2.8% (1/36) and 0%. The patient with rebleeding had unexplained bleeding tendency and oozing from rectal polypectomy site continued after gauze ball hemostasis. Subsequently, transanal primary closure was done. Even after primary closure, oozing continued from stitch sites, and then gauze ball compression was tried again and finally succeeded in hemostasis. Conclusion: Rescue endoscopic bleeding control using hemostatic gauze ball compression is effective for controlling non-variceal gastrointestinal bleeding. Development of proper instrumentation is needed to apply this method more conveniently. Mo1528 Use of Hemospray in Intractable Upper GI Bleeding: U.S. Single Center Experience Sunguk Jang*, Mansour A. Parsi, Tyler Stevens, John J. Vargo Gastroenterology, Cleveland Clinic, Cleveland, OH Background: The endoscopic management of acute upper GI bleeding remains as a significant challenge. At present, endoscopic hemostasis is reserved for those presenting with a few localized lesions as the source of their GI bleeding. HemosparyÒ (Cook Medical, North Caroloina, USA) is an attractive addition to endoscopic hemostasis armamentarium given its ease of use and the potential to broaden the range of patients who may achieve hemostasis by endoscopic method. The application of Hemospray in U.S. is reserved for compassionate use, with the approval obtained in case by case manner. We present a case series from a single U.S. center reporting the outcome Hemospray use in patients with intractable acute upper GI bleeding. The aim of this study is to assess efficacy of Hemospray in managing acute upper GI bleeding where conventional methods failed to achieve hemostasis. Methods: From May 2013 to June 2014, medical records of the patients who received Hemospray as salvage treatment for their acute upper GI bleeding were reviewed. The indication for the Hemospray use were reviewed and acknowledged by the IRB in our institution. The source of bleeding, success rate of initial hemostasis, rate of rebleeding, and 30 day mortality were analyzed. Results: A total of 5 patients (n Z5) received six Hemospray treatments from our institution. All five patients were inpatients who failed to achieve hemostasis with conventional endoscopic hemostasis methods. They were all deemed either a non-surgical candidate or having a bleeding source not amenable for effective angiographic embolization. Two patients showed bleeding source from GE junction (one from anastomotic ulcer and the other from grade IV esophatitis in the setting of coagulopathy due to cirrhosis). One patient bled from duodenal anastomosis site of his recent pancreas transplant. The other two patients had gastric source - one with cirrhosis and severe portal hypertensive gastropathy and the other with multiple gastric angiodysplaisa from HHT. All 5 patients achieved successful initial hemostasis (100%) using Hemospray. One patient (with GE junction anastomotic ulcer) rebled (20%) within 30 days of initial application, requiring re-treatment which was successful. One patient (cirrhotic patient with grade IV esophagitis) died within 30 days of the treatment with the cause of death unrelated to GI bleeding. The other 4 patients were successfully discharged from hospital after the treatment. The HHT patient showed recurrence of bleeding on a subsequent EGD several weeks later. Conclusion: Hemospray is an attractive addition to the field of endoscopic hemostasis. It has potential to be used as an adjunct to existing endoscopic treatment options, or as a salvage therapy for acute GI bleeding ranging from focal lesions to more diffuse etiology, hence broadening our ability to manage acute upper GI bleeding. Mo1529 The Efficacy of Hemospray in Patients With Upper GI Bleeding From Tumor: a Matched-Pair Case-Control Study Rapat Pittayanon*, Piyapan Prueksapanich, Rungsun Rerknimitr, Pinit Kullavanijaya Division of Gastroenterology, Department of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital The Thai Red Cross, Bangkok, Thailand Background and Objective: The appropriate standard treatment for tumor related GI bleeding is either surgery, embolization or radiotherapy; unfortunately, the frail condition of these patients during the initial presentation is the main limitation to immediately undergo for the standard treatment. Therefore bridging therapy is required during resuscitation and stabilization of the patients, unfortunately all conventional endoscopic methods including coaptation therapy, argon plasma coagulation, and mechanical hemostasis provide an unpleasant outcome. Recently, Hemospray known as a non-absorb and non-organic powder, is proposed as a novel endoscopic hemostasis for active gastrointestinal (GI) bleeding, mostly for ulcer bleeding. This study aimed to compare the efficacy of Hemospray with the conventional endoscopic treatment in patients with upper GI bleeding from tumor. Methods and Procedures: From January to September 2014, 12 patients presented with active upper GI bleeding from tumor. Hemospray was applied at the bleeding site until hemostasis was achieved but not more than 20 gram (one cartridge) in each. Three patients were excluded because they received either chemoembolization or radiation therapy the day after, though there was no re-bleeding before they electively underwent these additional therapies. Another 9 patients from historical control were selected for a match based on the type of GI tumors (upper GI tumor and hepatico-pancreatic tumor) and patients age. Blatchford score, amount of blood transfusion, number of endoscopy needed, and the requirement of additional interventions including endoscopy, surgery, adjuvant embolization, and radiotherapy during admission were analysed. The 14- and 30-day re-bleeding rates, length of hospital stay (LOS) and mortality rate at the 30-day follow up were assessed. Results: In both groups (nz18), the upper GI tumors were adenocarcinoma of esophagus (nz1) and stomach (nz9) whereas hepatico-pancreatic tumors were hepatoma (nz4), Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB453
59 cholangiocarcinoma (nz2), pancreatic cancer (nz1) and gallbladder cancer (nz1) invading duodenum. The baseline characteristics including age, location of bleeding tumor, and Blatchford score were not different in both groups. There was a trend toward lower re-bleeding at 14 days (pz0.06) and 30 days in the Hemospray group (pz0.22). No additional interventions needed in the hemospray group during admission. The 30-day mortality rate in the hemospray group was three times lower than the conventional therapy group. (Table). Conclusions: Hemospray is a promising therapy for the initial hemostasis in upper GI bleeding from tumor as it can hold the hemostasis during the first 30 days and this may allow enough time before consideration to provide the appropriate additional intervention. Table. Parameters and outcomes in Hemospray versus non-hemospray treatment Parameters and outcomes Hemospray group (N[9) Conventional endoscopic treatment group (N[9) p- value Age (meansd; years) Sex (%male) Blatchford scores(meansd) Total blood transfusion (meansd;unit) Number of total EGD (meansd) Additional intervention performed during first 10- day (%) Additional intervention performed during admission (%) 14-day re-bleeding rate (%) day re-bleeding rate (%) Length of hospital stay (meansd;day) 30-day mortality rate (%) healing after endoscopic submucosal dissection (ESD). Complications from ESD, however, may prevent patients from commencing the prescribed course of three oral ingestions per day immediately after an ESD is performed. Aims: In this preclinical study we developed a novel 2% rebamipide solution for submucosal injection agent in ESD, used it for ESD experimentally in porcine stomachs,and examined the quality and speed of ulcer healing after the procedure. Methods: Three domestic female pigs of about 30 kg underwent ESD. ESDs of 30 mm in diameter were performed at four sites (anterior and posterior walls of both the upper body and lower body) in the stomach of each of three pigs. An endoscopist blinded to the test agents performed the ESD with matrix alone at two sites (control group) and with the 2% rebamipide solution at the other two sites (rebamipide group). One pig was sacrificed 1 week later (pig 1) and two pigs were sacrificed 4 weeks later (pigs 2 and 3). Examination 1: We evaluated healing speed once a week using endoscopic ulcer staging. Examination 2: We evaluated the quality of the ulcer scar histopathologically. Result: Examination 1. Ulcer healing evaluated by ulcer staging in the rebamipide group was as follows: at 1 week, H1, A2 in pig 1, H1, A2 in pig 2, and A2, A2 in pig 3; at 2 weeks, H2, H1 in pig 2 and H2, H2 in pig 3; at 3 weeks, S1, S1 in pig 2 and S1, S1 in pig 3; at 4 weeks, S1, S1 in pig 2 and S2, S2 in pig 3. The corresponding evaluation in the controls was as follows: at 1 week, H1, A2 in pig 1, H1, A2 in pig 2, and A2, A1 in pig 3; at 2 weeks, H2, H2 in pig 2 and S1, A2 in pig 3; at 3 weeks, S1, S1 in pig 2 and S2, H1 in pig 3; at 4 weeks, S1, S1 in pig 2 and S2, H2 in pig 3. There were no significant differences between the rebamipide group and control group evaluated by ulcer staging, but the folds into the center of the ulcer scar were smoother and more uniform in the rebamipide group than in the control group at 4 weeks after the ESD. Examination 2. The ulcers at 1 week were not observably different between the two groups. At 4 weeks, however, mucosal healing was conspicuously better in the rebamipide group than in the control group, with a thicker and more uniform mucosal layer. Conclusion: The 2% rebamipide solution assessed as a novel submucosal injection agent in this study increased the healing speed and improved ulcer healing after ESD. Mo1531 Feasibility of Using a Novel Triangulation Device to Perform Flexible Endoscopic Suturing in a Porcine Model Mostafa Ibrahim* 1, Vincent Huberty 1, Martin Hiernaux 2, Alexandre Chau 2, Jacques Deviere 1 1 Gastroenterology, Hepatopancreatology and Digestive oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium; 2 Endotools therapeutics, Gosselies, Belgium Introduction: Endoscopic suturing was reported recently but full thickness gastric sutures are still challenging due to the complexity of suturing maneuvers and lack of instrumental handiness, the latter could be reduced with a flexible triangulation system. Aim: To explore the technical feasibility of a novel triangulation platform ENDOMINA Ò to perform full thickness endoscopic suturing and anterio-posterior apposition into the stomach. Methods: ENDOMINA Ò (Endo Tools Therapeutics, Belgium) is a single usetriangulation platform,assembled on the endoscope into the stomach, that adds a 5 Fr bendable channel and a 5 Fr non bendable channel to an endoscope. ENDOMINA Ò is used in combination with TAPES Ò (Transmural Anterio-Posterior Endoscopic Stitcher) in the bendable channel with a preloaded tag and tightening system releaser. The steps of the procedure were (i) Identification of the anterior and posterior piercing points in the stomach. (ii) Mucosal ablation with coagulation current. (iii) Grasping of first point (iv) Introduction of TAPES in the bendable channel. (v) Transmural piercing and deposition of first tag. (vi), Repetition of the same technique at the second point. (vii) Release and tightening of both transmural plicatures using the preloaded knot (viii). Results: Two complete sutures with knot release were achieved in 2 pigs. Mean time for the procedure was 90 minutes. Endoscopy follow up at 7 and 30 days confirmed the presence of the sutures in place and persistent antero-posterior application of the 2 transmural plicatures. Both pigs were sacrificed and tissue histology of resected suture area confirmed full thickness tissue apposition and fibrosis formation. No mortality or procedure related morbidities were reported in the 2 pigs with one month follow up. Conclusion: ENDOMINA-assisted endoscopic system can perform safely endoluminal suturing and knot-tying in live porcine models, achieving not only plicatures with serosa to serosa apposition but also antero-posterior apposition of the plicatures. Mo1530 Efficacy of a 2% Rebamipide Solution As a Novel Submucosal Injection Agent for Gastric Endoscopic Submucosal Dissection Ai Fujimoto*, Yasutoshi Ochiai, Osamu Goto, Toshihiro Nishizawa, Rieko Nakamura, Tadateru Maehata, Satoshi Kinoshita, Seiji Sagara, Toshio Uraoka, Naohisa Yahagi Keio University, Tokyo, Japan Background: Rebamipide is a safe and widely used medication for oral administration to patients with gastritis or gastric ulcers. A combination therapy of proton pump inhibitor (PPI) and rebamipide was reported to effectively promote ulcer AB454 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
60 Mo1532 Feasibility and Usefullness of Application of Oxidized Cellulose (Surgicell) to Treat and Prevent Hemorrhage After Large Endosocpic Colorectal Resections Seiichiro Abe* 1,2, Ivan Jovanovic 2, Helmut Neumann 2, Yutaka Saito 1, Monkemuller Klaus 2 1 Endoscopy, National Cancer Center, Tokyo, Japan; 2 Basil I. Hirschowitz Endoscopic Center of Excellence, University of Alabama, Birmingham, AL Background: The most common complication of endoscopic resection (ER) of large colorectal polyps is bleeding, especially in patients who must continue anticoagulation medications for thrombophilic or cardiovascular disorders. Oxidized cellulose (OC) mesh (SurgicellÒ) is a well-known and widely available surgical hemostatic agent. OC, which has bactericidal activity, exerts its effect as a tissue-apposing device. OC is used to stop bleeding from liver lacerations, gynecological surgery and in neurosurgical interventions. Therefore, it use in endoluminal GI interventions is appealing. Aim: To evaluate the feasibility of endoscopic application of OC and the hemostatic efficacy after endoscopic resection (endoscopic submucosal dissection or piecemeal endoscopic mucosal resection). Materials and Methods: Retrospective, observational, open label, single-center study of patients undergoing endoscopic resection of large rectal and rectosigmoid lesions. After the colorectal epithelial neoplasm removed, OC was applied onto the submucosal surface using one of two methods: a) anoscope or cap-assisted delivery. In both techniques, a hemoclip was advanced through the working channel of the scope and 10 x 10 to 20 x 20 mm large pieces of the OC were grasped with the clip and then delivered and attached to the wound. Results: A total of 12 patients (8 male, 4 female, mean age 64, range 48 to 87) underwent endoscopic resection (ESD, nz8 or piecemeal EMR, nz4) of large rectum or rectosigmoid lesions with either primary intent of complete resection or debulking (in the case of large mucin-secreting rectal tumors). All patients were on anticoagulants and/or antiplatelet agents. The mean size of the lesions was 40 mm, range 30 to 120 mm. An endoscopic R0 was achieved in 75%. (50.0%) underwent the Surgicell Ò application. During follow-up period there were no rectal bleeding episodes or adverse events, despite patients continuing on anticoagulant therapy. Conclusions: OC can be successfully applied to large resection sites using the capassisted or anoscope techniques. OC effectively decreases hemorrhage and prevents post-endoscopic resection bleeding. Thus, this feasibility study suggests that OC may be a valuable tool to provide hemostasis and prevent bleeding after ESD. Now prospective and randomized studies are warranted. Mo1533 Endoscopic Treatment of Large Esophageal Diverticula Using a Magnetic Anastomosis Device: Report of Three Cases Simon Bouchard*, Vincent Huberty, Daniel Blero, Jacques M. Deviere Gastroenterology, Erasme Hospital, Anderlecht, Belgium Introduction: Symptoms of esophageal diverticula can be particularly disabilitating, especiallyin patients with large diverticula. Nowadays, Zenker s Diverticulum can be treated byflexible endoscopy. Aim: Magnets could possibly have a role in treating patients with large esophageal diverticula bycreating a magnetic compression anastomosis between the base of the diverticulum and theesophagus and allowing full marsupialization by completing the section of the septum. Methods: A first magnet is mounted on a catheter and advanced over a guidewire intothe stomach. The endoscope is introduced in the esophagus with the second magnet alreadyattached at the tip of the endoscope. After this magnet has been placed at the base of thediverticulum, the magnet in the stomach is slowly pulled back under fluoroscopic and endoscopicguidance until the two magnets mate. The magnets are then left in place for 7-14 days to allowtime for a complete magnetic compression anastomosis to occur. During a second endoscopic procedure, the magnets are removed. A large communicationbetween the base of the diverticulum and the esophagus is now visible. Using a diathermicblade, the septum between the diverticulum and the esophagus is progressively cut, thus completingthe diverticulotomy. Results: The first patient had a Zenker s diverticulum unsuccessfully treated with three endoscopicsessions. Then a magnetic compression anastomosis was performed and a partial section of theseptum between the diverticulum and the esophagus was done. One week later, the magnetswere retrieved from the base of the diverticulum and the remaining septum was cut. A bariumswallow performed a month later demonstrated complete passage of barium in the stomach. The second patient had a longstanding history of a large mid-esophageal pulsion diverticulum. During an initial EGD, magnets were successfully placed. 10 days later, the magnets were easilyretrieved and the remaining septum was cut. One month later, the patient presented a completeresolution of symptoms and is still asymptomatic at 5 months.our last patient had a 10-month history of retrosternal discomfort associated with developmentof dysphagia. A barium swallow revealed a large 4 cm deep diverticulum of the loweresophagus. During an initial endoscopic procedure, the magnets were placed. 13 days later,another gastroscopy showed the magnets-induced communication. The magnets were retrievedand the remaining septum was completely cut. One month later, the dysphagia has significantlyimproved. Conclusions: We reported the first series of patients with esophageal diverticula treated bycreation of a magnetic compression anastomosis followed by an endoscopic diverticulotomy. This approach seems promising for the treatment of selected patients with large esophagealdiverticula. Endoscopic view of the final position of the two magnets, with one magnet at the base of the diverticulum and the other at the opposite side of the septum, in the esophagus Ten days following their endoscopic placement, the magnets have joined together and migrated into the diverticulum. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB455
61 Mo1534 Extreme Endoscopy: a New Paradigm in Interventional Endoscopy Monkemuller Klaus*, Paul T. Kroner, Mark C. Phillips, Helmut Neumann, Ivan Jovanovic Basil I. Hirschowitz Endoscopic Center of Excellence, University of Alabama, Birmingham, AL Introduction: Extreme endoscopy is a new discipline in interventional GI endoscopy. Previous data on extreme endoscopy comes from case reports. Aims: To report on the feasibility and outcomes of extreme endoscopy. Methods: Observational, retrospective study conducted at a tertiary care hospital during an 18-months period. All procedures were performed under general anesthesia. Extreme endoscopy comprises five key components: (i) use of multiple scopes or dual endoscope technique; (ii) use of various types of overtubes (OT), (iii) utilization of modified devices, (iv) use of fluoroscopy and, (v) necessity of utilizing a tool box with: wire cutter, glue, tape, foam (Endosponge). Single- or double balloon enteroscopy (SBE, DBE) was not defined as extreme endoscopy, unless the technique was utilized to perform a) endoscopic re-anastomosis of disrupted GI tract; b) PATENT (percutaneous assisted transprosthetic endoscopic therapy); c) SBE- or DBE-rendezvous- ERCP; d) endoluminal stenting, e) removal of migrated SEMS from the small bowel. Additional exclusions: ESD or POEM cases (nz45) and pancreatic necrosectomies (nz28). Success was defined as resolution of the primary luminal problem. Results: 44 patients (23 females, 21 males, mean age 57 years, age range 32-83) with various types of complex primary, secondary or post-surgical anatomy endoluminal GI defects were studied. In 20 patients (45%) previous surgical, endoscopic or radiologic attempts at solving the problem had failed. In 11 patients (25%) there were no other interventional treatment options available. Interventions performed: PATENT (nz3), endoscopic re-anastomosis of the disrupted GI tract (nz4), Endosponge placement for drainage of huge cavities (nz3), OT-assisted removal of mesh (nz2), OT-assisted removal of migrated lap bands (nz3), OT-assisted SEMS placement of the small bowel and/or colon (nz8), combined closure of fistula or perforation and placement of direct endoscopic jejunostomy (nz7), SBE- or DBE ERCP with exchange of scope for slim cholangioscope to perform EHL (nz4), rendezvous-dbe ERCP to place SEMS into the bile duct (nz3) or to place plastic stents percutaneously under direct endoscopic view (nz2), OT-assisted endoscopy allowing for ERCP or PEG placement in patients with esophageal stenosis (nz3). The technical success was 87.8%. The mean procedure time was 35 minutes (range 45 min to 4 hours). There were no major adverse events associated with the procedures. Conclusions: This is the largest study reporting on extreme endoscopy. Albeit time consuming extreme endoscopic interventions lead to a resolution or remediation of complex endoluminal disorders in the majority of patients. It appears that extreme endoscopy may provide hope for patients in whom no other choices exist. Now multi-center studies in this topic are warranted. Diabetes 7 (12.5%) Enterovaginal 3 (5.4%) Immunocompromised 9 (16%) Enterovesical 1 (1.8%) Corticosteroids 3 (5.4%) Anti-Tumor necrosis 2 factor medications (3.6%) Immunomodulators 2 (3.6%) Chemotherapy 5 (8.9%) Radiation 7 (12.5%) NPO 18 (32.1%) Total parenteral 5 nutrition (8.9%) Tube feeding 12 (21.4%) *Mean +/- standard deviation ^Median (Interquartile range) Stent 9 (39.1%) Argon plasma 9 coagulation/heater (39.1%) probes Glue/Fibrin plug 3 (13%) Enteroperitoneal/ enteromediastinal 7 (12.5%) Leak 2 Outcomes (3.6%) Duration of fistula (months)* 8.8 +/- Complications 1 (1.8%) 14.6 Size of fistula (mm)^ 12.5 Immediate success 56 (10, 20) (100%) Etiology of fistula Follow up data available 40 (71%) Post Roux-en-Y gastric bypass 33 Success 17/40 (RYGB) (58.9%) (42.5%) Post-surgery (non-rygb) 10 Failure 23/40 (17.9%) (57.5%) Cancer 5 No follow up 16 (8.9%) (29%) Inflammatory bowel disease 3 Follow up evidence (5.4%) Post percutaneous endoscopic 2 Follow up evidence 18 gastrostomy (3.6%) (45%) Congenital 1 Imaging 13 (1.8%) (32.5%) Infectious 1 Clinical 5 (1.8%) (12.5%) Post pancreatitis 1 Surgery 4 (10%) (1.8%) Previous failed procedures 16 Follow-up (days)^ 130 (65, (28.6%) 251) Type of previous failed procedure Clip 9 (56.2%) Stent 4 (25%) Argon plasma coagulation/ Heater probes 1 (6.25%) Glue/Fibrin plug 1 (6.25%) Surgery 2 (12.5%) Number of previous failed procedure per patient* 2 +/- 1.8 Mo1535 Outcomes of Fistula Closure by Endoscopic Suturing: a Multi- Center Study Saurabh S. Mukewar* 1, Nitin Kumar 2, Marc F. Catalano 3, Christopher C. Thompson 2, Christopher J. Gostout 1 1 Gastroenterology, Mayo Clinic, Rochester, MN; 2 Gastroenterology, Brigham and Women s hospital, Boston, MA; 3 Gastroenterology, GI Health Associates, Milwaukee, WI Background: Endoscopic closure of fistulas is desirable but remains a challenge, especially for gastrogastric fistulas. We report a multicenter experience using endoscopic suturing to close gastrointestinal fistulas. Methods: Electronic records at two academic centers and one private clinic were reviewed to identify patients who underwent sutured fistula closure (OverStitch, Apollo Endosurgery Ò, Inc., Austin, Texas). Demographic, clinical variables and details of endoscopic procedure were recorded. Results: A total of 56 patients underwent single session fistula closure (26: Brigham and Women s hospital; 21: Mayo Clinic and 9: GI associates, Milwaukee, WI). Mean age was 54 +/ years. Gastrogastric fistula (29 (51.8%) was the most common fistula. 16 (28.6%) had a failed previous attempt at closure of fistula. Immediate success was seen in all cases [56 (100%)] and 17 (42.5%) had successful closure of fistulas as observed on endoscopy [18(45%)], imaging [13(32.5%)] or clinical [5(12.5%)] follow up. Gastrogastric fistulas had lower rates of closure [5/19 (26.3%)] compared to other fistulas [12/21 (57.1%)]. Data on subsequent procedures and outcomes was available from Mayo cohort. Out of 21 patients, 2 underwent surgery, 3 had no follow up imaging/endoscopy. 9/15 (60%) required repeat endoscopic procedures (range: 1 to 4) with successful outcome in 4/9 (44.5%) cases. Only one patient (1.8%) had abdominal pain requiring hospital admission. Conclusion: Single session suture closures of fistulas alone are safe and can be effective especially in known challenging cases. Sequential closures for persistent fistula warrants attention. Age* / Male 19 (33.9%) Body mass /- index (kg/m2)* 10.3 Active smoker 8 (14.3%) Type of fistula Gastrogastric 29 (51.8%) Enterocutaneous 10 (17.9%) Enterobronchial 4 (7.1%) Fistula sutures^ 2 (1.5, 4) Additional therapies 23 (41%) Types of additional therapies Clip 10 (43.5%) Mo1536 Management of High Grade Dysplastic in Barrett s Esophagus With Underlying Esophageal Varices William C. Palmer* 1, Milena Di Leo 2, Manol Jovani 3, Michael Heckman 1, Nancy Diehl 1, Prasad G. Iyer 4, Herbert C. Wolfsen 1, Michael Wallace 1 1 Mayo Clinic, Jacksonville, FL; 2 Vita-Salute San Raffaele University, Scientific Institute San Raffaele, Milan, Italy; 3 Humanitas Research Hospital, Rozzano,, Milan, Italy; 4 Mayo Clinic, Rochester, MN Background: Barrett s esophagus (BE) on or adjacent to esophageal varices (EV) is difficult to manage because of increased risk of bleeding. BE predisposes to high grade dysplasia (HGD-BE), which warrants intervention. Aims: To estimate the effectiveness of band-ligation without mucosectomy in EV patients treated for HGD- BE. Resolution was determined based on the presence of either a single normal biopsy, a single non-dysplastic biopsy. Complications including bleeding evaluated. Both outcomes were compared to a reference group of non-ev HGD-BE patients who were treated with multiband endoscopic mucosal resection (EMR) followed by radiofrequency ablation (RFA). Complete resolution of intestinal metaplasia (CRIM) and complete resolution of dysplasia (CRD) were also assessed in EV patients treated for HGD-BE, but only 3 patients had sufficient follow-up to assess these endpoints. Design: Retrospective comparative study. Methods: All 8 HGD-BE patients with EV who were treated with banding at the Mayo Clinic in Jacksonville, FL (NZ6) or Rochester, MN (NZ2) between August, 1999 and February, 2014 were included. In these 8 patients, 34 (4.25 procedure/pt) therapeutic endoscopic procedures were performed. These patients were compared with a reference group of 52 HGD-BE patients without EV who were treated with EMR followed by RFA between September, 2006 and September, 2012 at the Mayo Clinic in Jacksonville, FL. Results: With a median follow-up length of 6.0 months (Range: months), 1 HGD-BE patient with EV (12.5%) experienced a single normal biopsy following treatment, and 3 (37.5%) experienced a single non-dysplastic biopsy. For comparison, with a median follow-up length of 13.0 months (Range: months), 39 EMR-RFA patients (75.0%) experienced a single normal biopsy following treatment, and 49 (94.2%) experienced a single non-dysplastic biopsy. Both of these endpoints occurred significantly more often in the EMR-RFA group compared to the HGD-BE with EV group (log-rank PZ0.016 and PZ0.025, respectively). For the 3 HGD-BE patients with EV who had sufficient follow-up for CRIM/CRD assessment, none experienced CRIM (follow-up lengths of 2.1, 2.3, and 5.9 years), and 1 experienced AB456 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
62 CRD at 2.3 years after the initial banding procedure. None of the 8 esophageal varices banding patients experienced a bleeding complication compared to 7 of the 52 EMR-RFA patients (13.5%), however this difference did not approach statistical significance (PZ0.58). Limitations: Retrospective analysis; small number of patients; limited follow up. Conclusions: HGD-BE can be safely managed with EBL, with diligent monitoring for post-procedure hemostasis however resolution of dysplasia and Barrett s epithelium is rarely achieved with banding alone. Further study is needed to assess safety of multiband mucosectomy and RFA after completion of EVL eradication. Mo1537 Endoscopic Suturing System for Fully Covered Metal Stent Fixation: Initial Experience in a Safety Net Population Ali Fakhreddine*, Anuj Datta, Douglas Hunt, Disaya Chavalitdhamrong, Viktor E. Eysselein, Sofiya Reicher Gastroenterology, Harbor-UCLA Medical Center, Torrance, CA Background & Aims: In a safety net population, both benign and malignant diseases tend to be diagnosed at advanced stage due to late presentation for medical care. Fully covered metal stents (FCMS) are increasingly applied to treat and/or palliate severe luminal narrowing in the upper GI tract; however, stent migration is a common complication. The Overstich endoscopic suturing system (Apollo Endosurgery, Austin, TX) has been used for FCMS fixation in the past few years, but the overall published experience is limited. We aimed to evaluate the use of endoscopic suturing system for FCMS fixation in a safety net population. Methods: A prospectively maintained database of patients with endoscopic suturing, initiated in May 2014 at our institution, was evaluated for patient demographics, procedure indication, stent and suture type, 30-day stent migration and complication rates. Two or three 2-0 polypropylene sutures were placed for FCMS fixation of the stent s proximal end. Results: 11 endoscopic suturing FCMS fixation procedures were performed in nine patients (8 male/1 female, years old). In one patient, in addition to stent fixation, endoscopic suturing was used for gastrocutaneous fistula closure. In seven patients, stents were placed in the esophagus (5 for benign refractory strictures, 2 for malignant). In two patients, stents were placed across a severely strictured gastrojejunal anastomosis. Prior to stent placement, the patients with benign esophageal strictures had stricture diameter of 6-8 mm despite repeated (6.7 on average) balloon dilations. Most of the sutured stents were biliary FCMS (Viabil Gore), due to restrictively small stricture diameter. Four esophageal FCMS were placed (1 Wallflex Boston Scientific and 3 Evolution Cook Medical). All suture placements were technically successful and without peri-procedural complications. One esophageal FCMS and one biliary FCMS migrated at 8 weeks after placement; three patients are currently pending stent removal. Conclusion: Endoscopic suturing is a useful adjunct to stenting, especially in patients with severe luminal narrowing due to late stage presentation. Endoscopic image of gloved finger through gastrocutaneous fistula Stent fixation across strictured GJ anastomosis and gastrocutaneous fistula closure Mo1538 High Success Rate for Over-the-Scope Clip (OTSC) System in the Acute Management of GI Tract Perforations: a Single Center Experience Chien-Lin Chen*, Matthew A. Chin, Kenneth J. Chang, John G. Lee, Jason B. Samarasena Gastroenterology, University of California - Irvine, Orange, CA Background: Effective endoscopic management of gastrointestinal defects remains one of the major challenges of current endoscopy. A novel over-the-scope-clip (OTSC) system has been recently introduced for treatment of perforations and fistulas. The objective of this study was to evaluate our experience of the OTSC system in the treatment of perforations and fistulas. Methods: This was an observational, retrospective case series of consecutive patients who underwent OTSC treatment of perforation and fistula at a single tertiary care center. Technical success was defined as adequate deployment of the OTSC on the target lesion with or without confirmation of repair with immediate contrast study. Clinical success was defined as resolution and healing of the underlying GI defect attributed to the OTSC, as evidenced by clinical, endoscopic, and/or abdominal imaging, with a minimum of 2 weeks of follow up. Results: A total of 23 OTSC applications were used in 17 patients. The median age was 65 (range 24-89), and median follow up was 60 days. Overall technical success rate was 94% (16 out of 17). For perforation repair, technical success rate was 91% (10 out of 11), and clinical success rate was 90% (9 out of 10). Perforation location included stomach (n Z 2), duodenum (n Z 4), jejunum (n Z 1), and colon (n Z 4). Seven perforations were related to endoscopic mucosal resection (EMR). All but one patient underwent perforation repair the same day, with 8 of those performed immediately during the same endoscopy. The grasping device was used for approximation of defect edges in 8 cases. For fistula repair, technical success rate was 100% (6 out of 6). Overall clinical success rate was 50% (3 out of 6), and was higher when OTSC was used for primary fistula repair (2 out of 3), compared to rescue therapy (1 out of 3). Prior failed therapies included two patients treated with esophageal stents, and one patient treated with surgical debridement. Concomitant endoscopic argon plasma coagulation (APC) therapy of fistula tract was used with OTSC in three cases. Fistula types included gastrocutaneous (nz 3), gastric-peritoneal (n Z 1), gastric-hepatic (n Z 1) and tracheoesophageal (nz 1). There were no adverse events or complications related to deployment and application of the clipping device. Conclusion: This single center experience shows that the OTSC system was a safe and highly effective therapy for repair of acute GI perforations. The clinical success of OTSC for fistula repair was lower but appeared to be more effective when used for primary therapy as opposed to rescue therapy. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB457
63 Abstracts Mo1539 Endoscopic Submucosal Dissection Using Alternant Clipping Technique in Gastric Antrum Lesions Yun Wang*1, Lijuan Qian2, Lin Lin1, Hongjie Zhang1, Yinghong Xu1, Li Chen1, Ruihua Shi1 1 Gastroenterology, The First Affiliated Hospital of Nangjing Medical University, Nanjing, China; 2GI, The First Affiliated Hospital of Suzhou Universtiy, Suzhou, China Background and Study Aims: Endoscopic submucosal dissection (ESD) is accepted as minimally invasive treatment for gastric dysplastic lesions. The mucosa and submucosa in gastric antrum is much thicker than that in fundus and corpus, thus it is difficult to close the artificial ulcer in antrum in traditional clipping way. We report on a novel alternant clipping technique which facilitates the closure of the antrum post-esd ulcer surface. The aim of this study was to evaluate the feasibility, efficacy of the alternant clipping technique in antrum ESD. Patients and Methods: Data for all patients who underwent antrum ESD in our hospital between January 2012 and December 2013 were analyzed retrospectively. Clinicopathological characteristics the mean ESD procedure time, postoperative hospitalization length and the operation complications in patients with alternant clipping treatment were compared with controls who underwent no clipping treatment. All the patients were followed up. Results: Seventy patients underwent antrum lesion ESD with alternant clipping technique and 32 patients without clip treatment after ESD procedure. There were no significant differences of the mean age, gender constituent ratio and lesion size, both length and width, between the two groups. There was no significant difference in procedure time, but postoperative hospitalization was shorter in alternant clipping treatment group. Bleeding complication incidence was lower in patients with alternant clipping technique. All the patients were followed for more than 6 months (range 1-7 months in without clip treatment group and 1-11 months in with alternant clipping treatment group). Both groups showed similar rate of ulcer healing at 1 month after ESD operation, and there was 11 out of 70 patients had clips residue. Conclusions: Alternant clipping technique is easy to perform and facilitates complete closure of antrum post-esd ulcer surface, enabling a safe and low complication risk operation to be performed. This technique is potentially applicable to other gastrointestinal regions. A) Anterior duodenal perforation related to endoscope trauma. B) Successful OTSC deployment and closure of perforation. C) Follow up endoscopy at 6 weeks showed healed mucosa with intact clip (arrow) Mo1540 EndoclotTM Polysaccharide HEMOstatic System to Reduce Delayed Bleeding Following Upper and Lower Gastrointestinal Resection Preliminary Results of the Hemostop Study Fergus Chedgy*, Rupam Bhattacharyya, Kesavan Kandiah, Mohammed Nizamuddin, Gaius R. Longcroft-Wheaton, Fergus Thursby-Pelham, Pradeep Bhandari Endoscopy, Queen Alexandra Hospital, Portsmouth, Portsmouth, United Kingdom Background: Endoscopic resection of advanced neoplasia in the upper and lower gastrointestinal tract is now possible with the techniques of endoscopic AB458 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
64 submucosal dissection (ESD) and endoscopic mucosal resection (EMR). However, these techniques create large mucosal defects, subsequently increasing the risk of significant post-procedural bleeding which may have catastrophic consequences. Endoclot TM is a topical hemostatic powder that rapidly absorbs water creating a high concentration of platelets, red blood cells and clotting factors - accelerating the natural coagulation cascade. Routine application of Endoclot TM to ESD or EMR defects is hypothesised to reduce the risk of significant post EMR/ESD bleeding. Patients and Methods: 496 patients underwent lower gastrointestinal EMR/ESD at our institution between 2005 and 2013 with a mean polyp size of 43mm and 12% with scarring. Significant delayed bleeding was seen in 21 of 496 patients (4%). 264 patients underwent upper gastrointestinal EMR/ESD at our institution between 2005 and Significant delayed bleeding was seen in 9 of 264 patients (3%).Prophylactic use of Endoclot TM, following endoscopic resection of large lesions, to prevent delayed bleeding was introduced in June To date, 26 patients have undergone colonic EMR/ESD (mean polyp size 44mm, 46% scarred) and 19 patients have undergone upper gastrointestinal resection. There was 1 significant delayed bleed in the colonic group (3%) requiring further endoscopic therapy. Subsequent inspection of the ESD base revealed dislodgement of 2 endoclips. This patient also had inadequate coverage (30%) of Endoclot TM due to device clogging, experienced early in the use of Endoclot TM. There was 1 bleed in the upper GI group, which occurred following ESD at the gastroesophageal junction. This was managed with further endoscopic therapy without the need for blood transfusion. There have been no complications related to Endoclot TM use. Conclusions: Endoclot TM shows promise in reducing the risks of delayed bleeding following endoscopic resection of neoplastic lesions from the gastrointestinal tract. Although our study group is small, we have demonstrated a 1% reduction in risk of delayed bleeding following EMR/ESD for large colonic polyps in a group with a significantly higher rate of scarring and therefore bleeding risk. A randomised controlled trial is required to clarify the role of routine use of Endoclot TM following EMR/ESD. Mo1541 Results of 700 Cases of Intragastric Balloon Leonardo S. Almeida* Bariatric Endoscopy, IMO - Instituto Mineiro de Obesidade, Belo Horizonte, Brazil This work shows the results obtained with 700 cases of patients treated with intragastric balloon and its accompanying one year after removal of the balloon.the objective is to demonstrate the results obtained with treatment with intragastric balloon, its relationship with the quality of multidisciplinary monitoring and importance of the permanence of monitoring after the removal of intragastric balloon.700 cases of which cases of early intolerance were excluded. The retrospective study was based on records from the Institute records. From a total of 500 patients had a ratio of weight loss relative to the initial total weight of the Patient:3.74% of the patient from 0 to 5%13.79% of patients in 5 to 10%31.57% of patients of 10 to 15%26.8% of patients 15 to 20%24.1 of patients above 20%Of the patients only 296 are over 1 year of removal of the balloon and these 296 patients were divided into two groups, a first group that continued multidisciplinary monitoring, as advocated in our service for 1 month for each Kilo lost weight, and a second group abandoned the multidisciplinary monitoring after removal of intragastric balloon. The result in the multidisciplinary group of up was 98% of patients with stable weight and only 2% of patients regained weight. In the group of patients who dropped out multidisciplinary treatment after the removal of the intragastric balloon 68% of patients had regained weight versus only 32% of patients remained stabilized. Conclusion: The intragastric balloon can get very good results, however it depends on a good multidisciplinary support program focused on changing habits of the patient, involving a team psychologist, nutritionist and physical trainer. These should use the therapeutic window created by the weight loss provided by the balloon to create a platform of support for the six months that the patient is with the balloon and maintaining this support platform after balloon withdrawal is essential to obtain core durable results, the use of staff actively seeks to avoid abandonment of the treatment by patients is highly recommended. Mo1542 Utilization of the Endoscopic Suturing (ES) Technology in a Tertiary Care Setting Atul Khanna*, Sami A. Almaskeen, Laith H. Jamil, Kapil Gupta, Simon K. Lo Gastroenterology - Interventional Endoscopy, Cedars-Sinai Medical Center, Los Angeles, CA After years of development, ES has finally become a clinical reality. It has far-reaching implication and is potentially a highly valuable disruptive innovation. It is technically challenging to apply and is rather costly, limiting its current use in mostly tertiary care environments. Aim: examine how ES is applied in the clinical setting. Methods: All ES procedures done in our institution were included. Chart reviews were done retrospectively. Results: Over a 12 month period, 34 patients had undergone 54 ES procedures for 61 indications: 7 (11.4%) in direct attempts to close acute perforations, 17 (27.8%) for suture closure of chronic fistulae, and 37 (60.6%) for anchoring of gastrointestinal metal stents, which were done for stent closure of wall defects or high grade benign strictures. Majority of stent anchoring was in the esophagus (nz33), and direct ES intervention for fistula closure was done mostly in the stomach (nz13). Prior to performing ES, 65 interventions had been tried on 27 (79%) patients, representing 2.4 procedures per patient. ES was considered technically successful in 47 of 54 (87%) procedures. There were 2 failures (2/54Z 3.7%), with one due to technical limitation and another from device malfunction. Additional 4 cases were deemed to be done suboptimally. One complication was encountered during the procedure: esophageal perforation that resulted in surgical repair. There was no mortality related to ES. The total number of stitches deployed was 147, with the average of 2.5 stitches done for each procedural indication. Thus far, 38 follow up examinations had been carried out. ES was considered therapeutically successful (intact anchoring, fistula closed, etc.) in 15 cases, while partially effective in 8. However, 15 cases were deemed to be ES treatment failures. 12 of these failures were done for primary closures. Conclusions: In our center, ES is typically utilized for cases that have already failed other interventional attempts. Even though it is originally intended for closure of gastrointestinal wall defects, we have found more common usage of ES for anchoring of fully covered metal stents. Whether it is due to our lack of technical expertise, we have failed to close most acute leaks or chronic fistulae with ES alone. Further experience is needed to confirm this observation. Indications for ES Direct Intervention Stent anchoring Acute leak Chronic fistula (O4monhts) Esophagus Stomach Duodenum Colon Total (60.6%) 7 (11.4%) 17 (27.8%) Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB459
65 Mo1543 Preliminary Results of a New Method for Endoscopic Submucosal Dissection and Ablation Therapy Using Two Types of LASER System Joo Young Cho* 2, Weon-Jin Ko 2, Jun Hwan Yoo 2, Duk Hwan Kim 2, Suk Pyo Shin 2, Ga Won Song 2, Wonhee Kim 2, Kwang Hyun Ko 2, Ki Baik Hahm 2, Sung-Pyo Hong 2, Pil Won Park 2, Jun-Hyung Cho 1 1 Digestive Disease Center, Soonchunhyang University Hospital, Seoul, Korea (the Republic of); 2 Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam-si, Korea (the Republic of) Background/Aims: During the era of therapeutic gastrointestinal endoscopy, this study aims to evaluate thefeasibility of novel laser systems when performing treatment of gastric epithelial neoplasia. Methods: A total of 24 patients were enrolled into this study. 18 patients were diagnosed as gastric adenoma (n Z 7) or adenocarcinoma (n Z 11) and underwent endoscopic submucosal dissection (ESD) by a single expert endoscopist. Thulium or diode laser system were used for all ESD procedures including marking, mucosal incision and submucosal dissection. Instead of endoscopic knives, a flexible silica fiber was inserted through the working channel of the endoscope. The remaining 6 patients underwent ablation therapy due to pathologic result of lateral margin positivity after previous ESD. Results: In 18 patients, ESD was completed using thulium or diode laser without the need to change other endoscopic knives. The median time for total procedure was 49 minutes (range, minutes). In 16 of 18 patients, active bleeding was not observed during ESD. Curative resection was achieved in 83.3% (n Z 15/18) of patients. Also, all patients underwent ablation therapy using these lasers did not show local recurrence during follow-up period. There were no significant complications, such as delayed bleeding and perforation. Conclusions: These laser systems are feasible in endoscopic management of gastric epithelial neoplasia. Mo1544 Endoscopic Surgery With the Dental Floss Traction for Upper Gastrointestinal Submucosal Tumors Yun-Shi Zhong*, Qiang Shi, Li-Qing Yao Endoscopy Center, Zhongshan Hospital, Fudan University, Shanghai, , China, Shanghai, China Background: Endoscopic surgery, which was developed from endoscopic submucosal dissection (ESD) techniques, has been used to remove submucosal tumors, particularly tumors that originate from the muscularis propria of the digestive tract. When ESD is used for large mucosal lesions of the upper gastrointestinal tract, endoscopists commonly have difficulty maintaining direct visualization of the submucosal dissection layer. In response to this issue,a simple technique that uses a pulley method (dental floss traction) was developed to facilitate ESD procedures during the excision of large early stage gastric cancers. This aim of this study was to identify the potential usefulness of the endoscopic surgery using dental floss traction for upper gastrointestinal submucosal tumors (SMT). Methods: This was a retrospective study performed at a single institution. Between June and August of 2014, 8 consecutive patients presenting with upper gastrointestinal SMTs at Zhongshan Hospital, Fudan University were enrolled in the study. During the stripping process of the ESE or STER, it became increasing difficult to expose the tumor boundary, due to the large size of the tumor. After removing the endoscope, an endoloop (MAJ-339; Olympus, Tokyo, Japan) was tied on the tip of the dental floss, while the shorter side of the floss was cut to prevent it from affecting the field of view. The longer side of the floss was attached to the endoscope body side and was guided by an assistant. The endoscope was then reinserted, and the tumor was trapped by the endoloop. When the assistant pulled the dental floss, the tumor edge became clearly exposed. The tumor was then peeled away under direct visualization. Finally, the lesion was resected completely from the muscularis propria layer using the electric knife. The tumor characteristics, en bloc resection rate, and the treatment regimen were evaluated for all patients. Results: Of the 8 patients treated with endoscopic surgery with the dental floss traction, three had lesions located in the lower esophagus and were given submucosal tunneling endoscopic resection (STER) with the traction, while five had lesions located in the stomach and were given Endoscopic submucosal excavation (ESE). Pathological examination determined that the five stomach lesions were gastrointestinal stromal tumors (GISTs), while the three esophageal lesions were leiomyomas. All resected tumors were removed completely without interruption of the tumor capsule. Conclusions: The dental floss traction method appears to be useful in the ESE and STER procedures. The ESD process Mo1545 Laparoscopic Endoscopic Cooperative Surgery for Gastric and Duodenal Adenocarcinoma Yuichi Waragai* 1, Takuto Hikichi 2, Ko Watanabe 2, Jun Nakamura 1, Hitomi Kikuchi 1, Tadayuki Takagi 1, Rei Suzuki 1, Mitsuru Sugimoto 1, Naoki Konno 1, Hiroyuki Asama 1, Mika Takasumi 1, Masaki Sato 1, Katsutoshi Obara 2, Hiromasa Ohira 1 1 Department of Gastroenterology and Rheumatology, Fukushima Medical Universi, Fukushima, Japan; 2 Endoscopy, Fukushima Medical University Hospital, Fukushima, Japan Objective: Endoscopic resection (ER), such as endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) for cancer of the gastric fundus and duodenum, entails high risk of perioperative and postoperative perforation and bleeding. This study evaluated the usability and safety of laparoscopic endoscopic cooperative surgery (LECS) for them. Methods: During July 2013 through September 2014, we treated two gastric cancers located in the fundus and two duodenal tumors (1 carcinoma, 1 adenoma). Under general anesthesia, ER was done using laparoscopic intervention. After ER, the resected site was reinforced laparoscopically. For LECS, perioperative and postoperative complications and outcomes were evaluated. Results: For two cases of gastric cancers, we conducted ER by endoscopic ESD. In each case, the histological type was tub 1; the invasion depth was M. The respective tumor diameters were 28 mm and 24 mm. The resected specimen diameters were 55 mm and 47 mm, respectively. Neither showed intraoperative perforation or postoperative perforation or bleeding. In one case, extragastric developing GIST was found right under the tumor during the operation, so full-thickness excision was conducted on the GIST after ESD. The ESD was not in left lateral decubitus position but in the spine position. Therefore, we had a more difficult time manipulating the scope than we usually did. However, the position reassured us that if intraoperative perforation occurred, we would be able to reef it quickly. Follow-up durations were 9 months and 15 months, respectively. Neither case showed recurrence. Two cases of duodenal tumors were 5 mm in-situ adenocarcinoma and 4 mm adenoma, both of which were located in the descending part, and which were able to be resected en bloc using EMR. The resected diameters were, respectively, 16 mm and 25 mm. Neither showed intraoperative perforation or postoperative perforation or bleeding, too. However, because the mesentery around the duodenum was removed from the side of the laparoscope, manipulating the endoscope was difficult. The follow-up durations were 18 months and 22 months, respectively. Neither case showed recurrence. Conclusion: By performing LECS for treatment laparoscopically, we were able to provide sure and safe treatment for the gastric cardia and duodenal tumors, which otherwise would have entailed high risks of intraoperative and postoperative complication in ER. However, because the position differs from that for usual ER, endoscope manipulation sometimes becomes difficult. Therefore, it is necessary to devise better methods by examining many cases. Mo1546 Novel Fully Covered, Self-Expanding Metal Esophageal Stent (Niti-S) in the Post Sleeve Leak and Fistula Abed H. Al-Lehibi*, Khalid Alsayari Gastroenterology, king Faghad Medical City / Kind Saud Bin Abdulaziz Univeersity, Riyadh, Saudi Arabia Background: Laparoscopic sleeve gastrectomy (LSG), although generally effective and safe, can be associated with some complications such as staple-line leaks and fistulas and therefore significant morbidity. The use of esophageal stents has been used in managing leaks but migration of these stents occurred commonly. A novel fully-covered, self-expanding metal stent (Niti-S), specifically designed for post-lsg leak treatment, has been recently introduced. To date, only one case series of 4 patients with post LSG leaks has been published. Objective: To describe the second and larger case series of patients with a staple-line leak after LSG who were AB460 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
66 endoscopically managed with this stent. Design: Case seriessetting: One large academic referral center. Patients: A total of 5 patients with a staple-line leak after LSG Interventions. A novel fully-covered, self-expanding endoscopically deployed metal stent ( Niti-S from, Korea) Main Outcome Measurements:Complete leak repair and fistula closure. Results: A total of 5 patient of post sleeve gastrectomy leak and one patient with gastrobronchial fistula underwent endoscopic stenting with Niti- S fully covered long stents. The average age was 36 years and the average BMI was 42, male was 80% of patients were and female were 20%. The median time of stent was 4 days. The average duration of stent placement was 7 weeks. The Successful treatment of gastric leak was in 5 patients (100 %) patients, as confirmed by gastrografin swallow 2-3 days after stent removal. There was no significant different between the time of the surgery and stent placement in team of higher success rate of leak seal. A complete leak repair was achieved in all 5 patients and complete fistula closured. No stent migration occurred. No recurrent leak occurred in any patients.limitation:- Single center and small series. Conclusions: A case series suggests that patients with post-lsg staple-line leaks may be safely and effectively managed with the endoscopic placement of a novel FC-SEMS ( Niti-S) Mo1547 Evaluation of the Optimal Concentration of Sodium Hyaluronate in Precutting EMR for Various Organs in a Porcine Model Yuta Nakagawa*, Kenshi Matsumoto, Akihito Nagahara, Ippei Tanaka, Yoichi Akazawa, Tsutomu Takeda, Kohei Matsumoto, Hiroya Ueyama, Yuji Shimada, Daisuke Asaoka, Mariko Hojo, Sumio Watanabe Gastroenterology, Juntendo University, Bunkyo city, Japan Background and Study Aims: A solution of 0.4% sodium hyaluronate (SH) is often used to obtain sufficient mucosal elevation height (MEH) in precutting endoscopic mucosal resection (PEMR), but the concentration of SH should be as low as possible to avoid the risks associated with its use. This study used resected porcine organs as models to estimate the minimal SH concentration that is required to maintain adequate MEH during PEMR in the oesophagus, stomach, duodenum and colon. Methods: Three endoscopists independently performed circumferential incision (CI) in 10 resected porcine oesophagi, stomachs, duodenums, and colons. Three different solutions were injected into submucosae after CI: A, normal saline (NS); B, NS plus 0.4% SH mixture at a 1:1 ratio; and C, 0.4% SH. The MEH increases over time were measured precisely, and the success of snaring after injection was recorded. Results: The initial MEH did not exhibit a significant difference among the solutions in those organs without a duodenum. No solution obtained MEH in the duodenum. The ability of lesion-lift was superior at higher SH concentrations. The lesions in the oesophagus were snared only by Solutions B and C. All solutions snared the lesions in the stomach. Only Solution C snared the lesions in the colon. The safety of PEMR using these solutions was confirmed histopathologically. Conclusions: The optimal injection solution for PEMR was Solution B in the oesophagus, Solution A in the stomach, and Solution C in the colon. The application of PEMR to human duodenums should be carefully considered. Mo1548 Safety and Efficacy of a Through-the-Scope Esophageal Stent for Non- Sophageal Indications: a Single Center Case Series Sepideh Besharati*, Saowanee Ngamruengphong, Vivek Kumbhari, Ahmed Abdelgelil, Mohamad H. El Zein, Alan H. Tieu, Patrick I. Okolo, Anthony N. Kalloo, Mouen Khashab Johns Hopkins Medical Institute, Baltimore, MD Background: One commercially available through-the-scope esophageal self-expandable metallic stent (TTS-SEMS) (Niti-S, TaeWoong Medical, Seoul, Korea) has been used for various esophageal indications, such as benign and malignant strictures, leaks/fistulae and perforations. Because of their simple TTS deployment under direct endoscopic visualization, these stents have been utilized for non-esophageal luminal gastrointestinal (GI) conditions; however, data on safety and efficacy of this practice is scarce. Aim: To investigate the safety and efficacy of these stents fornon-esophageal GI indications. Methods: This was a retrospective single center study. All consecutive patients who underwent esophageal TTS-SEMS deployment for treatment of benign (stricture, leak, fistula and perforation) and malignant indications between 8/2012 and 9/2014 at one US tertiary academic center were reviewed. Outcome variables were technical success (correct stent placement at the intended location), clinical success (resolution of underlying pathology), and adverse events. Adverse events were graded according to the ASGE lexicon criteria. Results: A total of 24 patients (mean years; 14 female) underwent 43 stenting procedures (35 fully covered and 8 partially covered) using the esophageal TTS- SEMS during the study period. Of these, 22 patients underwent stenting for benign indications (17 strictures, 2 leaks, 2 fistulae and 1 perforation) and 2 patients had malignant strictures. Technical success was 100%. Most common stent location was at the gastrojejunal anastomosis (nz9, 38%) followed by duodenum (nz7, 29%), colon (nz5, 21%), jejunum (nz2, 8%), and ileum (nz1, 4%). Stent fixation was performed in 2 patients, one using an over-the-scope clip in the duodenum and 1 using endoscopic suturing in the jejunum. Clinical response rate was 54 % (nz13) during a median follow-up of 123 days ( days). Patients with strictures were more likely to have clinical failure than those with leaks/fistulae/perforations (71% vs. 10%, pz0.003). A total of 19 patients (79%) developed 33 stent-related complications, which included stent migration (76%), obstruction (12%), bleeding (9%) and chest pain (3%). Complications were graded as moderate in 17 (52%) and mild in 16 (48%). There was no stentrelated mortality. Conclusions: Esophageal TTS-SEMSs are moderately effective for luminal extra-esophageal indications. This practice is also associated with a high rate of stent-related complication, most commonly stent migration. TTS stents designed for usage in the small bowel and colon are needed for optimal safety and efficacy. Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB461
67 Mo1549 Meta-Analysis of the Orbera Intragastric Balloon for the Endoscopic Management of Obesity Badr Al-Bawardy* 1, Saurabh S. Mukewar 1, Alfred Genco 2, Manoel P. Galvao Neto 3, Gontrand Lopez-Nava 4, Nitin Kumar 5, Christopher C. Thompson 5, Erik B. Wilson 6, Sohail Shaikh 5, Natan Zundel 7, Christopher J. Gostout 1, Barham K. Abu Dayyeh 1 1 Mayo Clinic, Rochester, MN; 2 Sapienza University of Rome, Rome, Italy; 3 Gastro Obesity Center, São Paulo, Brazil; 4 Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, Madrid, Spain; 5 Brigham and Women s Hosptial, Boston, MA; 6 Univesrity of Texas, Houston, TX; 7 FIU Herbert Wertheim College of Medicine, Miami, FL Background and Aims: The Orbera Intragastric Balloon (IGB) System has been widely used outside the United States (US) as an effective adjunct to life-style modification in the management of mild to moderate obesity. We performed a systematic review and meta-analysis to summarize the out of the US safety and efficacy experience with this IGB system in anticipation of its possible use in the US after regulatory approval. Methods: A comprehensive search of Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, Scopus, and Web of Science was conducted. The search strategy was designed and conducted by an experienced librarian with input from the study s team. Two independent reviewers reviewed all citation and identify full-length clinical studies, published in English, investigating use of the Orbera IGB system for obesity. A random-effect meta-analysis and meta-regression were performed. Results: Eighty studies including 8506 patients were included in this meta-analysis. The pooled percent total body weight (%TBW) lost after a single six-months IGB insertion was 12.7% [95% CI ], 13% [95% CI ], 10 [95% CI ], and 6.2 [95% CI ] at 3, 6, 12, and 36 months respectively. The pooled incidences of side-effects were as following: pain 33.7%, nausea 29%, GERD 18.5%, early removal 7.5%, gastric ulcers 2%, migration 1.4%, small bowel obstruction 0.3%, perforation 0.1%, and death 0.08%. Five included studies were randomized controlled trials (RCTs) that compared the Orbera IGB system to sham or life-style interventions. The mean extra weight lost after Orbera over that in the control arm at 6 months was -8.5kg [95% CI ] (p!0.001). Three different RCTs evaluated the efficacy sequential use of the Orbera IGB system compared to single use. The mean decrease in body mass index (BMI) after two sequential treatments with Orbera IGB was -4 [95% CI ] (pz 0.047) over that seen with single treatment at 12 months after insertion. A meta-regression showed that higher IGB fill volumes are associated with greater weight loss at six months (p % 0.001) (figure). A funnel plot did not reveal any evidence of publication bias. Conclusions: The Orbera IGB system seems to produce predictable and significant weight loss with a favorable safety profile that should make it a valuable tool for the management of obesity once approved for use in the United States. Mo1550 Multicenter Prospective Study About Histological Diagnosis of Gastric Cancer by White Light and NBI Magnified Endoscopy With and Without Acetic Acid Takaaki Kishino* 1, Tsuneo Oyama 2, Eiji Ishii 3, Manabu Takeuchi 4, Tokuma Tanuma 5, Kotaro Shibagaki 6, Tadashi Miike 7, Keita Funakawa 8, Yoko Kitamura 9, Tetsuro Yamazato 10, Yasuharu Kuwayama 11 1 Gastroenterology, Saku Central Hospital Advanced Care Center, Saku, Japan; 2 Endoscopy, Saku Central Hospital Advanced Care Center, Saku, Japan; 3 Gastroenterology, Kameda Medical Center, Kamogawa, Japan; 4 Gastroenterology, Niigata University Medical and Dental Hospital, Niigata, Japan; 5 Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan; 6 Gastroenterology, Tottori Municipal Hospital, Tottori, Japan; 7 Gastroenterology, University of Miyazaki, Miyazaki, Japan; 8 Digestive Disease and Life-style Related Disease, Kagoshima University School of Medical and Dental Sciences, Kagoshima, Japan; 9 Gastroenterology, Nara city hospital, Nara, Japan; 10 Gastroenterology, Tokyo Metropolitan Cancer Detection Center, Hutyu, Japan; 11 Gastroenterology, Tokushima Red Cross Hospital, Komatsushima, Japan Background: The usefulness of NBI magnified endoscopy (NBI-ME) in diagnosing histological type (HT) of gastric cancer (GC) is unclear. Objective: The aim of this study is to evaluate the diagnostic accuracy for HT of GC by white light endoscopy (WL), NBI-ME and NBI-ME with acetic acid (NBI-AA). Design: Multicenter prospective study (UMIN ) Materials: Depressed-type GCs resected by ESD from Aug to Jul in 10 institutes were prospectively enrolled in the study. 221 cases were analyzed whose point by point cross-evaluation of ME and histology was possible. Methods: Endoscopic diagnosis: A 3mm area in oral edge of the lesion was selected as a target area (TA) to diagnose HT. Two marks were placed between the TA to compare endoscopic and histological findings. At first, the HT of TA was diagnosed by WL, followed by NBI-ME and NBI-AA. The HT was classified into well (wel), moderately (mod) and poorly (poor) differentiated type. In WL, homogeneous red or whitish lesions, strong or spotted red lesions and undemarcated whitish lesions were diagnosed as wel, mod and poor, respectively. NBI-ME findings were classified based on vascular and surface patterns. Vascular pattern was diagnosed based on vascular networks (NW) and irregularity. If NW was present, HT was diagnosed as wel. If NW was absent, it was diagnosed based on vascular irregularity. Surface patterns were grouped into pit, villous and unclear pattern. When pit pattern was identified, HT was diagnosed as wel or mod based on irregularity. Villous pattern was subgrouped into villi, micro-villi and fusioned villi. Villi and micro-villi was diagnosed as wel and mod, respectively. In case of fusioned villi and unclear pattern, HT was diagnosed based on vascular irregularity. In NBI-AA, HT was diagnosed based on surface patterns alone. When the surface pattern was unclear, it was diagnosed as poor. Pathological diagnosis: An expert pathologist diagnosed the HT of TA. Result: Histological types of target areas were wel, mod and poor in 166, 40 and 15 cases, respectively. The sensitivity of wel, mod and poor by WL, NBI-ME and NBI-AA were 99.4% (165/166), 89.6% (149/166) and 94.6% (157/166) in wel, 0% (0/ 40), 20% (8/40) and 12.5% (5/40) in mod and 60% (9/15), 60% (9/15) and 60% (9/15) in poor, respectively. There were no significant differences. Sub-analysis: The diagnostic accuracy by surface pattern in NBI-ME was 100% (20/20) in pit pattern, 78.9% (120/152) in villous pattern and 53.1% (26/49) in unclear pattern. And NBI-AA changed these diagnostic accuracy 100% (20/20), 78.3% (119/152) and 65.3% (32/49) respectively. While the diagnostic accuracy by unclear pattern in NBI-ME was low compared to other surface patterns, NBI-AA improved it from 53.1% to 65.3%. Conclusion: NBI-AA is useful for histological diagnosis of gastric cancers when surface pattern is unclear in NBI-ME. Mo1551 Use of Optical Coherence Tomography (OCT) in the Evaluation of Gastric Lesions Ming-Ming Xu*, Stephen M. Lagana, Amrita Sethi Gastroenterology, Columbia University, New York City, NY Background & Aims: Optical coherence tomography (OCT) is a light-based imaging modality that allows high resolution, microscopic level cross-sectional imaging of the mucosa of the gastrointestinal tract during endoscopy (Huang 1991). It has been described in the evaluation of Barrett s esophagus and colonic polyps for identifying areas of dysplasia in-vivo during endoscopy (Das 2001, Pfau 2003). To date however, there have been no studies describing the imaging characteristics of OCT in the stomach. The aim of this study was to describe OCT findings when imaging a range of gastric mucosal lesions and correlate these images with histopathology. Method: Between July 2014 to October 2014 patients referred for endoscopic submucosal dissection (ESD) for a suspicious appearing gastric lesion or prior biopsy showing LGD underwent volumetric laser endomicroscopy (Nvision VLE imaging system, Nine Point Medical) imaging of the stomach during their endoscopy. The Nvision VLE system is a commercially available OCT device with an axial resolution of 7mm and image depth of 3mm. VLE images of the gastric lesion(s) were retrospectively paired with the histopathology of each resected specimens to correlate VLE findings with the associated histology ranging from gastric mucosa with intestinal metaplasia AB462 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
68 (IM), low grade dysplasia (LGD), high grade dysplasia (HGD), to submucosal tumor. Results: Five patients underwent OCT imaging with the VLE system using a 20mm balloon. All exams were technically successful. A total of 80 VLE-biopsy paired images were retrospectively reviewed by the investigators and a GI pathologist. Patient demographics, endoscopic and endosonographic findings, VLE findings, and histopathology are detailed in Table 1. The following types of lesions were visualized: normal gastric mucosal with focal IM, LGD, HGD and neuroendocrine tumor. VLE images of normal gastric epithelium demonstrates alternating areas of high and lower reflectivity (or scattering) resulting in a stippled appearance of the mucosal surface with pit and crypt architecture. Both LGD and HGD results in a loss of pit and crypt architecture, higher surface reflectivity (due to increased nuclear to cytoplasmic ratio in dysplastic tissue) and heterogeneous appearence of the mucosal layer. In the presence of submucosal tumor, the dense tumor infiltration is seen on VLE as high depth penetration with more defined layering differentiating the mucosal and submucosal layers. Conclusion: OCT images of the stomach are distinctive and notably different from the well-defined architecture of the esophagus. This small series demonstrates circumferential OCT imaging is feasible in the stomach and may have a role in the evaluation of suspicious gastric lesions. Further study is needed to determine findings that may be more specific to differentiating degrees of dysplasia and carcinoma. Table 1. Characteristics of gastric lesions evaluated by VLE Case No Age Sex Abdominal symptoms Endoscopic findings 1 69 F Diarrhea Nodularity, erythema in antrum 2 69 F Pain Gastric antral ulcer 3 67 F Pain, bloating Mass with oozing, ulceration on greater curvature 4 68 F Pain Two ulcerated nodules gastric cardia 5 81 F Early satiety, weight loss Thickened folds in antrum EUS findings No visible lesion noted Not performed Intramucosal hypoechoic 10mm lesion Submucosal hypoechoic 1.7cm x 0.7cm lesion, 0.5x0.8cm satellite lesion Not performed VLE balloon size VLE findings Pathology 20mm 20mm 20mm 20mm 20mm Loss of pit and crypt architecture, subtle layering, low scattering mucosal structures Loss of pit and crypt architecture, high surface reflectivity with heterogeneous texture Loss of pit and crypt architecture, high surface reflectivity, clustering of dilated mucosal and submucosal structures Loss of pit and crypt architecture, heterogeneous scattering, dense demarcation between mucosa and low-scattering submucosal structure Loss of pit and crypt architecture. Homogenous scattering. Gastric mucosa, focal IM LGD Part A: adenoma with LGD Part B: adenoma with focal HGD Well differentiated neuroendocrine tumor, low grade (carcinoid), T2 invades muscularis propria Gastric mucosa with IM Figure 1. VLE findings in normal and diseased gastric tissue. (A) Normal gastric tissue has a regular foveolar appearance on VLE, with characteristic pits and crypts presenting as superficial striations in the image. (B) In focal IM with LGD, the corresponding VLE image shows a disruption to the normal pit and crypt architecture, along with increased surface reflectivity. (C) Gastric adenoma with LGD and HGD presents as a loss of pit and crypt architecture with a proliferation of clustered, dilated atypical glands. (D) Finally, a neuroendocrine tumor of the stomach presents as a loss of pit and crypt architecture with a distinct, low scattering submucosal structure, clearly delineated from surrounding tissue. Mo1552 A Proof-of-Principle Assessment of the Role of Light-NBI Endoscopy to Assess High-Risk Phenotype for Gastric Cancer: Endoscopy Replaces Histology? Jorge Lage* 3, Pedro Pimentel-Nunes 3, Pedro C. Figueiredo 1, Diogo Libânio 3, Iolanda Ribeiro 2, Manuel Jácome 4, Luís Afonso 4, Mario Dinis-Ribeiro 3 1 Gastroenterology, Hospital Garcia da Orta, Almada, Portugal; 2 Gastroenterology, Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, Portugal; 3 Gastroenterology, Portuguese Oncology Institute of Porto, Porto, Portugal; 4 Pathology, Portuguese Oncology Institute of Porto, Porto, Portugal Introduction: Patients with extensive intestinal metaplasia and/or those OLGIM stages III-IV merit surveillance leading to early diagnosis of gastric cancer and improvement of patients survival (Dinis-Ribeiro M 2012). High-resolution NBI has been shown to accurately determine the presence of IM at specific sites (Pimentel- Nunes P 2012). We hypothesized that the new Olympus system could be used to estimate extensive intestinal metaplasia (eim) and it could replace or at least be used to target biopsies. Therefore we aimed at assessing the reliability and accuracy of the new Olympus system to assess the presence of eim on a per-patient basis. Methods: A consecutive series of 25 patients (mean age 59.6 years old, 40% male) without known precancerous conditions or lesions in the stomach were submitted to upper gastrointestinal endoscopy using the 190 series of Olympus. Still images recorded using non-magnified pictures with wight-light endoscopy (WLE) of the antrum, angle, corpus lesser curvature in retroversion and greater curvature in anteversion (4 images); at the same positions with light NBI (L-NBI) (4 different images); and 5 magnified images (MAG) using close focus at antrum (lesser and greater curvature), angle and corpus (lesser and greater curvature). With two different levels of expertise, 6 endoscopists were asked to independently and blinded to histology record their suggested diagnosis of the extensive IM according to each technique (WLE only and/or L-NBI; without or with magnified observations). All images were randomly shown between observations. Biopsies from the antrum, incisura and corpus were sent in different vials according to guidelines (MAPS) and OLGIM used as gold standard. Results: The prevalence of OLGIM III/IV stages and eim in this sample was 28% and 40% of patients, respectively (whereas 40% had no IM in endoscopic biopsies). With 21% of images considered to be low quality, 4/6 endoscopists increased their certainty by using WLE+L-NBI+MAG view vs WLE to describe findings and 3/6 increased the global accuracy to estimate OLGIM status and eim. The accuracy to identify those with eim is optimized in all observers comparing WLE with the use of L-NBI and magnified view vs WLE (LR+ from 3,33 to 6,72; LR- from 0,58 to 0,29 for OLGIM III/IV). Also, the inter-observer reliability increased both in trainees and in experts. Conclusions: In this report, for the first time the reliability of endoscopic features for extension of IM is described. Moreover, we conclude that with proper training endoscopic assessment of gastric mucosa can adequately select 3/4 of patients that would merit surveillance (according to OLGIM grade) if biopsies have been performed and that endoscopy alone can detect up to 90% of those with eim. Further validation larger cohorts are crutial to understand the precise accuracy. Summary of results WLE (% (range)) L-NBI (% (range)) WLE+L-NBI (% (range)) WLE+L-NBI+MAG (% (range)) Certainty 45 (20-56) 49 (20-76) 50 (36-60) 64 (48-88) Global proportion of 60 (48-64) 63 (48-76) 65 (56-72) 73 (56-92) agreement with histology Trainees 59 (48-64) 56 (48-60) 61 (56-68) 63 (46-68) Experts 61 (60-64) 69 (56-76) 68 (60-72) 83 (76-92) Global accuracy 58 (44-72) 59 (48-76) 61 (52-76) 64 (52-76) OLGIM Trainees 53 (44-60) 53 (48-60) 57 (52-60) 55 (52-56) Experts 63 (56-72) 64 (52-76) 65 (56-76) 75 (72-76) Sensitivity OLGIM III/IV 50 (29-86) 62 (14-100) 62 (29-86) 74 (43-86) False+ rateolgim III/IV 15 (4-44) 10 (0-28) 13 (4-28) 11 (0-25) Interobserver 0,42 (0,26-0,62) 0,55 (0,39-0,73) 0,50 (0,32-0,68) 0,60 (0,43-0,76) reliability (wk (95%CI)) Trainees 0,33 (0,09-0,59) 0,41 (0,16-0,65) 0,40 (0,15-0,64) 0,44 (0,19-0,67) Experts 0,61 (0,39-0,79) 0,61 (0,39-0,79) 0,70 (0,50-0,84) 0,78 (0,62-0,89) Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB463
69 Mo1553 Is the Recent Who Pathological Classification for Gastric Cancer Helpful in Applying to Endoscopic Resection? Hae Won Kim* 1, Jie-Hyun Kim 1, Hyunki Kim 2, Hoguen Kim 2, Yong Chan Lee 1, Sang Kil Lee 1, Sung Kwan Shin 1, Yong Hoon Kim 1, Jun Chul Park 1, DA Hyun Jung 1, Jae Jun Park 1, Young Hoon Youn 1, Hyojin Park 1, Sung Hoon Noh 3, Seung Ho Choi 3 1 Gastroenterology, Seoul, Korea (the Republic of); 2 pathology, Yonsei university college of medicine, Seoul, Korea (the Republic of); 3 Surgery, Yonsei college of medicine, Seoul, Korea (the Republic of) Background/Aims: Endoscopic resection (ER) has been performed in early gastric cancer with undifferentiated histology (UD-EGC) based on Japanese classification. Whereas, we previously found that different approach is necessary between poorly differentiated (PD) & signet ring cell carcinoma (SRC) for curative resection. However, according to 2010 WHO classification, diffuse type PD and SRC are categorized into the same group as poorly cohesive carcinoma. Thus, we assessed whether the WHO classification is helpful to perform ER of UD-EGC. Methods: Among 3,419 EGC underwent surgery, we analyzed the clinicopathologic features of 1,295 lesions with SRC and PD. We recategorized into intestinal PD, poorly cohesive carcinoma (SRC, diffuse PD), and compared in terms of clinical behavior such as lymph node metastasis (LNM). We also recategorized 190 lesions (63 PD; 127 SRC) treated by ER into intestinal PD, poorly cohesive carcinoma (SRC, diffuse PD), and compared in terms of outcomes of ER. Results: According to surgical data, the rate of LNM was high in order from intestinal PD, diffuse PD and SRC (15.8%, 13.5%, and 6.3%). Similarly, the rate of LVI was significantly lowest in SRC compared with diffuse and intestinal PD. When compared between diffuse PD and SRC categorized as poorly cohesive carcinoma, the rate of LNM and LVI was significantly higher in diffuse PD than SRC. According to ER data, there was no recurrence in all of them if curatively resected. However, the most common cause of non-curative resection was different between SRC and PD irrespective of intestinal or diffuse type. The most common cause was positive lateral margin in SRC, whereas positive vertical margin in both intestinal and diffuse PD. Conclusions: Clinical behaviors are different between diffuse PD and SRC categorized as poorly cohesive carcinoma in WHO classification. Considering LNM and outcomes of ER, the recent WHO classification may not be helpful to perform ER for UD-EGC. (mm 2 ) range: 5000 and!10000, moderate AG CA: 3000 and!5000. Severe AG CA was!3000. Quadratic polynomial regression established a statistically significant relationship between CA and inter-crypt space. Conclusions: Using p-cle criteria, severity of AG could be defined thought crypt area and inter-crypt space with values of!3000mm 2 and 40mm respectively. Mo1554 Grading Atrophic Gastritis by a New Quantitative Method Using Confocal LASER Endomicroscopy Probe (P-CLE): First Results of a Prospective Cohort Study Carlos Robles-Medranda*, Miguel Puga-Tejada, Jesenia Ospina, Miguel Soria Alcívar, Gladys Bravo Velez, Raquel S. Del Valle, Hannah P. Lukashok Endoscopy, Ecuadorian Institute of Digestive Diseases, Guayaquil, Ecuador Background: Atrophic gastritis (AG) is a chronic disease, associated to gastric adenocarcinoma moreover if severity AG is present. Sydney system classified AG as mild, moderate and severe, but with moderate interobserver agreement, due to this system is based in a visual analogic scale (qualitative analysis). Confocal endomicroscopy showed an accuracy of 98% for diagnosis gastric diseases, but when grading AG still remains a qualitative measure. Recently, a new software called CellvizioÒ Viewer (CV) permits to measure in micrometers (mm) the structures observed after p-cle studies. Based on the hypothesis that AG severity is correlated with crypts size diminution, the aim of this study is to determine a quantitative way to classify the severity of AG measuring the crypt area and inter-crypt spaces in patients with AG. Methods: After approval by the ethics committee 200 consecutive patients that underwent to upper endoscopy (UE) evaluation were included in this prospective study. Inclusion criteria: dyspepsia O12 months, age R18, no history of UE evaluation, AG at histopathology, acceptance to participate. Exclusion criteria: use of PPI s, antibiotics or NSAID s, gastric cancer, gastric surgery, pregnancy, contraindication to fluorescein. During UE 5 biopsy sites were performed in accordance to Sydney system first using p-cle and them by biopsy forceps from the same site. At p-cle normal crypt was defined by using the classification of Wang et al (1). After histopathology confirm AG, crypts were analyzed using the CV software measuring the crypts diameters, to determine the area by elliptic area formula (A Z p.d 1.d 2 ) and measuring inter-crypt space. That space was defined as the mean of each measured distance between the studied crypt and it s adjacent. The cutoff value between mild, moderate and severe AG, crypts area was classified across tertiles, expressing its distribution using a box-spot graphic. For relationship between crypt area (CA) and inter-crypt space, quadratic polynomial regression was used. Data was processed using IBMÒ SPSSÒ Statistics. Results: 30 patients were identified to have AG, 16 females (55%) with a mean age of and 146 crypts were analyzed. Histopathology showed AG: absent in 10 (38.5%), mild 8 (30.8%), moderate 6 (23.1%) and severe 2 (7.7%) of cases. At p-cle the mean CA was 4697 ( ), and average of mean inter-crypt distance was ( ). Minimum normal CA was mm 2. Classifying AG crypts was established as follow: mild atrophic CA AB464 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
70 Mo1555 Computer-Aided Decision Support System in Gastric Pathology Assessment: Preliminary Experimental Study Roman Kuvaev* 1, Sergey V. Kashin 1, Herbert Edelsbrunner 2, Olga A. Dunaeva 3, Daria Malkova 3, Evgeny Nikonov 4, Viktor Kapranov 5, Alexander Rusakov 6 1 Endoscopy, Yaroslavl Regional Cancer Hospital, Yaroslavl, Russian Federation; 2 Institute of Science and Technology Austria (IST Austria), Klosterneuburg, Austria; 3 Delone Laboratory of Discrete and Computational Geometry, P.G. Demidov Yaroslavl State University, Yaroslavl, Russian Federation; 4 Healthcare Department, Moscow, Russian Federation; 5 Internet Center of P.G. Demidov Yaroslavl State University, Yaroslavl, Russian Federation; 6 P.G. Demidov Yaroslavl State University, Yaroslavl, Russian Federation Introduction: Advanced endoscopic techniques such as high-magnification endoscopy with narrow-band imaging (HME-NBI) have been used for diagnosis of gastric pathology because of its high accuracy. Nevertheless, its application in clinical practice is difficult due to the presence of various histological changes of gastric mucosa with different modifications of microvascular (MV) and microsurface (MS) patterns. Newly developed computer-aided decision support systems in endoscopy have recently been designed to detect, classify and predict pathologies. It assists a medical expert in improving the accuracy of medical diagnosis and thus could be utilized with novel techniques like HME-NBI, requiring a high level of experience. However, there is lack of data for computer-aided devices for classification of gastric lesions with HME-NBI. Aims & Methods: The main goal of this study was to design and test an effective computer-aided classification system of endoscopic magnification images of gastric lesions. We applied the image processing techniques for highlighting MV and MS pattern for further extracting of geometrical features (square, perimeter, radius, elongation, compactness of connectivity components). The main innovative aspect of our work was the use of topological features derived from the persistent homology of the images. For multi-class classifier creating we used a naive Bayesian approach to combine results of several binary Adaboost classifiers. We selected and analyzed 90 endoscopy NBI magnification images of gastric lesions from endoscopic database (Olympus Exera GIF Q160Z, Lucera GIF Q260Z). All images were classified into three types according to the well-known MV and MS pattern classifications: oval (25 images), tubular (31 images), and irregular (34 images). Initially we divided images of every class into two sets d a training set and a test set. Training and testing were subsequently performed for every image by leave-one-out cross-validation (LOO-CV) and bootstrap method. Results: The results obtained with LOO-CV protocol the bootstrap method were very similar. The most images had correctly recognized neighborhoods between 90% and 100%. The average of correctly recognized neighborhoods was 89%, with a variance of 4.4%. Conclusion: Topological features were successfully used for description of endoscopic magnification images. The combination of topological features analyzed with Adaboost algorithm allowed for creating and effective training of computeraided classifier of endoscopic magnification images of gastric lesions. Our computeraided classification system could provide effective recognition of three main types of gastric mucosal patterns and thus may lead to pathology predict ion and supporting of clinical decision. Computer-aided analysis of HME-NBI image: brown area indicates disappearance of microsurface structure and irregular microvessel network (neoplastic lesion), blue color of background indicates regular tubular structure (metaplastic mucosa). Mo1556 Novel Gastric Gastric Mucosal Changes Induced by Use of Pproton Pump Inhibitor Shuichi Miyamoto* 1, Mototsugu Kato 2, Shouko Ono 2, Katsuhiro Mabe 1, Yuichi Shimizu 1, Naoya Sakamoto 1 1 Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan; 2 Division of Endoscopy, Hokkaido University Hospital, Sapporo, Japan Background: Use of proton pump inhibitor (PPI) is associated with parietal cell protrusions and oxyntic gland dilatations. It is generally accepted that PPI use develops fundic gland polyps by its effect on parietal cells. However, we often detect endoscopically two interesting mucosal changes in the patients with PPI use such as cobblestone like mucosa (CSM) and cracked mucosa (CM) of fundic gland area. The aim of this study was to clarify the relationship between PPI use and these mucosal changes. Methods: We conducted a single-center prospective observational study. All successive subjects who booked for routine esophagogastroduodenoscopy between September and November 2014 in Hokkaido University Hospital were enrolled. Subjects were excluded if any of the following criteria applied: any gastric neoplasms or active ulcer; a past history of gastrectomy; serious complications; unknown use of medicine. One blinded endoscopist checked CSM and CM findings using all recorded images. H. pylori infection was assessed by more than two reliable diagnostic tools. Subjects were divided into two group; use of PPI (PPI) and non-use of PPI (control), and compared with endoscopic findings and background between both groups. Results: We finally analyzed a total of 561 patients. PPI and control group were 187 subjects (M/F: 88/99, median age:71), and 374 patients (M/F:204/ 170, median age: 66). CSM was totally detected in 18 (3.2%) subjects, CM in 59 (10.5%) subjects. The prevalence rate of CSM were significantly higher in PPI group (8.0%:15/187) than in control group (0.8%:3/374) (p!0.01). Also there was significant difference in the prevalence rate of CM between PPI group (24.1%:45/187) and control group (3.7%:14/374) (p!0.01). The prevalence rate of CLM or CM were not affected by H. pylori infection and the period of PPI use. Conclusion: Novel endoscopic findings of cobblestone like mucosa and cracked mucosa in fundic gland area were suggested to be strongly associated with PPI use. HME-NBI: small area with disappearance of microsurface structure and irregular microvessel network (histology showed well-differentiated adenocarcinoma) on the background of mucosa with regular tubular microsurface structure and regular microvesels. Mo1557 Outcomes of Enteral Stent Placement to Relieve Duodenal Obstruction Caused by Pancreatico-Biliary Cancers: Results From a Large Retrospective Cohort. Chanakyaram A. Reddy, Stephen Hasak*, Srinivas Gaddam, Steven A. Edmundowicz, Daniel Mullady, Faris Murad, Vladimir M. Kushnir Medicine, Washington University School of Medicine, St Louis, MO Background: Malignant duodenal obstruction if a frequent complication of advanced stage pancretico-biliary (PB) cancer. Self-expanding metal stents (SEMS) have been established as a safe and effective means of palliating duodenal obstruction in patients with advanced malignancy. However, the safety and durability of SEMS in Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB465
71 patients receiving intensive oncologic therapy is unclear. Aim: To evaluate the clinical outcomes of patients following SEMS placement and identify risk factors for SEMS related adverse events (AE). Methods: Consecutive patients undergoing enteral SEMS placement for treatment of duodenal obstruction resulting from primary pancreatic or biliary malignancy at a single tertiary care center between 2008 and 2014 were retrospectively identified. Subjects were excluded if 1) a surgical bypass or Whipple resection had been performed prior to SEMS placement 2) no follow up data was available. Demographics, clinical characteristics, success rates and SEMS related adverse events (AE) were recorded. AE were categorized as early (!7 days) and late (O7 days). Results: 130 patients (average age years, 47.7% female) underwent SEMS placement for palliation of duodenal obstruction due to PB cancer. The technical success of SEMS placement was 100% and there were no immediate complications. 33 patients were excluded, 8 had undergone a surgical bypass prior to SEMS placement, and 25 due to lack of follow up data. 97 patients (average age 65.3+/-9.8 years, 46.4% female) met the inclusion and exclusion criteria. There were 4 early AEs [3 stent occlusions, 1 gastrointestinal (GI) bleeding]. 31 (32.0%) patients experienced late SEMS related AE. AEs included 24 stent occlusions, 7 GI bleeds, and 3 perforations. SEMS related AEs were not associated with baseline demographics or post-stent cancer therapy (table 1). SEMS related adverse events were treated with repeat endoscopic intervention in 17, surgery in 3, and supportive measures in 11 cases. Following SEMS placement 30 patients underwent repeat upper endoscopy for evaluation and treatment of suspected complications. On Kaplan-Meyer analysis, the median time to a SEMS related AE was 225 (95% CI, ) days. When patients were stratified on the basis of post-sems oncologic therapy (chemotherapy vs. chemo-radiation vs. palliative care alone) there was no difference in the median time to SEMS related AE (figure 1, log rank pz0.43). Conclusion: SEMS placement is a safe and effective treatment of malignant duodenal obstruction in patients with locally advanced PB cancer. While 32% of patients do develop SEMS related AE during long term follow up, the majority of these are amendable to endoscopic intervention. Finally, we observed that aggressive oncologic therapy is not associated with an increased rate of SEMS related AEs. Table 1 Complication (n [31) No Complication (n [66) P value Age (years) Gender 0.48 Female Male Primary Malignancy 0.21 Pancreatic cancer Cholangiocarcinoma 8 10 Post-SEMS Therapy 0.75 No Post-stent chemo or XRT Post-stent chemo Post-stent chemo+xrt 5 8 Mo1558 Comparison of the Effectiveness of Endoscopic Duodenal Stent Placement and Surgical Gastrojejunostomy for Gastric Outlet Obstruction in Patients With Advanced Pancreatic Cancer Shinya Uemura* 1, Takuji Iwashita 1, Mitsuru Okuno 1, Masanori Nakashima 2, Yasuhiro Ohshima 3, Keisuke Iwata 4, Katsuhisa Toda 5, Takaya Ohnishi 6, Tsuyoshi Mukai 2, Takafumi Sekino 7, Shinji Osada 8, Ichiro Yasuda 9, Masahito Shimizu 1 1 First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan; 2 Gastroenterological Internal Medicine, Gifu Municipal Hospital, Gifu, Japan; 3 Department of Gastroenterology, Murakami Memorial Hospital Asahi University, Gifu, Japan; 4 Gastroenterological Internal Medicine, Gifu Prefectural General Medical Center, Gifu, Japan; 5 Department of Gastroenterology, Chuno Kosei Hospital, Gifu, Japan; 6 Gastroenterological Internal Medicine, Hashima Municipal Hospital, Gifu, Japan; 7 Department of General and Cardiothoracic Surgery, Graduate School of Medicine Gifu University, Gifu, Japan; 8 Surgical Oncology, Gifu University School of Medicine, Gifu, Japan; 9 Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa, Japan Background: Gastric outlet obstruction (GOO) is often seen in patients with advanced pancreatic cancer (APC) and can severely affect quality of life. Traditionally, GOO was managed with surgical gastrojejunostomy (GJ). However, endoscopic duodenal stenting (DS) has become increasingly popular due to its less invasive nature. Aim: To compare the efficacy and safety of DS and GJ as palliative treatment for GOO in patients with APC. Patients and Methods: The study included 86 consecutive patients with GOO due to APC, who underwent DS (nz52) or GJ (nz34) between 12/ 2008 and 10/ GOO scoring system (GOOSS) was used as an index of clinical success. Other clinical outcomes of interest included technical success rate, length of hospital stay, adverse event rate, and survival duration. Prognostic factors for overall survival were investigated by univariate and multivariate analyses. Results: Comparison of the baseline characteristics of the 2 groups (DS:GJ) showed no difference in sex (female, 27:22; pz0.51); site of obstruction (D1, 12:5; D2, 22:15; D3, 18:14; pz0.60); presence of metastases (31:22; pz0.66); presence of obstructive jaundice (38:21; pz0.31); mean GOOSS (0.7:0.7; pz0.31); and chemotherapy after the procedure (22:19; pz0.27). The DS group had a significantly higher mean age (72.0:68.1; p!0.05) and a poorer mean performance status (PS) (2.3:1.7; p!0.001). Technical success rates were 98% (51/52) and 100% in DS and GJ, respectively (pz1.00). The time (days) to resumption of oral intake was significantly shorter following DS (liquid, 1.6:3.5; p!0.01; soft solids, 2.6:6.3; p! ). However, there was no difference in mean maximum GOOSS (2.6:2.7; pz0.81). The clinical success rates (GOOSSR2) were 83% (43/52) and 91% (31/34) in DS and GJ, respectively (pz0.19). The mean length of hospital stay (days) was significantly shorter following DS than after GJ (17.4:34.1; p!0.01). Early adverse event rates did not differ (DS, 5.8%: perforation (1), pneumonia (1), insufficient stent expansion (1); GJ, 11.8%: wound infection (2), bleeding (1), diarrhea (1); pz0.43). There was also no difference in the rate of late adverse events (DS, 17.3%: stent occlusion (7), perforation (2); GJ, 8.8%: anastomosis obstruction (2); ileus (1); pz0.35). Univariate and multivariate analyses of prognostic factors for overall survival showed PS %2 (HR 0.49, 95% CI ), post-procedural chemotherapy (HR 0.27, 95% CI ), and DS (HR 2.16, 95% CI ) to be significant factors. Conclusions: In the management of GOO in APC, DS showed high technical and clinical success rates, similar to those of GJ. DS was associated with an earlier resumption of oral intake and shorter hospital stays compared with GJ. However, survival duration was longer in GJ, especially in patients with PS %2. Therefore, GJ should be considered in patients with good PS. Figure 1. Time to SEMS related complication Mo1559 Does Palliative Enteral Stenting in Malignant Gastrointestinal Outflow Obstruction Make a Difference? Usman I. Aujla*, Majid Khan, Asad H. Bashir, Sameer Zar St Helier Hospital, Gastroenterology, Epsom and St Helier University Hospitals, NHS Trust, London, United Kingdom Introduction: Malignant gastric outflow obstruction can be due to intrinsic mucosal disease or secondary to extrinsic compression. The cause of this is multifactorial due to obstruction and gastric dysmotility.this can be treated with a surgical gastro-enterostomy or by gastro-enteric stenting. Both modalities have been compared in recent trials with mixed clinical outcomes. We describe our experience of enteral stenting in this cohort of patients with often-reduced life expectancy. Aims and Methods: The aim of this study was to assess the role of enteral stents (duodenal and pyloric) as a palliative procedure in advanced malignant disease resulting in gastrointestinal outflow obstruction. The integrated hospital electronic database system was reviewed retrospectively over a period of 3 years (January 2011 to December 2013) and analysed for the following: clinical details, radiology, endoscopy and histology. Results: Fully uncovered self expandable metal stents (SEMS) were placed in 28 patients (12 males and 16 females) with mean age of years (range 53-94y). Duodenal stents were placed in 22(79%) patients, pyloric in 4(14%) and combined duodenal and pyloric stents in 2(7%). Eastern cooperative oncology AB466 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
72 group performance status (ECOG-PS) was 0 in 3 patients, 1 in 11 patients, 2 in 11 patients and 3 in 3 patients. The main indications for stent placement were pancreatic adenocarcinoma with duodenal infiltration in 13 (46.4%) patients, gastric adenocarcinoma in 7 (25%), cholangiocarcinoma in 3 (10.7%), duodenal adenocarcinoma in 3 (10.7%) and 1 (3.6%) in each of small bowel adenocarcinoma and gall bladder adenocarcinoma. Technical success rate for stent deployment was 100% and oral intake was possible in all (100%) of the stented patients with 93% of patients being capable of eating at least a mechanical soft diet. There were no sedation related adverse events and procedure related complications including perforation and haemorrhage. Among late complications there were 3 (10.7%) stent obstructions related to tumour ingrowth requiring re-insertion of stents and 1 (3.5%) biliary obstruction requiring biliary stent insertion. The mean survival from stent placement to death was 111 days (range 9-438). Three patients (11%) were still alive after an average of 250 days post stent deployment. 30 days mortality was 6 (21%) but this was related to advance malignant disease rather related to endoscopic stent placement. Conclusion: In our experience enteral stenting is a safe palliative procedure and it improves quality of life by relieving gastrointestinal obstruction and restoration of enteral tract for nutrition in all successfully stented cases. Enteral stenting contributed towards an average survival of around four months and hence must be considered in this high risk group of patients. Mo1560 Validity of Endoscopic Submucosal Dissection for Early Gastric Cancer in Super-Elderly Patients With Concomitant Diseases Yoshikazu Yoshifuku* 1, Yoji Sanomura 1, Shinji Tanaka 1, Tomohiro Miwata 1, Norifumi Numata 1, Shiro Oka 1, Toru Hiyama 1, Kazuaki Chayama 2 1 Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan, Hiroshima, Japan; 2 Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan Background: Opportunities to perform endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) in super-elderly (R85 years) patients have increased as the aging society in Japan advances. However, these patients often have concomitant disease, and few studies have confirmed the safety of ESD for EGC in this patient group.object: To evaluate the validity of ESD for EGC in super-elderly patients with concomitant disease. Patients and Methods: We studied 78 super-elderly patients with 95 EGCs resected by ESD at Hiroshima University Hospital between 2002 and Patients were classified into two groups: Group A, patients with concomitant disease (37 patients/47 EGCs) and Group B, patients without concomitant disease (41 patients/48 EGCs). We investigated complete resection rate, non-curative resection rate, complications, and prognosis in each group. Regarding prognosis, Group A was divided into 2 groups according to American Society of Anesthesiologists physical status (ASA-PS) classification: Group A-H, patients with high-risk concomitant disease (18 patients, ASA-PS class 3/4) and Group A-L, patients with low-risk concomitant disease (19 patients, ASA-PS class 1/2). Concomitant disease included heart disease (nz12), diabetes (nz9), cerebral vascular disease (nz5), and others (nz16), with some overlap. We also investigated 7 patients (Group C) diagnosed as having EGC but who were followed up without ESD for various reasons. Results: Complete resection rates were 94% (45/47) in Group A and 100% (48/48) in Group B. Delayed bleeding rates were 6% (3/47) in Group A and 0% (0/48) in Group B. Perforation rates were 0% (0/47) in Group A and 4% (2/48) in Group B. Differences in these variables between Groups A and B were not significant. Non-curative resection rates were 17% (8/47) in Group A and 23% (11/48) in Group B. No patients in Group A and 2 patients in Group B underwent additional surgical resection. In November 2014, 32 patients in Group A and 36 in Group B could be followed up. Among them, 10 (31%) patients in Group A, 1 (4%) patient in Group B, 5 (28%) patients in Group A-L, and 5 (26%) patients in Group A-L had died, indicating a significantly higher frequency of death in Group A than Group B(p!0.01) and no significant differences between Groups A-H and A-L. Causes of death were pneumonia (nz4), cancer of other organs (nz2), and others (nz4) in Group A and pneumonia (nz1) in Group B. No patients died of GC. In group C, 5 (71%) patients died from advanced GC (nz1), pneumonia (nz2), and others. (nz2). Conclusion: We could perform ESD safely in super-elderly patients with concomitant disease regardless of the degree of disease. However, patients with concomitant diseases are at high risk for poor prognosis, and indications for ESD should be determined carefully depending on the patient s general condition. Mo1561 Clinical Outcome of Absolute Versus Expanded Indication of Endoscopic Submucosal Dissection for Early Gastric Cancer Chang Beom Ryu*, Moon Sung Lee Soon Chun Hyang University, Bucheon, Korea (the Republic of) Background: The treatment of early gastric cancer (EGC) by endoscopic submucosal dissection (ESD) has been rapidly gaining popularity in Korea. Current guidelines for endoscopic management such as EMR and endoscopic submucosal dissection (ESD) in early gastric cancer (EGC) are in evolution, with broader indication criteria.in Korea, indication of ESD for early gastric cancer have been still one of big issue. Aim: The purpose of this retrospective comparative study was to evaluate clinical outcome of ESD for EGC, based on absolute indication and expanded indication criteria, Method: ESD was performed on 1102 cases of early gastric neoplasm (cancer: 631, dysplasia: 471) from Jan 2002 to Aug 2011 at Soon Chun Hyang University Bucheon Hospital.According to final diagnosis, EGC s below were enrolled by two groups (absolute vs expanded) and followed up: absolute: differentiated intramucosal (IM) cancer less than 20 mm, expanded: differentiated-type intramucosal cancer less than 30 mm in diameter or minute sm invasion (! 500 mm from the muscularis mucosa) or undifferentiated IM cancer less than 10 mm. Results: En bloc and complete resection rate in absolute and expanded group were94.1% vs 90.7%, 93.7% vs 88.5% (NS).Size of lesion was mm, mm (p!0.05). Complication such as bleeding and perforation was no statistical difference (po0.05). There was no between-group difference in the local recurrence rate (1.4% vs1.8%; NS) at a median follow-up period of 28 months (interquartile range 6-48 months). Conclusion: Higher en bloc resection and complete resection rate, lower complication and recurrence in expanded group of ESD for EGC revealed as absolute group.we concluded indication of ESD for EGC can be expanded Mo1562 Evaluation of Esophageal and Gastric Varices by CT Portal Venography for Prophylactic Endoscopic Therapy of Variceal Hemorrhage Zijin Cui* 1, Zhijie Feng 1, Haiqing Yang 2, Huiqing Jiang 1, Wei Qi 1, Wenfeng Feng 2 1 Gastroenterology, The Second Hospital of Hebei Medical University, Shijiazhuang, China; 2 Radiology, The Second Hospital of Hebei Medical University, Shijiazhuang, China Background and Aims: CT portal venography (CTPV) is increasingly widely used in the evaluation of collateral circulation in portal hypertension. This study aims to identify imaging features of esophageal and gastric varices (EGV), investigate the concordance between CTPV and endoscopy, and assess the efficacy of endoscopic treatments in patients with EGV using CTPV. Methods: EGV of 33 cirrhosis patients with history of variceal hemorrhage were evaluated by CTPV and subsequent endoscopy. The presence, grading and classifications of EGV at endoscopy and CTPV were compared (Kappa test). Maximum intensity projection (MIP) and volume rendering (VR) were performed to analyze portosystemic collaterals and measure diameters of portal vein and its major tributaries. 24 cases were treated endoscopically, and efficacy of treatments was radiologically assessed as ineffective, moderate effective or effective after one week and then one mouth of time. Results: In detecting and grading of EV, substantial agreement (k value: and 0.684) was indicated by Kappa test, and substantial agreement (k value: and 0.739) was also shown in detecting and classifications of GV. Among 33 cirrhosis patients with EGV, the left gastric vein and azygos vein were recognized as main afferent (84.8%) and efferent (81.9%) vessels. Besides EGV, 1 case of duodenal varix (3.0%), 21 cases of paraesophageal varices (63.6%), 5 cases of abdominal wall varices (15.2%), 2 cases of paravertebral varices(6.2%), and 17 cases of spontaneous splenorenal and gastrorenal shunts (51.5%) were identified by CTPV. One week after endoscopic treatment, significant decline (from cm to cm) of the diameter of left gastric vein was detected by CTPV, and then a significant reduction (from cm to cm) was shown one mouth after treatments, while no significant change was detected in the diameters of portal vein, splenic vein, and superior mesenteric vein. Among the 16 cases with EV treated endoscopically, overall efficacy of treatments was 37.5% and 62.5% one week and one month after operations respectively. Among the 12 cases with GV who underwent endoscopic therapy, overall efficacy was 25% and 58.3% one week and one month after treatments respectively. Conclusion: CTPV depicts portal vein system and portosystemic collaterals non-invasively and efficiently, especially for varices outside the gastroesophageal region which can t be detected by endoscopy. CTPV was in substantial agreement with endoscopy in evaluating the presence, grading and classifications of EGV and it provides informative reference to evaluate efficacy of endoscopic therapy in patients with EGV. Mo1563 A Multicenter Experience of Through-the-Scope Balloon-Assisted Deep Enteroscopy in Surgically Altered Gastrointestinal Anatomy Jennifer X. Cai 1, David L. Diehl 2, Ralf Kiesslich 3, Andrew Storm 1, Mohamad H. El Zein 1, Alan H. Tieu 1, Mouen Khashab 1, Patrick I. Okolo 1, Vivek Kumbhari* 1 1 Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, MD; 2 Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, PA; 3 Klinik für Innere Medizin II, HSK, Dr. Horst Schmidt Kliniken GmbH, Wiesbaden, Germany Background: Patients with surgically altered gastrointestinal anatomy pose challenges for deep enteroscopy. Current platforms have success rates between 61-88% in this population, but lack widespread availability and have limited therapeutic potential due to a smaller working channel. Through-the-scope balloon-assisted enteroscopy (TTS-BAE) marketed as NaviAid AB (Smart Medical Systems Ltd., Ra anana, Israel) is a novel technique using a standard adult colonoscope that allows for a broader range of interventions through the larger working channel but may be hampered by a shorter depth of maximal insertion. Aim: To determine the efficacy Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB467
73 and safety of TTS-BAE in patients with altered surgical anatomy. Methods: A retrospective multicenter (2 in U.S., 1 in Germany) study of consecutive TTS-BAE was performed from 2012 to Target success was defined as ability to access the intended target. Technical success was defined as completion of the procedure as intended. Clinical success was defined as O50% reduction in abdominal pain or hepatic enzyme levels and resolution of jaundice or bleeding. Adverse events were graded according to the ASGE lexicon s severity grading system. Results: A total of 40 patients (mean age 53yr, 17 female) with altered surgical anatomy had TTS-BAE performed (Table 1). All were anterograde enteroscopies with a median procedure time of 41 minutes (25-250). The most common indication was for treatment of biliary or intestinal obstruction (nz30, 75%), while the most frequent target of TTS- BAE was at the surgical anastomosis (nz30, 75%). Overall, the intended target was reached in 57.5% (nz23), of which 95.65% (nz22) were technically successful and 91.3% (nz21) were clinically successful. The Roux-Y (RY) limb and deep bowel had the highest rates of target reached, technical and clinical success (Table 1). Success rates did not differ between patients with RY anatomy of any kind and those with non-ry anatomy (PZ0.62, 0.94, 0.8). A total of 6 metal stents and one 10Fr plastic stent were successfully deployed (4 biliary, 2 jejunal); this would not have been possible using other platforms. The mean number of unplanned repeat interventions was lower after technically successful TTS-BAE (0.22) compared to unsuccessful cases (1.22, P! ). Adverse events occurred in 3 (7.5%) cases: aspiration pneumonia (mild), cholangitis (mild) and perforation (severe) distal to the HJ requiring surgical closure. Conclusions: TTS-BAE does not reach the therapeutic target as often as conventional platforms possibly due to its shorter depth of insertion and the less flexible adult colonoscope; however, we demonstrate very high technical and clinical success rates once an intended target is reached, which can be particularly useful for metal stent deployment in RY anatomy. Table 1. Success rates of TTS-BAE by surgical anatomy, indication, and intended target N (%) Target success (%) Technical success (%) Clinical success (%) Type of anatomy RYGB 7(17.5) Transplant RYHJ 7(17.5) Non-transplant RYHJ 11(27.5) Whipple 10(25.0) Other 5(12.5) Indication for TTS-BAE ERCP 31(77.5) Biliary stricture 18(45) Choledocholithiasis 5(12.5) Pancreatic stricture 2(5) Small bowel stricture 5(12.5) Malignant 2(5) Benign 3(7.5) GI bleeding 4(10) Target of TTS-BAE Hepaticojejunostomy/ 30(75) Jejunojejunostomy Deep bowel 4(10) Biliopancreatic limb 4(10) Roux limb 1(2.5) Excluded stomach 1(2.5) Mo1564 Refractory Gastroparesis Can Be Successfully Managed With Endoscopic Transpyloric Stent Placement and Fixation Mouen Khashab*, Sepideh Besharati, Saowanee Ngamruengphong, Vivek Kumbhari, Mohamad H. El Zein, Ahmed Abdelgelil, Alan H. Tieu, Gerard E. Mullin, Ellen M. Stein, Sameer Dhalla, Monica Nandwani, Vikesh K. Singh, Marcia I. Canto, Anthony N. Kalloo, Pankaj J. Pasricha, John O. Clarke Johns Hopkins Medical Institute, Baltimore, MD Background: Medical treatment options for gastroparesis are limited. Data from studies of botulinum toxin and pyloroplasty suggest that disruption of the pylorus can result in symptomatic improvement in some patients with refractory gastroparetic symptoms. We previously performed a pilot study that demonstrated improvement of symptoms in 4 patients with gastroparesis treated with transpyloric stent placement (TPS). AIMS: To (1) determine safety and efficacy of TPS placement for refractory gastroparesis; and (2) evaluate whether various stent fixation techniques had impact on stent migration rate and clinical outcome. Methods: Patients with gastroparesis refractory to medical treatment were referred for TPS. A throughthe-scope fully covered self-expandable metallic esophageal stent was deployed across the pylorus. In fixation group, the stent was anchored to the gastric wall with either endoclips, over-the-scope clip (OTSC) or endoscopic suture (ES: placed in 2 locations between stent and gastric wall). Self-reported symptom improvement, stent migration rate and post-stent gastric emptying study (GES) results were collected. Time to migration was compared using Kaplan Meier estimate. Results: A total of 29 patients (20 female, mean age 39yr) with refractory gastroparesis (idiopathic 16, diabetic 8, post-surgical 5) underwent 47 TPS procedures. Of these, 25/47 (53%) were performed in patients admitted to the hospital with intractable symptoms. Most (nz24, 83%) had predominant symptoms of nausea (N) and vomiting (V). Successful stent placement was achieved during 46 (98%) procedures. Most stents were anchored to the gastric wall using ES (nz23), followed by OTSC (nz18) and endoclip (nz2). Three patients did not receive stent fixation. Overall, 20/27 (74%) patients had clinical response (2 patients were lost to follow-up). All inpatients were successfully discharged after stent placement. Clinical success was higher in patients with predominant N/V compared with those with abdominal pain/bloating (95% vs. 71%, pz0.12) (table 1). Repeat GES was performed in 16 patients: mean 4hr GE normalized in 5 patients (76% vs. 98%, pz0.2) and significantly improved in 4 (54% vs. 73%, pz0.02). Stent migration occurred in 59% of procedures: 100% in the no fixation group, 50% in the endoclip group, 71% in the OTSC group, and 48% in the ES group (po0.05 for all comparisons). During a mean follow up of 146d, time to stent migration was not different between ES and other groups (PZ0.9). Conclusion: TPS is a promising novel endoscopic treatment modality for gastroparesis and improves both symptoms and gastric emptying in patients refractory to medical treatment, especially those with N/V. TPS can be considered as salvage therapy for inpatients with intractable symptoms. Questions regarding long-term durability and stent migration risk remain. Predictors of clinical response after transpyloric stent placement With clinical response(20) Without clinical response(7) OR P value Confidence interval 95% age Female (%) 14(70) 5(71) Etiology, idiopathic 10(50) 4 (57.14) gastroparesis (%) Predominant nausea and vomiting 19(95) 5(71) TTS-BAE Mo1565 Trans-Fistulary Drainage for Post-Bariatric Abdominal Collections Communicating With the Upper Gastrointestinal Tract. Simon Bouchard* 1,2, Pierre Eisendrath 2, Emmanuel Toussaint 3,2, Olivier Le Moine 2, Arnaud Lemmers 2, Jacques Deviere 2 1 Gastroenterology, Centre Hospitalier de l Université de Montréal, Montréal, QC, Canada; 2 Gastroenterology, Hepatopancreatology and Digestive Oncology, ULB Erasme Hospital, Brussels, Belgium; 3 Gastroenterology, ULB Brugmann University Hospital, Brussels, Belgium Background and Aim: Certain patients with leaks or fistulas following bariatric surgery do not respond to usual endoscopic methods, such as temporary stenting, because of anatomic particularities, delayed management and/or collections not properly drained percutaneously. In these patients with post-bariatric surgery collections, we have hypothesized that successful treatment could be achieved using trans-fistulary drainage with double pig-tail plastic stents. Methods: We performed a retrospective analysis of patients with post-bariatric surgery abdominal collections communicating with the upper GI tract treated by trans-fistulary stenting between May 2007 and September Clinical success was defined as a sustained (median 5, range months at the time of abstract submission) clinical resolution and biological normalization. Patient s records, radiologic images and our endoscopic AB468 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
74 database were reviewed to collect data. Results: 25 patients (17 women/8 men, mean age years) were included. Post-operative collections occured after sleeve gastrectomy in 20 patients and after gastric bypass in 5. A median of 48 days (range ) elapsed between initial surgery and transfistulary stenting. 11 patients were treated by transfistulary stenting as primary treatment, while 14 patients had previously failed treatment attempts with one or more endoscopic methods (endoprosthetics, clips and/or fistula plugs). Internal drainage was initially maintained by placement of 2 double pigtail stents (7 or 8.5 Fr ) in 21 patients or by one stent and a naso-cystic catheter in 4. In 5 patients, transfistulary stenting was combined with percutaneous drainage. No complication occurred during the initial drainage procedure. In 6 patients, trans-fistulary stenting was not successful and surgery was necessary. Clinical success was achieved in 19 patients (76%). In 7 successfully treated patients, stents are still in place after a median stenting duration of 102 days (range ) and no complication has occurred. In 4 patients with spontaneous stent migration, no complication has occurred after a median follow-up duration of days (range ). In 8 patients, the plastic stents have been removed after a median stent indwell duration of days (range ) and no complication has occurred after a median follow-up duration of days (range 5-461). In these patients, stents were either removed electively (2 patients) or because of dysphagia or symptomatic stent-induced esophageal ulcerations (6 patients). Conclusions: Trans-fistulary drainage of post-bariatric abdominal collections is safe and is associated with high success rates. This technique seems promising and can be considered either in previously untreated patients when a collection is present and not properly drained percutaneously or after failure of other endoscopic treatments. Mo1566 Utility of Double Balloon Enteroscopy in Patients With Surgically Altered Bowel Anatomy After Bariatric Surgery Shabnam Sarker, Shajan Peter, Ivan Jovanovic, Helmut Neumann, Monkemuller Klaus* Basil I Hirschowitz Endoscopic Center of Excellence, University of Alabama, Birmingham, AL Background: Endoscopic investigation of the gastrointestinal (GI) luminal and pancreatobiliary tracts in patients with surgically-altered GI anatomy after bariatric surgery is challenging and often impossible. The advent of balloon-assisted enteroscopy (BAE) has increased our ability to navigate through the surgically altered bowel. Despite the existence of BAE since more than a decade there is few data available on it potential utility for evaluation post-obesity-surgery patients. Aims: To evaluate the diagnostic yield, success and complications rates of double-balloon enteroscopy (DBE) in consecutive patients with GI problems necessitating endoscopic evaluation. Materials and Methods: Single-center, observational, cohort study of consecutive patients with post-obesity-surgery undergoing DBE during a 24-months period. Patients demographics, procedure indications, findings, endoscopic interventions, and post-procedural recovery data were recorded. Results: A total of 435 DBE were performed at our institution during the 24-months study period. Sixty-five patients (14.9%) with post-obesity surgery were evaluated using DBE. The types of surgery were: RYGB, gastric sleeve, lap-band. The indications for DBE was obscure GI bleeding (OGIB) (nz18), ERCP (nz31), and evaluation of and abdominal pain or diarrhea (nz10) and placement of direct feeding jejunostomy (nz6). The excluded stomach could be reached in 87% of patients with Roux-en Y gastric bypass. The overall diagnostic yield of DBE-ERCP was 68% (stones, nz7, sphincter stenosis, nz6, bile leak, nz4, bile duct stricture, nz4, failed ERCP, nz10). The yield of DBE for abdominal pain was 40% (nz4: gastric erosions, gastro-gastric fistula, anastomotic stricture and erosions) and DBE for obscure GI bleeding (61%). Of the 18 patients with OGIB, 10 had active or a source of bleeding at the time of DBE. In all but one case, the bleeding was occurring at the site of the anastomosis, (hepaticojejunal, jejunojejunal, or gastrojejunal anastomosis). Of these patients 4 patients had arteriovenous malformations at the anastomotic site, 5 had ulcers or erosions, and 2 were bleeding secondary to Dieulafoy s lesions. A total of one complication (3%) was observed (small bowel perforation after application of argon plasma coagulation to the jejunojejunal anastomosis). One patient had actively bleeding duodenal ulcer at the excluded bulb, which was treated with injection and clip. Conclusions: DBE is a feasible and relatively safe technique to evaluate the small intestines, stomach and biliary tract and associated with reasonably high diagnostic and therapeutic yield in patients with surgically altered bowel anatomy in the setting of bariatric surgery. Mo1567 Percutaneous Endoscopic Gastrostomy by Single Balloon Enteroscopy in Patients Who Have Undergone Roux-EN-Y Gastric Bypass Frank C. Kurzynske*, Andrew Brock MUSC, Mount Pleasant, SC Background: Percutaneous endoscopic gastrostomy (PEG) provides a method of administering nutrition to patients unable to take food by mouth. Roux-en-Y gastric bypass (RNY-GB) anatomy precludes PEG placement using standard endoscopes. Traditionally, surgical or interventional radiology techniques are used in these patients. Only one small case series exists of PEG placement by deep enteroscopy (double balloon) in this population, but none by single balloon enteroscopy (SBE). Aim: Evaluate the efficacy and safety of PEG placement by SBE in patients with RNY-GB anatomy. Methods: We conducted a retrospective analysis of all PEGs placed in patients who have undergone RNY-GB by SBE performed at the Medical University of South Carolina from July 2011-July Variables collected included: demographic information, PEG indication, technical success of PEG placement by SBE, reasons for failure, SBE PEG alternatives in setting of placement failure, and adverse events. Results: 23 patients met inclusion criteria. 91% were female and 74% Caucasian. Mean age was % of procedures were done as inpatient. Procedural indications included malnutrition (14), nausea and vomiting (3), dysphagia (3), weight loss (1), anastomotic ulcer (1), and failure to thrive (1). Technical success of reaching excluded stomach was 70% (16/23). PEG placement was successful in 48% (11/23) of patients. Reasons for PEG placement failure included lack of 1:1 palpation/transillumination (5), long Roux/afferent limb (4), refractory looping (2), and adhesions (1). Failed SBE PEG treatment alternatives included continued oral intake (4), surgical G/J tube placement (4), continued NG usage (2), and IR PEG placement (2) (Table 1). The only adverse event was a case of PEG site cellulitis. Conclusion: PEG placement by single balloon enteroscopy is safe when able to be placed in patients with Roux-en-Y gastric bypass. Reliably reaching the excluded stomach and finding an appropriate window for PEG placement pose challenges to high success rates. Characteristics and results of SBE PEG placement in 23 patients Procedure indication: no. (%) Malnutrition 14 (61) Nausea & Vomiting 3 (13) Dysphagia 3 (13) Weight loss 1 (4) Failure to Thrive 1 (4) Marginal ulcer 1 (4) Technical success of reaching excluded stomach: no. (%) 16 (70) PEG placement: no. (%) Yes 11 (48) No 12 (52) Causes of PEG placement failure: no. (%) Lack of 1:1 palpation or transillumination 5 (42) Long Roux/afferent limb 4 (33) Refractory looping 2 (17) Adhesions 1 (8) Failed SBE PEG treatment alternatives: no. (%) Continued oral intake 4 (33) Surgical G/J tube placement 4 (33) Continued NG tube usage 2 (17) Interventional radiology PEG placement 2 (17) Mo1568 New Technique of Balloon-Overtube- and Fluoroscopy-Assisted Direct Percutaneous Endoscopic Jejunostomy in Patients With Surgically Altered Upper GI Tract Anatomy Ivan Jovanovic*, Paul T. Kroner, Kondal R. Kyanam Kabir Baig, Mark C. Phillips, Shajan Peter, Monkemuller Klaus Basil I. Hirschowitz Endoscopic Center of Excellence, University of Alabama, Birmingham, AL Introduction: Experience using direct percutaneous endoscopic jejunostomy (DPEJ) in patients with surgically altered upper gastrointestinal (GI) tract anatomy is limited to case reports and small series. By using the pull-through method of jejunostomy placement perforation of the small bowel at the various anastomoses or strictures may occur. The present study describes a new method of DPEJ in patients with surgically-altered upper GI tract. Aims: To report on the efficacy and safety of a novel overtube- and fluoroscopy-assisted DPEJ technique in patients with surgically deranged upper GI tract anatomy. Methods: This was an observational, retrospective, single-arm study conducted at a tertiary care hospital during an 24-month period. Technique: Deep enteroscopy was performed by using the standard pushpull-technique with the patient under general anesthesia and in supine position. Careful attention was paid to clearly define the efferent jejunal limb. The new DPEJ technique focuses on three key components: (i) use of balloon-assisted overtube; (ii) use of fluoroscopy; (iii) leaving the overtube in place during the entire procedure (and also for subsequent DPEJ removal). After a suitable site was identified, DPEJ placement was performed using the Ponsky-method (pull-type-percutaneous gastrostomy tube technique) using a 20 Fr PEG-kit. The overtube was left in place during the entire procedure, in order to safely allow for the passage of the PEG through the anastomoses, kinks and potential stenosis of the altered anatomy. Leaving the overtube in place also allowed for post-insertion inspection of the PEGbutton. Results: The study included 21 patients with complex post-surgical anatomy (11 females, 10 males, mean age 52 years, age range 28-78). In 12 patients previous endoscopic or radiologic attempts at providing enteral feedings had failed. The Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB469
75 patient s upper GI anatomy was the following: gastric bypass (nz4), Whipple s (nz4), Billroth II (nz5), Ivor-Lewis (nz3), gastric sleeve with leak (nz3), several anastomosis-undefined post-surgical status (nz2). The technical success was 90%. In two patients transillumination was not obtainable and placement failed. The mean distance of DPEJ was 70 cm (range 45 to 110 cm) past the gastrojejunal anastomosis. The mean procedure time was 35 minutes (range ). There were no major adverse events associated with the procedure. Conclusions: To the best of our knowledge this is the largest study using DPEJ in patients with complex surgically altered upper GI tract anatomy. The novel technique using overtube- and fluoroscopy was efficacious, safe and successful. Future comparative studies are now warranted Mo1569 Barrett s Esophagus After Sleeve Gastrectomy for Morbid Obesity: Preliminary Results Alfred Genco* 1, Emanuele Soricelli 1, Roberta Maselli 1, Giovanni Casella 1, Massimiliano Cipriano 1, Giovanni Baglio 2, Giuseppe Leone 1, Nicola Basso 1, Adriano Redler 1 1 Department of Surgical Sciences, Sapienza University of Rome, Rome, Italy; 2 Public Healthcare Agency of Lazio, Rome, Italy Introduction: Barrett s esophagus (BE) is present in!1-4% of patients. Sleeve gastrectomy (SG) has been shown to be effective in weight loss and DMTII, but its effect on gastroesophageal-reflux-disease (GERD) has been inconsistent. Objectives: We investigated whether GERD after SG could predict progression to BE in a prospective cohort of patients. These are the early results of a prospective ongoing evaluation. Methods: SG patients were called and an upper endoscopy (UE) was performed (Group-A). The control group (Group-B) was composed by obese patients, who did not undergo bariatric-procedures. GERD-symptoms, PPI therapy and BMI were collected. Biopsies of the Z line were taken. BE was histologically evaluated and compared between the groups. Results: Group-A was composed by 106 patients (mean follow-up 51 months, M/F 30/76, BMI at SG 47.3kg/m2, follow-up BMI 31.3kg/m2), while Group-B by 98 patients (M/F 87/11, BMI 43.5kg/m2).In Group-A and Group-B GERD symptoms were present in 66% and 55%. An intrathoracic sleeve migration was noted in 78%. LA-esophagitis percentage was: LA-B 18.8% and 22.5%, LA-C 37.7% and 0%, LA-D 22.6% and 0%, in GroupA and GroupB respectively. BE Histological diagnosis was 16.98% in Group-A and 0.98% in Group- B. Conclusion: Our results show that 80% of patients submitted to SG had a mild-tosevere esophagitis, not corresponding to reflux symptoms, and 16.9% of them had a histologically confirmed Barrett esophagus. Whether these results will be confirmed, SG should be considered a reflux-inducing bariatric procedure, a very close followup should be performed to avoid Barrett-related dysplasia progression and a modification in the surgical procedure should be considered Mo1570 Endoscopic Management of Upper GI Fistulae or Leaks: Exactly How Well Are WE Doing? Sami A. Almaskeen*, Atul Khanna, Laith H. Jamil, Kapil Gupta, Simon K. Lo Gastroenterology - Interventional Endoscopy, Cedars-Sinai Medical Center, Los Angeles, CA Background: Gastrointestinal perforation and fistulae are increasingly referred to GI interventionists for endoscopic treatment. These cases are typically difficult to manage, and the treatment options vary according to practice preference and individual experience. Aim: to examine our single center endoscopic experience in managing upper GI fistulae or leaks. Methods: Retrospective review of our records from 1/2012 to 11/2014. All upper endoscopies performed by our interventional GI group were reviewed individually through electronic medical records. Keywords in reports containing fistula, perforation, or leak would prompt further review to confirm appropriateness to include in this evaluation. All charts were traced to conclusions including death, definitive surgical intervention or successful complete closure. Results: 41 patients were identified. Fistulae or leaks were grouped by UGI regions: Esophagus (E)-11, Esophagogastric/esophagojejunal (EGJ)-7, gastric (G)-17, duodenal (D)-6. Seven patients are currently undergoing active treatment. Of 34 cases that had concluded their treatment courses, 10 (29.4%) had died; 6 (60%) of those deaths were felt to be the direct results of these fistulae or leaks. Duodenal leak was linked to high mortality (D-67%, E-57%, G-13%, EGJ-0%). 21/34 (61.7%) of completed cases had the defects successfully closed. Of the 4 location groups, EGJ defects seemed to have better outcome than the rest, although the difference did not reach statistical significance (Fisher s exact test pz0.06). In total, 149 endoscopic procedures were performed, with mean of 3.6 procedures per patient. There was no difference in the number of procedures per patient for each of the 4 groups (one way ANOVA, pz0.23). The median number of days taken to conclude treatment in those 34 patients was 74.5 days (7-585). It took a significantly longer time (165 days) to close EGJ leaks than those in E, G or D (75, 62.5 and 54 days. One way ANOVA, pz0.01). There was no difference in the number of days taken to complete the courses of treatment among the 4 groups (one way ANOVA, pz0.79). Clips, over-the-scope clip (OTSC), suture (started only recently) and stents were the 4 methods used to close the leaks. Effective closure was eventually achieved by OTSC in 5 and stents in 16 patients. The sizes of defects successfully closed by OTSC were all rated by endoscopists as small (%1 cm); those treated successfully by stenting included 5 defects rated as large. Conclusions: Upper GI leaks or fistulae carry high risks of mortality and prolonged morbidities. Endoscopic treatment is effective in closing 2/3 of these leaks, with stenting being the most effective modality. While EGJ leaks seem most favorable for endoscopic closure, they also require a significantly longer time to close than leaks in the other upper GI locations. Results of endoscopic treatment in 34 upper GI leaks that had completed their courses of treatment Location E EGJ G D P value Median # sessions to effective closure NS Median # days to completing treatment NS course (including deaths) Median # days to successful closure Deaths 4/7 (57%) 0/6 (0%) 2/15 (13%) 4/6 (67%) Mo1571 Endoscopic Treatment of Intragastric Migration of Laparoscopic Adjustable Gastric Banding. the Experience of a Spanish Non Tertiary Hospital Marisa Arias, Luis R. Rábago*, Luis Alonso, Castillo Herrera, Ana Olivares, Alejandro Ortega, Miguel Perez, Jaime Vazquez-Echarri Gastroenterology, Hospital Severo Ochoa, Leganes, Spain Introduction: The intragastric band migration is an uncommon complication of Laparoscopic Adjustable Gastric Banding (LAGB) (0.5-11%) usually resolved by surgical approach. We describe our experience of its successful endoscopic removal. Patients and Methods: Since 2001 we treated 127 morbid obese patients (pts) by LAGB. Those pts with migration of gastric band into stomach more than 50% of circumference were treated. The procedure was performed under general anesthesia with an standard gastroscope. We did not use fluoroscopy.first the band is cut using the cable from mechanical lithotripsy basket (MTW) or a standard inch guidewire. Second the wire is looped about the visible the band, grasped by the alligator forceps and brought out through the patient s mouth. Then the two ends of the wire are placed into the metal sheath of the mechanical lithotriptor (MTW) with progressively tightening about the band in order to cut it. The remaining external tubing and external port is now excised and removed by surgeon. Finally the split band is removed using a polypectomy snare. We did not use fluoroscopy. Results: We found that 11 out of 127 LAGB (8,6%) become symptomatic due to gastric migration. 88.8% were females with average of 42.6 yo. The time between the band placement and endoscopic removal was 60,5 months (29-120). The symptoms were epigastric pain and weight regain as a sign of band dysfunction.three pts were operated, one refused endoscopic treatment and the other were operated by band dysfunction finding out the gastric migration. 7 out of 9 LAGB (77.7%) were endoscopically removed in one session.we had two failures,1 out of 9 LAGB (11.1%) was not possible to cut and the other (11,1%) was split but not removed due to difficulties with ventilation by excessive gas insufflation. His recovery from the attempt was uneventful and she remains well after 7 years of follow up, waiting for their possible complete migration. No complications were noticed after the endoscopic removal and pts were discharged in average of 2,6 days(1-7). Mortality 0%. The band removal was accomplished in three steps: a) cutting the band of silicone in their middle part avoiding the plastic part near the external tube, b) seizing the end of the splitted band near the external tube, coming from the port and c) pulling the endoscope out steadily and forcefully to liberate the band from the gastric wall. Conclusions: More than 8,6% of LAGB will have gastric migration and develop symptoms.the endoscopic removal of LAGB is feasible, safe, but not easy, being a good alternative to surgery. We were able to remove 77,7% of LAGB, but the band should be migrated more than 50%. It is important to know very well the removal technique and their tricks. It is not necessary the use of intraoperative fluoroscopy and it seems to be safe to cut the band without their removal Mo1572 A Validated, Computerized Cleansing Score for Video Capsule Endoscopy Amir Klein* 1, Moshe Gizbar 3, Michael J. Bourke 1,2, Golo Ahlenstiel 1,2 1 Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, NSW, Australia; 2 University of Sydney, Sydney, NSW, Australia; 3, Sydney, NSW, Australia Background: Video capsule endoscopy (VCE) is a useful diagnostic tool for the investigation of small bowel (SB) pathology. The diagnostic yield (DY) of VCE, may be hampered by the presence of intestinal content or air bubbles. There is a lack of consensus regarding necessity of active bowel preparation and the optimal regimen. AB470 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
76 A major limitation in VCE related studies is the lack of a validated subjective score for bowel preparation quality. Aims: To design and validate a computerized SB preparation score for future research and clinical use. Methods: Two gastroenterologists, experienced in VCE reading and interpretation reviewed videos from our database and reached a consensus regarding adequacy of the bowel preparation. Overall, an image was considered inadequate (IA) if more than 50% of the mucosa was obscured by content or bubbles. VCE bowel preparation was determined to be IA if (1) a continuous segment of SB has IA preparation (more than 50% of obscured mucosa on individual images for more than 20 consecutive minutes) or if (2) the overall percentage of IA images exceeded 25% of the total video time. Cases were defined as borderline if consecutive minutes or overall 15%-25% of images were inadequate.to develop a computerized algorithm, the colour bar on the reading screen (RAPID 7 software, GIVEN imaging LTD) was used to analyse the bowel preparation level. All the areas on the colour bar where IA preparation was present were marked to create a computerized algorithm based on the pixels in each of the marked areas. Twenty videos were used as a training model to create the algorithm and fifty additional videos were then used for validation. The concordance between the gastroenterologists agreement (gold standard) and the computerized analysis was assessed. Results: Of the 50 capsules studied, 31 (60%), 3 (6%) and 19 (34%) had adequate, borderline and inadequate bowel preparation respectively according to the gastroenterologists agreement. When we restricted the analysis to A and IA cases the computer accurately classified the quality of the bowel preparation with a sensitivity of 90% and a specificity of 82% (total accuracy 88%). The Kappa coefficient between the computer and the physician s consensus was When adding the borderline definition, the computer accurately identified 2/3 of the borderline cases, yielding an overall Kappa coefficient of for the entire cohort. Conclusion: Using image analysis on the colour bar of the VCE screen we were able to create and validate a computerized cleansing score. When compared to the gold standard of agreement between two experienced readers the computerized score demonstrated excellent concordance. This computerized score holds promise as a standardization tool in the clinical practice of VCE. Further validation in a prospective manner is warranted. outcomes addressing the use of CE in the investigation and management of occult GI pathology in an effort to generate evidence-based algorithms and guidelines for its role in the workup of occult GI problems. Methods: A comprehensive search for clinical studies detailing the use of CE for multiple GI pathologies was conducted using Medline, PubMed, Google Scholar, and the Cochrane and NIH registry of clinical trials ( ). The search focused on CE s value in visualizing small bowel pathology and comparison to alternative diagnostic techniques. An analysis of indications, successes, and technical and clinical limitations of CE was performed. Meta-analysis was performed when at least 5 studies were available comparing CE to a single alternative diagnostic method. Keywords searched included, capsule endoscopy, push enteroscopy, retrograde ileoscopy, double balloon enteroscopy, small bowel imaging, Crohn s disease, occult gastrointestinal bleeding, and small bowel neoplasm in all possible combinations. Results: 47 studies involving 1,650 patients comparing CE with other diagnostic modalities were identified. 29 studies investigated occult GI bleeding (OGIB) in 1,178 patients, and the remaining 18 investigated Crohn s disease (CD) in 472 patients. CE provided the highest diagnostic yield when evaluating the small bowel for sources of OGIB (64%) and CD (67%). CE was significantly superior to push enteroscopy in identifying sources of OGIB (OR 4.529, p!0.001), and comparable to double-balloon enteroscopy (DBE) (OR 1.579, pz0.06). When evaluating for CD, the odds of identifying a pathologic lesion was significantly higher with CE than small bowel follow-through (OR 3.975, pz0.001), retrograde ileoscopy (OR 1.809, pz0.017), CT enterography (OR 2.927, pz0.045), and comparable to magnetic resonance enterography (MRE) (OR 1.452, pz0.218). MRE s main advantage over CE is its ability to evaluate extraintestinal lesions. CE has limitations in identifying small bowel neoplasms as it is inaccurate in estimating the number of polyps present and while it has a high sensitivity for small polyps (!15mm) larger polyps (O15mm) may be missed. Conclusion: CE is useful in visualizing the small bowel when conventional investigative methods are insufficient. CE has a well defined role in the work-up of OGIB, and an emerging place in investigating CD, and small bowel neoplasms. CE should be considered as a 3 rd or 4 th investigative procedure in the workup of occult GI enteropathies after upper and lower endoscopy, and done in concert with DBE and MRE as required. Mo1573 Clear Fluids Only and Sodium Picosulfate Are Effective and Better Tolerated Than 2L Polyethylene Glycol for Small Bowel Cleansing for Video Capsule Endoscopy: a Randomized Controlled Trial Lawrence Hookey*, Michelle Wiepjes, Natalie Rubinger, William G. Paterson, Jacob A. Louw Gastrointestinal Diseases Research Unit, Dept of Medicine, Queen s University, Kingston, ON, Canada Introduction: While the evidence for diagnostic yield and clinical effectiveness of capsule endoscopy is growing, there is still controversy regarding the type and amount of pre-capsule bowel cleansing required. Turbid fluid and food residue overlying the mucosa can make visualization difficult and lead to missed diagnoses. There is significant variability between studies in the type of preparation, dosage, time of administration, and in some, the use and type of a prokinetic. This randomized trial evaluated three strategies for cleansing the small bowel prior to video capsule endoscopy. Methods: Patients were recruited from outpatient gastroenterology clinics and had clinical indications for video capsule endoscopy (VCE). They were randomized to 1) clear fluids only the evening before VCE, 2) two sachets of sodium picosulfate plus magnesium sulfate the evening before, or 3) two liters of polyethylene glycol the evening before. Diet instructions were the same for all three groups. Small bowel cleansing was assessed in three ways: 1) a 5 point ordinal scale, 2) the percentage of time the small bowel was obscured more than 50% of the screen by material, and 3) a computerized assessment of cleansing. Results: 175 patients completed the trial, with 36% being male. The mean age was 49.2 years.tolerance: Significant differences were seen tolerance of the preparations with a higher proportion rating it as easy or very easy in the clear fluids only group (67%) and the sodium picosulfate group (67%) than in the 2L PEG group (13%) p! Efficacy: No significant differences were seen in bowel cleansing quality when assessed by 5 point rating scale, per cent time the view was obscured (pz0.16), or the computerized assessment of cleaning (pz0.11). There was no difference in diagnostic yield between groups. Discussion: Small bowel cleansing for video capsule endoscopy remains a controversial topic. This current randomized control trial demonstrates improved tolerance with minimally intense preparation (clear fluids only) without sacrifice of capsule visualization. Figure 1. Meta-analysis of the odds of identifying a source of occult gastrointestinal bleeding. (A) Capsule endoscopy (CE) vs. pushenteroscopy (PE); (B) CE vs. Double-balloon enterography (DBE). Mo1574 Capsule Endoscopy: a Solution to the Large Dilemma of Small Bowel Enteropathies? Varun Chakravorty* 1, Ronald S. Chamberlain 1,2 1 Surgery, St. Barnabas Medical Center, West Orange, NJ; 2 St. George s University School of Medicine, St. George s, Grenada Introduction: When and how capsule endoscopy (CE) should be utilized in the evaluation of occult gastrointestinal (GI) pathologies is ill defined and controversial. This meta-analysis and systematic review analyzes all published literature and clinical Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB471
77 total of 29 patients (33%) had at least one rebleeding episode but no differences were found between cases and controls(pz0.349). Nine patients died of nonanemia related causes and again there were no differences between groups(pz0.725). Conclusions: Red spots or mucosal erosions are commonly found in patients with iron-deficient anemia submitted to SBCE. The use of NSAIDs seems to be a risk factor for P1 lesions but the use of PPI was not protective. The bleeding potential of P1 lesions appears to be low, with patients having rebleeding rates comparable to those of patients with negative SBCE. As at long-term follow-up, about one third of patients will rebleed, further investigation and close monitoring seems appropriate. Figure 2. Meta-analysis of the odds of identifying a lesion consistent with Crohn s disease. (A) Capsule endoscopy (CE) vs. Small bowel followthrough (SBFT); (B) CE vs. retrograde ileoscopy; (C) CE vs. CT enterography (CTE); (D) CE vs. magnetic resonance enterography (MRE). Mo1575 Uncovering the Uncertainty: Risk Factors and Clinical Relevance of P1 Lesions on Small Bowel Capsule Endoscopy of Anemic Patients Tiago Cúrdia Gonçalves* 1, Mara Barbosa 1, Bruno Rosa 1, Maria J. Moreira 1, José Cotter 1,2 1 Gastroenterology Department, Centro Hospitalar do Alto Ave, Guimarães, Portugal; 2 Life and Health Sciences Research Institute, University of Minho, Braga/Guimarães, Portugal Background and Aims: Small bowel capsule endoscopy (SBCE) remains a crucial diagnostic instrument for the study of iron-deficiency anemia. Despite its high diagnostic yield, the clinical relevance and bleeding potential of findings such as red spots or mucosal erosions (P1 lesions) remain uncertain. This study aimed to identify risk factors for P1 lesions on SBCE and to describe the natural history of anemic patients with those lesions. Material and Methods: Retrospective analysis of 222 patients who consecutively underwent SBCE for the study of iron-deficiency anemia between September/2008 and August/2013. One hundred patients were selected for a case-control analysis performed between 37 cases with P1 lesions and 63 controls with negative SBCE. Age, gender, comorbidities (quantified by Charlson index) and regular medication were collected. Rebleeding, further investigational studies and death were also analyzed during the follow-up. Statistical analysis was performed using IBM SPSSv Results: From the analyzed patients, 75% were female and the median age was 58 years. No significant differences on gender(pz0.55), median age(pz0.609) or Charlson index(pz0.612) were found between cases and controls. Although no differences were found on the use of proton pump inhibitors (PPI)(pZ1.000), aspirin(pz0.051), anticoagulants(pz0.135) or antiplatelet agents(pz0.477), the use of NSAIDs was associated with a higher risk of P1 lesions found on SBCE of anemic patients (ORZ12.00, 95%CI ). Eighty-seven patients were followed at our center, with a median follow-up interval of 34 months. Thirty-nine patients (44,8%) were submitted to additional studies for investigation of anemia, and this was significantly more common in those patients with no findings on SBCE (53,7%vs.30,3%; pz0.033). A Mo1576 Predictive Model of Crohn s Disease Proximal Small Bowel Involvement in Capsule Endoscopy Evaluation Eduardo Rodrigues-Pinto* 1, Helder Cardoso 1, Bruno Rosa 2, João Santos-Antunes 1, Susana Rodrigues 1, Margarida Marques 1, Susana Lopes 1, Andreia Albuquerque 1, Pedro Carvalho 2, Maria J. Moreira 2, Jose Cotter 2, Guilherme Macedo 1 1 Gastroenterology, Centro Hospitalar São João, Porto, Portugal; 2 Gastroenterology, Centro Hospitalar do Alto Ave, Guimarães, Portugal Background & Aim: One of the indications for capsule endoscopy (CE) is the detection of proximal involvement of small bowel (SB) in Crohn s Disease (CD) patients. Our aim was to assess clinical, laboratory and endoscopic predictors significantly associated with lesions in proximal SB (first and second terciles) in patients with CD submitted to CE. Methods: A transversal and multicentric study was carried out in which Lewis score (LS) was systematically determined in 190 CE of patients diagnosed with CD between 2003 and Laboratory workup was analyzed at the date of diagnosis and the date of CE, and endoscopic findings closest to the date of CE were registered. Results: Of the 190 patients (57% female) that performed SBCE, most of the patients were diagnosed between 17 and 40 years old (A2-75 %), 43% had exclusively ileal involvement (L1), 75% had non-stenosing non-penetrating behaviour (B1) and 20% had perianal disease. Significant inflammatory activity (LSO135) was present in 23% of the patients in the first tercil and in 31% of the patients in the second tercil. Seventy-two percent of the patients had abdominal pain, 65% had diarrhea, 44% had weight loss, 11% rectal bleeding and 21% had extraintestinal manifestations. In the following 6 months after CE, 51% started corticosteroids, 20% started azathioprine, 14% started TB and 6% were submitted to surgery in the 16 months later. LS was higher in patients with lower haemoglobin levels (pz0.006), higher white blood cell counts (pz0.032), higher C-reactive protein (p!0.001), lower total protein levels (pz0.006), lower albumin levels (p!0.001). In the univariate analysis, a higher risk for proximal SB involvement at CE was associated with ileal involvement (OR 2.858, 95%CI: [ ], pz0.006), higher platelets levels (OR 1.005, 95%CI: [ ], pz0.004) and significant weight loss (OR 2.450, 95%CI [ ], pz0.006). An older age at diagnosis (O40 years) was associated with a trend toward protection for inflammatory activity at CE (OR 0.3, 95%CI: [ ], pz0.057). In logistic regression, ileal involvement at colonoscopy (OR 6.817, 95%CI: [ ], pz0.003), structuring behaviour (OR 8.653, 95%CI: [ ], pz0.011) and significant weight loss (OR 3.629, 95%CI: [ ], pz0.028) were independently associated with proximal SB involvement at CE. A cut-off higher than considering the ROC curve of this model was associated with 62% sensitivity and 75% specificity of proximal SB involvement (AUROC 0.732; 95%CI: [ ]). Conclusion: One third of patients had proximal SB involvement in this large cohort. Predictive factors for this involvement were significant weight loss, structuring behaviour and ileal involvement at colonoscopy. This data helps to select CD patients that benefit the most from performing a CE. Mo1577 Predictive Model of Small Bowel Disease Detected in Capsule Endoscopy in Patients With Established Crohn s Disease João Santos-Antunes* 1, Helder Cardoso 1, Bruno Rosa 2, Eduardo Rodrigues-Pinto 1, Susana Rodrigues 1, Margarida Marques 1, Susana Lopes 1, Andreia Albuquerque 1, Pedro Carvalho 2, Maria J. Moreira 2, José Cotter 2, Guilherme Macedo 1 1 Gastroenterology, Centro Hospitalar S. João, Porto, Portugal; 2 Centro Hospitalar do Alto Ave, Guimarães, Portugal Introduction: The role of Capsule Endoscopy (CE) in patients with established Crohn s Disease (CD) is not fully determined. Identification of predictive factors of small bowel disease may help the selection of patients that could benefit from CE. Aims and Methods: Evaluate whether clinical parameters, biomarkers, laboratory and endoscopic findings correlate with the presence of small bowel lesions in patients with CD. A transversal and multicentric study was carried out including patients with CD submitted to CE between 2003 and Data was analyzed using Pearson Chi-Square, Fischer s exact test, Mann-Whitney, Kruskal-Wallis and AB472 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
78 logistic regression as appropriate. Lewis score was calculated in all procedures. Results: One hundred and ninety patients with established CD were included, being 57% female. According to Montreal classification, 75% had diagnosis between 17 and 40 years-old (A2), 43% had ileal disease (L1) and the majority (75%) had non-stricturing non-penetrating disease (B1). Hemoglobin levels were significantly lower (pz0.006) in patients with higher Lewis score (O790) comparing with those with lower scores, although those differences were clinically insignificant (median 13.1 vs 13.9 g/dl). Similarly, albumin was lower (41 vs 45 mg/dl, p! 0.001) and C-Reactive Protein was higher (7.65 vs 3.40 mg/l, p!0.001) in patients with Lewis score higher than 790. The presence of small bowel disease diagnosed by CE was significantly related with the need of steroids in the first 6 months after diagnosis (OR 3.088; CI 95% ), the presence of ileal disease at colonoscopy (OR 4.680; CI 95% ) and history of weight loss (OR 2.763; CI 95% ). Albumin levels were inversely related to the presence of small bowel disease (OR 0.843; CI 95% ). Multivariate logistic regression showed that albumin levels (OR 0.745; CI 95% ) and ileal disease (OR ; CI 95% ) were independently related to small bowel disease (AUROCZ0.806 ( ), with a sensitivity and specificity of 79% with a cutoff of 0.77). Disease behaviour, early need of azathioprine or biologics, C-reactive protein levels, hemoglobin, abdominal pain and diarrhea were not predictive of small bowel disease. Conclusion: Predictive factors for small bowel disease diagnosed at CE in patients with CD include early need of steroids, ileal disease at colonoscopy, weight loss and lower albumin levels. Regarding those with positive findings at CE, lower hemoglobin and albumin levels and higher C-reactive protein were related with more serious disease. This data may help the selection of patients with CD in which CE could be more useful. Mo1578 Usefulness of Evaluating Small Intestinal Mucosa With Capsule Endoscopy in Clinically Inactive Crohn s Disease Toru Yoshimura* 1, Osamu Watanabe 1, Masanao Nakamura 1, Takeshi Yamamura 2, Kazuhiro Morise 1, Asuka Nagura 2, Masanobu Matsushita 1, Arihiro Nakano 1, Hiroshi Oshima 1, Junichi Sato 1, Yasuaki Ueno 1, Masashi Saito 1, Rinzaburo Matsuura 1, Yasuyuki Mizutani 1, Kazuhiro Furukawa 1, Kohei Funasaka 2, Eizaburo Ohno 1, Ryoji Miyahara 1, Hiroki Kawashima 1, Yoshiki Hirooka 2, Takafumi Ando 1, Naoki Ohmiya 3, Hidemi Goto 1,2 1 Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya-shi, Japan; 2 Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan; 3 Department of Gastroenterology, Fujita University, School of Medicine, Nagoya, Japan Background: In Japan, patency capsule (PC) was approved on July Using PC, Capsule Endoscopy (CE) enables non-invasive visualization of small intestine in Crohn s disease (CD). CD patients can be managed according to CE findings in addition to symptoms and laboratory findings. Aims: We aimed to examine the usefulness of evaluating small intestinal mucosa with CE in CD. Methods: Medical records of consecutive CD patients who were proven patent with PC and underwent CE in Nagoya University Hospital from January 2010 to June 2014 were retrospectively reviewed. We examined the relation between CE findings which was quantified using the Lewis score (LS) and symptoms or laboratory findings. Results: Of 75 patients undergoing PC test, 61 patients were proven patent and underwent CE. The characteristics of 61 patients undergoing CE included: 37 males, mean age years, median disease duration 83 months, disease location: ileal 28, ileocolonic 28, colonic 5, median CDAI 74 (6-241). 67.2% of patients had ulcerative lesions in small intestine and median LS was 225 (0-4728). There were only weak correlations between LS and C-reactive protein (CRP) levels (rz0.31, pz0.02), albumin levels (rz-0.30, pz0.02) or CDAI (rz0.28, pz0.03). But scatter diagrams showed that there was inflammation in small intestine in 55% of patients with normal CRP levels, 57% of those with normal albumin levels and 66% of those in clinical remission on CDAI (Figure 1). The treatment was modified based on the positive CE findings in 34.4% of patients undergoing CE, 51.2% of those with LS S 135, 31.9% of those in clinical remission on CDAI, 28.9% of those with normal CRP levels and 25.7% of those with normal albumin levels. Conclusion: CE could detect the small intestinal lesions which could not be pointed out by symptoms or laboratory findings such as CRP or albumin levels. CE is useful for the detection of small intestinal lesions in clinically inactive CD. Clinically inactive CD patients should also be submitted to CE. Figure 1. Scatter diagrams of LS and CRP or CDAI Mo1579 Novel Diagnostic Findings on Capsule Endoscopy in the Small Bowel of Patients With Crohn s Disease Kenji Watanabe* 1,2, Atsushi Noguchi 2, Takako Miyazaki 3, Kenichi Morimoto 2, Shuhei Hosomi 2, Tomomi Yukawa 2, Noriko Kamata 2, Hirokazu Yamagami 2, Kazunari Tominaga 2, Toshio Watanabe 2, Yasuhiro Fujiwara 2, Shiro Nakamura 3, Hiroko Nebiki 1, Tetsuo Arakawa 2 1 Gastroenterology, Osaka City General Hospital, Osaka, Japan; 2 Gastroenterology, Osaka City University, Osaka, Japan; 3 Inflammatory Bowel Disease, Hyogo College of Medicine, Nishinomiya, Japan Background: Definitive diagnosis for Crohn s disease (CD) at an early stage can optimize treatment strategy and can improve prognosis. However, thus far, no specific diagnostic criteria have been established based on the small bowel (SB) findings on capsule endoscopy (CE). In the present study, we aimed to identify and confirm the novel findings using CE in the SB of patients with CD. Subjects and Methods: We investigated the derivation cohort study and subsequently performed a prospective randomized study. The derivation cohort included 90 cases (cases with established ileitis or ileocolitis CD [nz52], suspected CD [nz8], intestinal Behçet s disease [nz5], and infectious enteritis [nz5], and users of non-steroid anti-inflammatory drug [NSAIDs; nz13] and aspirin [nz7]). Thereafter, we conducted a prospective randomized controlled study to confirm the specific CE findings (UMIN ). Three investigators were trained to observe specific findings from among the CE videos; these investigators were then blinded to the clinical backgrounds of patients included in the prospective randomized study, and assessed the CE videos of the patients. Results: In the derivation cohort, the specific CE findings were determined for 51 CD cases (85.0%). These novel findings included the transition from aphthae to erosion, as well as to small or longitudinal ulcers, as the capsule endoscope progressed towards the distal portion of the SB. These transition of the small bowel lesion (TSL) in patients with CD was observed significantly more frequently in patients with CD than in patients with other diseases (1 of 30 cases, 3.3%: P!0.01). Our prospective randomized controlled study included 20 patients with established ileitis or ileocolitis CD and 20 patients with long-term NSAIDs or aspirin users (11 NSAIDs, 5 aspirin, and 4 both; the control group). All 40 patients were tested for functional patency of the gastrointestinal tract using a patency capsule, of which 14 were confirmed in each group. TSL was accurately diagnosed in 12 of 14 CD patients (85.7%) and was accurately diagnosed in 1 in 14 NSAIDs or aspirin users (7.1%: PZ0.02); the difference in the diagnostic accuracy rate was statistically significant. TSL was provided high availability (specificity 85.7%, sensitivity 92.9%, positive predictive value 92.3%, and negative predictive value 86.7%). Conclusion: TSL is a novel CE finding in SB lesions in CD patients. TSL can be used in the differential diagnosis between CD and other inflammatory bowel diseases in patients with limited distribution of such lesions in the SB during the early stages. Early diagnosis and appropriate optimized treatment may improve prognosis in patients with CD of the SB. Mo1580 Prediction of Patency Capsule Retention by MR Enterography in Patients With Known Crohn s Disease: Michal Marianne Amitai 2, Noa Rozendorn 2, Eyal Klang 2, Adi Lahat 1, Doron Yablecovitch 1, Uri Kopylov* 1, Shomron Ben-Horin 1, Abraham R. Eliakim 1 1 Gastroenterology, Sheba Medical Center, Ramat Gan, Israel; 2 Diagnostic imaging, Sheba Medical Center, Ramat Gan, Israel Purpose: The main complication of capsule endoscopy (CE) in Crohn s disease (CD) patients is capsule retention. Evaluation of small bowel patency is recommended before CE administration by using cross-sectional imaging or patency capsule (PC). Our aim was to evaluate the ability of magnetic resonance enterography (MRE) to predict PC retention in CD patients, and to identify the most predictive imaging features for PC retention. Methods: Fifty seven patients underwent MRE followed by PC. A radiologist blinded to the PC results gave a positive or negative prediction for PC retention based on the MRE nd thereafter all Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB473
79 patients swallowed a PC. Diseased segments (DS) on the MRE were evaluated for the following imaging features: mean number of segments, stenosis and prestenotic dilatations, maximal stenosis length, maximal wall thickness and presence of enhancement.the association of these imaging features with the risk of PC retention was evaluated. Results: The radiologist gave a positive prediction of PC retention in 30/57 patients. Actual PC retention occurred in 13/57 patients and was predicted by MRE in 12/13 cases. The sensitivity, specificity, positive and negative predictive values (PPV/NPV) for prediction of PC retention were 92.3%, 59%, 40% and 96.3% respectively.diseased segments were found in 45 /57 patients. The mean maximal stenosis length (9.7 cm vs 7 cm, pz0.04) and the mean number of prestenotic dilatations (2 vs 1.1, pz0.02) were significantly associated with PC retention. One case of symptomatic PC retention occurred in the study which resolved with steroid treatment. No cases of CE retention occurred. Conclusion: MRE has high NPV and sensitivity but low PPV and specificity for PC retention.capsule retention suggested by MRE should not preclude performance of PC to determine the feasibility and safety of diagnostic CE. Longer stenosed strictures and higher number of prestenotic dilatations on MRE were significantly associated with PC retention.re, SBH-equal contribution Funded by the Helmsley Charitable Fund Mo1581 Evaluation Method of Lesions in Small Bowel in Patients With Crohn s Disease With Preliminary Examination With Patency Capsule Sadaharu Nouda*, Takuya Inoue, Naoki Yorifuji, Munetaka Iguchi, Kazuhiro Ota, Kaori Fujiwara, Shoko Edogawa, Yuichi Kojima, Ken Narabayashi, Toshihiko Okada, Kazuki Kakimoto, Ken Kawakami, Yosuke Abe, Daisuke Masuda, Toshihisa Takeuchi, Kazuhide Higuchi 2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan Background and Aim: Small bowel capsule endoscopy (CE) enables observation of lesions in the small bowel in patients with Crohn s disease (CD). However, lesions in the small bowel cannot be assessed by CE in patients classified as patency not confirmed. Therefore, we evaluated the usefulness of a method to assess lesions in the small bowel in patients with CD who had preliminarily undergone examination using a patency capsule. Methods: The subjects were 50 patients who underwent examination using a patency capsule between July 2012 and September 2014 because of CD with lesions in the small bowel. First, all patients underwent examination using a patency capsule. Then, patients classified as patency not confirmed based on the results of the examination underwent enteroclysis for assessment of lesions in the small bowel, and patients classified as patency confirmed underwent CE. The following two issues were examined: 1) correlation between the LS (Lewis score) (LS) and blood data (leukocytes, hemoglobin, platelets, C-reactive protein [CRP] ) and that between the LS and Crohn s disease activity index (CDAI), and 2) analysis of the LS in patients with clinical remission defined as CDAI! 150. Results: The patients baseline characteristics were as follows: 39 (78%) were men, age ranging range from 16 to 72 years (mean: 35.2 years) in age, with and a disease duration of 0 to 45 years (mean: 9.5 years); 17 (34%) had small-bowel type and 33 (66%) had small-and-large-bowel type CD; CDAI were was 10 to 329 (mean: 108.9). (1) Seven patients were classified as patency not confirmed. Enteroclysis in these patients revealed a stricture due to active lesions at the site corresponding to that of retention of the patency capsule identified by abdominal radiography in six of the patients, as well as narrowing of the anastomotic site without any active lesions in the remaining one patient. (2) Forty-three patients were classified as patency confirmed and underwent CE. None of these patients had retention of the patency capsule. The results of CE indicated that the number of ulcers was (mean SD), and the LS was (mean SD). Assessment of the correlation between the LS and blood data or CDAI revealed a significantly positive correlations between the LS and CRP (CRP; r Z 0.49, P! 0.01). There were 29 patients with a CDAI! 150, of whom. Of these, 17 (58.6 %) had an LS O 135, athe value defined as indicative of inflammatory activity. Conclusions: Patency capsules can be used not only to assess the patency of the small bowel, but also to indicate the location of a lesion during enteroclysis. In addition, since clinical remission is not always associated with endoscopic remission, CE is also useful in patients with CD. Mo1582 Capsule Endoscopy: Diagnostic Accuracy of Lewis Score in Patients With Suspected Crohn s Disease Sara Monteiro* 1, Pedro Boal Carvalho 1, Francisca Dias De Castro 1, Joana Magalhães 1, J. Firmino-Machado 2, Maria João Moreira 1, Bruno Rosa 1, José Cotter 1,3 1 Gastroenterology, Alto Ave Hospital Center, Guimarães, Portugal; 2 Alto Ave Hospital Center, Guimarães, Portugal; 3 Life and Health Sciences Research Institute (ICVS), School of Health Sciences, University of Minho, Braga, Portugal Introduction: Small bowel capsule endoscopy (SBCE) has assumed an increasing importance in the diagnosis of Crohn s Disease (CD). The Lewis Score (LS) aims to standardize the method of quantification of small bowel inflammatory activity detected by the capsule. Aims & Methods: The aim of this study was to evaluate the diagnostic accuracy of the LS in patients with suspected CD undergoing SBCE. We performed a retrospective single-center study including 95 consecutive patients who underwent SBCE for suspected CD between September 2006 and February 2013, with at least 12 months of follow-up after the capsule. Patients were grouped according to the criteria of the International Conference on Capsule Endoscopy (ICCE) for the definition of suspected CD. Group 1: 37 patients not fulfilling the minimum requisite of 2 ICCE criteria; Group 2: 58 patients with R 2 ICCE criteria. Inflammatory activity on SBCE was objectively assessed by determining the LS. The confirmation of the diagnosis of CD during follow-up was based on a combination of clinical, analytical, endoscopic, histological and imaging elements. Results: SBCE detected significant inflammatory activity (LS R 135) in 46 patients (48.4%), 7 patients from Group 1 (18.9%) and 39 patients from Group 2 (67.2%) (p! 0.001).The diagnosis of CD was established during the follow-up in 38 patients (40%): 8 patients (21.6%) from Group 1, 30 patients from Group 2 (51.7%) (p Z 0.003). Among those patients with confirmed diagnosis of CD on follow-up, 34 patients had LS R 135 (73.9%) and 4 patients had LS! 135 (8.2%) at SBCE (p! 0.001). The LS R 135 had an overall diagnostic accuracy of 83.2 % with a Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value for the diagnosis of CD were 89.5%, 78.9%, 73.9% and 91.8%, respectively. Conclusion: The application of LS R 135 as the cut-off value for the presence of significant inflammatory activity in patients undergoing SBCE for suspected CD may be useful to establish the diagnosis in patients with high pretest probability of CD based on an adequate clinical context as defined by the ICCE. In patients with LS! 135, the probability of having CD confirmed on followup is low. Mo1583 Clinical Evaluation of Crohn s Disease in Remission by Capsule Endoscopy Tomoki Hiramoto*, Chiyuki Watanabe, Yuko Hiraga, Masaaki Sumioka Endoscopy, Hiroshima prefectual Hospital, Hiroshima, Japan Background: In patients with quiescent Crohn s disease (CD), mucosal healing may not be endoscopically achieved, which often leads to exacerbation of symptoms during follow up. Capsule endoscopy (CE) has been contraindicated in Japan for CD due to the risk of retention at strictures of small intestinal lesions. However, the use of patency capsule (PC) to verify patency of the intestinal tract has allowed CE to be performed for CD since July [Objective] We performed CE after the PC procedure to observe the small intestinal mucosa in patients with quiescent CD and a patent intestinal tract as confirmed by PC. The activity of small intestinal lesions was subsequently assessed on the basis of CE findings, and the efficacy of CE was evaluated to assess clinical outcomes. Subjects and Methods: A total of 33 patients with quiescent CD who underwent the PC procedure and who could be followed up for 6 months or more (25 males, 8 females; average age, 36.2 years) were included. Clinical remission was defined as a CD activity index (CDAI) of! 150. CE was performed in patients who were identified as having a patent intestinal tract by the PC procedure, and active lesions were judged on the basis of CE findings of at least one small ulcer. Patients were followed up for 6 months or more after the PC procedure, and changes in the clinical activity were assessed by comparisons of the estimated CDAI score. We examined associations between CE findings and biomarkers of activity, such as C-reactive protein (CRP) and fecal occult blood. We observed the clinical course for more than 6 months after CE and evaluated clinical activity changes on the basis of CE findings. Results: Among 33 patients who underwent the PC procedure, 22 patients (66.7%) were determined to have a patent small intestinal tract and subsequently underwent CE. In eight of these patients (36.4%), active lesions in the small intestine were detected by CE. The presence of active lesions showed no correlation with CDAI scores, CRP levels, or fecal occult blood. Among eight patients with active lesions, three (37.5%) experienced worsening from clinical remission to the active phase within 6 months. On the other hand, 14 patients without active lesions detected by CE remained in clinical remission. Conclusion: In 36.4% of patients with quiescent CD with a patent intestinal tract, active lesions in the small intestine were detected by CE. CE findings were not entirely consistent with CDAI scores, CRP levels, and fecal occult blood. In three (37.5%) of eight patients with active lesions identified by CE, the clinical condition deteriorated within 6 months after the PC procedure, whereas clinical remission was maintained in patients in whom no active lesions had been identified. These findings suggest that CE is a useful examination to predict clinical prognosis of patients with quiescent CD. AB474 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
80 Mo1584 Differentiating Small Intestinal Crohn s Disease From Intestinal Tuberculosis: Can Capsule Endoscopy Help? Surinder S. Rana*, Vishal Sharma, Deepak K. Bhasin Post Graduate Institute of Medical Education & Research, Chandigarh, India Background: Differentiation of intestinal tuberculosis (ITB) from Crohn s Disease (CD) is an important diagnostic challenge. Capsule endoscopy (CE) can effectively diagnose subtle small intestinal (SI) lesions missed by other modalities. CD may involve large areas of gastrointestinal tract whereas ITB is usually characterised by limited small bowel involvement and therefore we hypothesised that CE may be able to differentiate between CD and ITB by evaluating the extent of involvement of SI. Objective: Prospectively evaluate utility of small bowel CE in differentiating CD from ITB. Methods: Patients with suspected ITB or CD with terminal ileal involvement on ileocolonoscopy were prospectively enrolled. After confirming the patency of the gastrointestinal tract by ingestion and subsequent passage of patency capsule or by Barium enteroclysis or CT Enterography, the patients underwent CE. Results: Thirty two patients (20M; age range: years) with ITB and 20 patients (14M; age range years) with CD were prospectively studied.the patency of gastrointestinal tract was confirmed with patency capsule in 16 patients with CD and 9 patients with ITB respectively. Remaining patients underwent barium enteroclysis or CT Enterography prior to CE. The patency capsule did not pass out in 2 patients with CD and 4 patients with ITB. Sixteen patients with ITB had a tight stricture on radiological evaluation and 4 patients had confirmatory histopathology with presence of acid fast bacilli (AFB) and therefore CE was not done in these 20 patients. After exclusion, CE was done in 18 patients with CD and 8 patients with ITB respectively. Complete examination was possible in all patients with ITB and 15 (83%) patients with CD. All patients with ITB had terminal ileal involvement along with involvement of ileocecal area in the form of ulceration and nodularity. Six patients had large ulcers and two had aphthous ulcers. Rest small bowel was normal. All patients with CD also had terminal ileal involvement but ileocecal valve involvement was seen in 5 (27.7%) patients. Large ulcers were observed in 7 (39%) patients and aphthous ulcers were observed in 15 (83%) patients. Jejunal involvement as aphthous ulcers and nodularity was seen 4 (22%) and 1 (5%) patients respectively. On comparison with CD, patients with ITB had increased frequency of ileocecal valve involvement (pz0.001) and lesser frequency of aphthous ulcers (pz0.007). Asymptomatic involvement of other segments of small bowel was observed in one third of patients with CD in contrast to none of the patients with ITB. Conclusion: CE can help in differentiating CD from ITB with ileocecal valve involvement being more common in ITB and aphthous ulcers as well as multi-segment involvement of small bowel being seen more frequently in CD. Mo1586 Assessment Tool to Evaluate Competency of Capsule Endoscopy Pre-Reader Tamotsu Sagawa* 1, Hidetoshi Ohta 2, Yasushi Sato 3, Yasuhiro Sato 1, Tsuyoshi Hayashi 3, Tokiko Nakamura 1, Koshi Fujikawa 1, Yasuo Takahashi 1 1 Division of Gastroenterology, National Hospital Organization HOKKAIDO Cancer Center, Sapporo, Japan; 2 Division of Gastroenterology, Sapporo Orthopedics and Cardiovascular Hospital, Sapporo, Japan; 3 Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan Background: Capsule endoscopy (CE) has become an important tool for the diagnosis of small bowel disease. A major problem of CE is that it is time consuming to read one case. One way to overcome this issue is interpretation support by CE Pre-Readers. However, the quality assurance and quality control of the CE procedure can be difficult to maintain, if CE data are not interpreted by qualified Pre- Readers. On the other hand, there is no validated assessment tool to evaluate CE competency. Aim: The aim of this study was to evaluate by Pre-Reader Assessment Form whether, following adequate training, Pre-Readers are capable of detecting all significant lesions without reducing the diagnostic accuracy of the procedure. Materials and Methods: We created a CE Pre-Reader Assessment Form with listings of potential findings in the small bowel. Before the study, trainees as Pre-Readers received education about RAPID Ò for PillCam Software. Pre-Readers were 3 endoscopy technicians who received a lecture on e-learning by JACE (The Japanese Association for Capsule Endoscopy) and 2 medical engineers who did not receive. The 15 educational cases including three categories (vascular lesions, ulcerative lesions, neoplastic lesions, each 5 cases) in this study were selected from our hospital. Pre- Readers reviewed 15 cases and completed the assessment form from January 2014 to March The physician reviewer (T.S.) individually reviewed as the gold standard and then evaluated the assessment form. Critique was provided on the same form, agreement, missed lesion, overcalled. Results: Agreement(A)/missed lesion(m)/ overcalled(o) were observed in 73.3%/22.7%/4.0%, respectively. A/M/O were 88.9%/ 11.1%/0% in endoscopy technicians, 50%/40%/10% in medical engineers. The diagnostic competency of endoscopy technicians who received a lecture on e-learning was superior to the diagnostic competency of medical engineers who did not receive. The agreement rate was high in vascular and ulcerative lesions. Even if trainees had received e-learning, it was difficult for them to accurately diagnose neoplastic lesions. Conclusion: In this study, we have demonstrated that Pre-Reader Assessment Form can be used to evaluate diagnostic competency of Pre-Readers. Our findings confirmed that endoscopy technicians, after an adequate training, was highly accurate in detecting the significant lesions. However, based on our results, feedback should be required for the improvement of diagnostic accuracy in neoplastic lesions. Mo1585 Role of Endoscopic Capsule in Patients With Chronic Diarrhea and Abdominal Pain of Unknown Origin Gladys Bravo Velez, Jesenia Ospina, Hannah P. Lukashok, Miguel Soria Alcívar, Carlos A. Robles-Jara, Raquel S. Del Valle, Carlos Robles-Medranda* Endoscopy, Ecuadorian Institute of Digestive Diseases, Guayaquil, Ecuador Introduction: Capsule endoscopy (CE) is a diagnostic method that enables visualization of intraluminal bowel, diagnosing disorders not diagnosed effectively. Objectives: To demonstrate the utility and diagnostic effectiveness of CE in patients with diarrhea and initially diagnosed and treated as irritable bowel syndrome and abdominal pain. Methods: Retrospective study ( / ) in patients who underwent CE for abdominal pain and / or diarrhea, normal studies: gastroscopy, colonoscopy and laboratory; patients without improvement, previously treated as IBS according to Rome III criteria. We used 2 type of capsules: Mirocam (Intromedic) and SB2 (Given-Imaging).Readings were performed by a single physician who is blinded for the study. Results: 216 CE were reveiwed. 65 (30%) subjects met the criteria. (35/65) or 53.8% were women. Median age was 50 years. Diarrhea was present in 33.8% (22/65) and abdominal pain in 66.1% (43/65). CE with diarrhea subjects showed: atrophy of the villi in 18.1% (4/22), and ulcers compatible with inflammatory bowel disease (IBD) 36.3% (n Z 8/22), normal study in 45.4% (n Z 10/22). CE in -abdominal pain subjects detected: ascaridiasis 2.3% (nz1/43), atrophy of villi in 23.2% (nz10/43), IBD in 25.5% (nz11/43), gastroparesis in 6.9% (n Z 3/ 43), submucosal tumor 2.3% (n Z 1/43), nonspecific erythema 4.65% (nz2).in total, the CE detected 48% more lesions that had a clinical impact of 100%. Conclusions: The CE showed an important role in managing IBS patients with no response to treatment. Mo1587 The Detection of Small Intestine Lesion Using PillCam SB3. -Has the Efficiency Been Achieved? Teppei Omori*, Tomoko Kuriyama, Ayumi Ito, Hiroyuki Konishi, Shinichi Nakamura, Keiko Shiratori Institute of gastroenterology, Tokyo women s medical university, Tokyo, Japan Objective: PillCam SB3 is characterized by the automatic conversion of the imaging frame rate and the improvement of the image resolution which are realized by using in combination with the DR3 recorder. In addition, it is considered that the efficiency of detection has been achieved by the improvement of the video processing function using in combination with the interpretation software RAPID Reader8. In this study, we calculated the interpretation time and the diagnostic contribution rate when using SB3 and examined the actual efficiency. Patients and Methods: A total of 64 patients who underwent small intestine capsule endoscopy performed at our hospital, were categorized into the following 2 groups: the SB2 plus group (30 patients) and the SB3 group (34 patients) to compare the gastrointestinal transit time, total testing time, interpretation time, number of the thumbnails, and diagnostic contribution rate of findings of each examination. RAPID Reader8 was used as the radiogram interpretation software for both groups. The interpretation time was defined as the time required from the start of the radiogram interpretation to the completion of the report. Result: There was no significant difference in the patient background between the two groups. The gastrointestinal transit time of the SB2 plus group vs. the SB3 group was as follows: the esophageal transit time: vs seconds, the stomach transit time: vs minutes, the small intestinal transit time: vs minutes, the large intestinal sojourn time: vs minutes, and the total testing time: vs minutes. There was no significant difference between the both groups. The interpretation time of the SB2 plus group vs. the SB3 group was minutes [95%CI: min.] and minutes [95%CI: min.], respectively, which indicated a significant reduction of the interpretation time in the SB3 group (p<0.0001). The number of the thumbnails in the SB2 plus group vs. the SB3 group was vs , which indicated no significance between the two groups (pz0.32). The diagnostic contribution rate of the SB2 plus group vs. the SB3 group was 56.7% vs. 79.4% (pz0.0625), which indicated a slightly Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB475
81 high tendency in the SB3 group but there was no significance between the two groups. Conclusion: When we used the RAPID Readar8 and the SB3/DR3 recorder, the interpretation time of the SB2 plus group vs. the SB3 group reduced significantly, but no decrease was observed in the number of the thumbnails and the diagnostic contribution rate. Therefore, we considered that the efficiency of the small intestine capsule endoscopy was achieved by the RAPID Readar8 and the SB3/ DR3 recorder, which realized the possibility of reducing the burden of radiogram interpretation. Mo1588 The New 360 Panoramic-Viewing Capsule Endoscopy System: Results of the First Multicenter, Observational, Study Gian Eugenio Tontini 1, Flaminia Cavallaro 1, Roberta Marino 4, Mark E. Mcalindon 7, Emanuele Rondonotti 3, Anastasios Koulaouzidis 6, Pasquale Vitagliano 5, Luca Pastorelli* 2,1, Maurizio Vecchi 2,1 1 Gastroenterology & Digestive Endoscopy Unit, IRCCS Policlinico San Donato, San Donato Milanese, Italy; 2 Department of Biomedical Sciences for Health, University of Milan, Milano, Italy; 3 Gastroenterology Unit, Ospedale Valduce, Como, Italy; 4 Gastroenterology and Digestive Endoscopy Unit, AO Lodi, Lodi, Italy; 5 Digestive Endoscopy Unit, AO Melegnano, Melegnano, Italy; 6 Gastroenterology and Digestive Endoscopy Unit, The Royal Infirmary of Edinburgh, Edinburgh, United Kingdom; 7 Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield, United Kingdom Background & Aims: CapsoCam Ò SV1 (CapsoVision Inc, Saratoga, USA) is a new small bowel capsule (SBC) with panoramic lateral view, wire-free technology, and long-lasting recording time. It is equipped with 4 high frame rate cameras (3-5 frames/second/camera), located at the side of the capsule. Previous studies, comparing this device with frontal view SBCs, showed comparable operative and diagnostic performance [Friedrich K, et al. J Gastroenterol Hepatol 2013; Pioche M, et al.endoscopy 2014]. We conducted a multicenter, observational study to assess the performance of CapsoCam Ò SV1 in real life clinical setting. Methods: Between January and November 2014, all consecutive patients undergoing SBC with CapsoCam Ò SV1 in four Italian and one British Institutions were enrolled. All the identified findings were classified according to their bleeding probability and clinical significance, in line with Saurin classification [Saurin JC, et al. Endoscopy 2003], as P0: low probability; P1: intermediate probability; P2: high probability. Patients were defined positive whether at least one P2 finding was identified in the video. Results: Fifty-nine patients underwent SBC (30 men; mean age SD: years, range: years). 48/59 were referred for obscure GI bleeding (OGIB: 11 with overt and 37 with occult GI bleeding) and 11/59 for suspected Crohn s disease (CD). No technical failure was recorded. 58/59 patients excreted and retrieved the capsule. One capsule was retained due to a neoplastic stricture, no acute obstruction occurred and retrieval was done at time of surgery. The overall diagnostic yield (rate of positive tests) was 42%, whereas it was 40% for OGIB and 55% for suspected CD. The ampulla of Vater was identified in 26 patients (27/59: 46%) and the capsule explored the entire small bowel in 93% of patients. In a per-lesion analysis, overall 217 findings were detected (P0: 27, P1: 93, P2: 97). Most of the lesions were located in the small bowel (186/217: 86%) and 51% of them were P2. Interestingly, 30/217 lesions (14%) were detected in the upper GI tract and ten of them were classified as P2; four patients with overt GI bleeding and one suspected for CD (5/59: 8%) had a positive test for lesions located in the upper GI tract. Conclusions: Our data suggest that, even when used in the everyday clinical practice, CapsoCam Ò SV1 have a detection rate and a safety profile at least equal to other SBC with frontal view. Mo1589 Role of Second-Generation Colon Capsule Endoscopy for Whole Gut Evaluation Cristiano Spada*, Cesare Hassan, Mariachiara Campanale, Lucio Petruzziello, Guido Costamagna Digestive Endoscopy Unit, Catholic University, Rome, Italy Background: although colon capsule endoscopy (CCE) was developed for evaluation of the colon, it can be used to assess the entire GI tract since it offers excellent images also of the esophagus and the small bowel (SB), with the exception of the stomach that remains poorly evaluated. Usually, after the firsts 3 min of running, CCE slows down the frame rate to 14 images/min. When SB is detected CCE automatically restarts using the Adaptive Frame Rate (AFR) technology. Nevertheless, CCE can be also activated to the AFR mode prior to the ingestion allowing the whole gut evaluation at a high frame rate acquisition. Aim of this preliminary, feasibility study was to evaluate the ability of CCE to evaluate esophagus, small bowel and colon if patients take CCE after early, manual activation. Methods: 19 pts (8F, mean age 58 yrs, R yrs) were enrolled. All pts underwent second-generation CCE. Pts were invited to follow the standard regimen of preparation for CCE. It consists of the regimen recommended by the ESGE guidelines with the inclusion of Gastrografin in adjunct to sodium phosphate booster. The day of the procedure all CCE were manually activated to AFR before the ingestion. Pts were asked to swallow CCE following the recommended procedure for ESO capsule. They remained in hospital until CCE transit into the SB was confirmed. They were, then, invited to drink the first booster and leave the hospital. Esophageal, SB and colonic transit times (TT) were evaluated. Esophagoscopy was defined complete when Z line was visualized. Completeness and cleansing level of SB and colon were evaluated. Significant findings were defined as findings that could explain the reason for referral and/or that had any effect on the medical decision making. Results: Indication for CE was: incomplete colonoscopy (nz7), OGIB (6), colonoscopy refusal (4), iron deficiency anemia (2). A total evaluation of the entire GI tract was possible in 14 out of 19 pts (74%): Z line was not visualized in 4 pts and colonoscopy was incomplete in 1. Overall the Z line was visualized in 15/19 (79%) pts. Mean esophageal capsule TT was 69 sec (R 5-497). 1 (5%) pt had esophagitis. Complete capsule enteroscopy and SB adequate cleansing level was achieved in all pts. Mean SBTT was 106 min (R38-231). Significant SB findings were diagnosed in 3 (16%) pts and included diverticula (1), ulcerations (1) and large bleeding polyp (1). Colon TT was 104 min (R ). CCE was complete and cleansing level was adequate in 18/19 (95%) pts. Significant findings were diagnosed in 6 (31%) pts: R6mm/R3 polyps (5) and caecal angiodysplasia (1). Conclusions: second-generation CCE is feasible for whole GI evaluation and it has a relevant impact on medical decision making. The indications for a pan-endoscopy, however, need to be clarified and the procedure should be validated. Mo1590 Utility of Flexible Spectral Imaging Colour Enhancement (FICE) for Small Bowel Video Capsule Endoscopy (VCE) Christian S. Jackson 2, Christina Chou 1, Lauren B. Gerson* 1 1 Gastroenterology, California Pacific Medical Center, San Francisco, CA; 2 Gastroenterology, Loma Linda VA Medical Center, Loma Linda, CA Background: Usage of Flexible Spectral Imaging Colour Enhancement (FICE) has been available for video capsule endoscopy (VCE) studies using the Given imaging platform. Some studies have suggested enhanced visualization of small bowel angiodysplasia (GIAD) and other findings with usage of FICE. Methods: We performed a systematic review of the medical literature in order to determine the efficacy of FICE for detection of GIAD and/or ulcerative lesions compared to standard VCE. We searched Pubmed ( ) and Cochrane systematic reviews using search terms including capsule endoscopy, image enhancement, ulcerations, and/or angiodysplasia. We included retrospective studies that described improvement in detection rates for GIAD and/or ulcerative lesions using FICE. We included findings reported only with FICE setting 1 (wavelength red 595 nm, green 540 nm, blue 535 nm) since FICE settings 2 and 3 were associated with lower diagnostic yields. We calculated pooled rates with 95% confidence intervals (CI) for detection rates using VCE compared to FICE 1. Odds ratios (OR) with 95% CI were calculated using random effects models when comparing diagnostic yields for VCE and FICE 1 for specific typesoffindings. For each analysis, FICE was selected as the gold standard for the determination of number of lesions detected. Comprehensive Meta-Analysis (CMA, Version 3, Biostat, Inc.) was used for the statistical analysis. Results: The literature search identified 9 relevant studies. The final analysis included three retrospective studies describing improvement in detection rates with FICE and three studies comparing diagnostic yields using standard viewing on VCE compared to FICE 1. Three studies were excluded for the following reasons: the first study did not detail diagnostic yields, the second paper did not detail total number of lesions found by VCE and/or FICE, and the third study only published sensitivity and specificity values.characteristics of the included studies are shown in Tables 1 and 2. When improvement in detection rates was the primary outcome measure of the analysis, data from 3 studies demonstrated pooled improvement rates of 87% (95% CI 72-95%) for the finding of GIAD, and 60% (95% CI 52-68%) for small bowel ulcerative lesions. Based on the data from 3 studies comparing VCE to FICE 1 for overall detection rates, the OR associated with utilization of FICE was 7.0 (95% CI 2-25, pz0.003) for detection of GIAD with significant heterogeneity present between studies (I 2 Z79%, pz0.0008). For detection of ulcerative lesions, the OR associated with usage of FICE compared to standard VCE was 2.6 (95% CI , pz0.0) without significant heterogeneity (I 2 Z0%, pz0.4) Publication bias was not evident for either analysis. Conclusions: Usage of FICE increases detection rates for small bowel GIAD and ulcerative lesions compared to standard VCE. Table 2. Detection Rate for Ulcerations/Erosions with FICE Author Year No. Ulcerations and/or Erosions Indication Ulceration on VCE Improved Detection rate with FICE 1 (%) Improved Detection rate with FICE 2 (%) Improved Detection Rate with FICE 3 Imagawa Various (125%) 54 (168%) 51 (159%) Sakai OGIB (75%) 60 (73%) 20 (24%) Sato Various (79%) 41 (98%) 24 (57%) VCEZvideo capsule endoscopy; OGIB Z obscure GI bleeding AB476 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
82 Mo1591 Usefulness of Flexible Spectral Imaging Color Enhancement (FICE) in the Evaluation of Subtle Small Bowel Ulcerative Mucosal Lesions Detected by Videocapsule Endoscopy Mihai Rimbas* 2, Lucian Negreanu 3, Lidia Ciobanu 4, Andreea Bengus 3, Cristiano Spada 1, Cristian Rasvan Baicus 3, Guido Costamagna 1 1 Digestive Endoscopy Unit, Catholic University, Rome, Italy; 2 Gastroenterology Department, Colentina Clinical Hospital, Bucharest, Romania; 3 Internal Medicine Department, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; 4 Regional Institute of Gastroenterology and Hepatology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania Background and Study Aims: Identification by videocapsule endoscopy (VCE) of subtle small bowel mucosal lesions can be challenging, as small differences in mucosal hue or pattern are difficult to detect. Chromoendoscopy virtual techniques based on narrowing the bandwidth of the conventional white light endoscopy image (WLI) were developed to better analyze the endoscopic image. However, data on the already implemented FICE (Flexible spectral Imaging Color Enhancement) software application for VCE are limited. Patients and Methods: in this multicenter study 250 difficult to interpret small bowel mucosal ulcerative lesions (selected as the least representative visualization of an unequivocally confirmed erosion from a succession of images, comprising small or shallow mucosal defects, erosions lacking a clear rim of erythema or located marginally in the field of view, or lesions with a poor image quality due to luminal content), and 50 artifact lesions mimicking ulcerative lesions selected from 64 VCE recordings in a previous prospective study (ClinicalTrials.gov ID NCT ) were evaluated by four experienced VCE readers in two steps, initially as WLI, then with the addition of all available chromoendoscopy pre-sets (FICE 1, 2, 3 and Blue mode), labeling them as real or faked and rating the usefulness of each of these pre-sets. The comparison of accuracies in correctly categorizing the images was performed between the two readings (McNemar s test). Results: Between the first (WLI only) and the second (chromoendoscopy-aided) reading, in terms of accuracy there was a global 16.5% [95% CI: %] improvement (p!0.001), derived from 22% [95% CI: %] improvement in the evaluation of true ulcerative images (p!0.001), and 11% [95% CI: %] decrease in the evaluation of faked ones (p Z 0.003), results reproduced for each of the four readers. FICE 1 and 2 pre-sets were rated as most useful. Conclusions: The use of FICE pre-sets 1 and 2 may be clinically meaningful in order to better categorize difficult to interpret small bowel mucosal ulcerative lesions. These pre-sets seem to provide a high level of visibility by transparent- izing opaque luminal content or enhancing the color differences associated with ulcerated mucosa. However, care must be taken, and individual images should only be evaluated as part of a succession in a recording, as the technology could also misguide the interpretation of artifacts as ulcerative lesions, extra caution being necessary under poor bowel preparation. Acknowledgement: The work has been funded by the Sectoral Operational Programme Human Resources Development of the Ministry of European Funds through the Financial Agreement POSDRU/159/1.5/ S/ Mo1592 Prospective Study of Narrow Band Imaging-Based Evaluation of Duodenal Villous Morphology in Patients With and Without Celiac Disease James H. Tabibian*, Jean Perrault, Joseph A. Murray, Konstantinos A. Papadakis, Christopher J. Gostout Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Rochester, MN Introduction: Duodenal mucosal biopsies are commonly requested in the workup of celiac disease, iron deficiency anemia, and other disorders, but a substantial proportion of these biopsies come back as histologically normal. Considering the financial burden of normal duodenal biopsies on a population level, a less invasive, cost-effective, and more strategic method for evaluating duodenal mucosa is needed. We therefore sought to examine the performance characteristics and clinical utility of narrow band imaging (NBI) in the evaluation of duodenal villous morphology. Methods: A pilot study was conducted in patients referred from August for upper endoscopy with duodenal biopsies for workup of celiac disease or other indications. Patients in whom duodenal biopsies were not obtained or age!18 years were excluded. Biopsies of the 2 nd portion of the duodenum were scored histologically (gold standard) as normal, partial villous atrophy, or complete villous atrophy by a staff pathologist masked to NBI findings. The performing staff endoscopist rated duodenal NBI findings in real-time using the same convention and obtained at least 2 NBI images for retrospective scoring by a therapeutic endoscopist and a gastroenterology fellow, both masked to clinical data. Performing staff, therapeutic endoscopist, and fellow NBI scores were compared pairwise to histology scores to calculate performance characteristics, and inter-rater agreement between was assessed using Cohen s kappa. Results: A total of 112 patients were recruited, among whom median age was 51 years (interquartile range 37-64). Referring indications included dyspepsia (47%) and nausea (23%), suspected celiac disease (14%), and known celiac disease on therapy (11%). Histologic scores were 94 (84%) normal, 12 (11%) partial atrophy, and 6 (5%) complete atrophy. Performing staff NBI scores were 79% normal, 14% partial atrophy, and 6% complete atrophy as compared to therapeutic endoscopist NBI scores of 91%, 5%, and 4% and fellow NBI scores of 70%, 24%, and 6%, respectively. As shown in Table 1, performance characteristics of NBI-based evaluation for distinguishing between normal and atrophic mucosa were favorable for all 3 raters; negative predictive value (NPV) was particularly high (92-100%). Agreement was moderate between staff endoscopist and therapeutic endoscopist (kz0.55), good between performing endoscopist and fellow (kz0.65), and fair between therapeutic endoscopist and fellow (kz0.37). Conclusions: NBI appears to be a promising tool for non-invasive evaluation of duodenal villous morphology. It can facilitate targeting of duodenal biopsies, and its high negative predictive value makes it especially useful in avoiding biopsies that are likely to reveal histologically normal mucosa. Therefore, use of NBI for this indication may result in improved diagnosis and/or cost savings. Table 1. Performance characteristics of NBI for distinguishing between normal mucosa and villous atrophy (partial or complete) as compared to histologic scores Sensitivity Specificity PPV NPV Accuracy Performing staff endoscopist 89% 93% 70% 98% 92% Therapeutic endoscopist 56% 100% 100% 92% 93% Gastroenterology fellow 100% 83% 53% 100% 86% Mo1593 Food Hypersensitivity in Patients With Urticaria and IBS Revealed by Confocal LASER Endomicroscopy: Appropriate Antigen Exclusion Diet Improves Both the Urticarial and IBS Symptoms Annette Fritscher-Ravens* 1, Marie J. Mösinger 1, Zino Ruchay 1, Mark Ellrichmann 1, Christoph Röcken 2, Jochen Brasch 3, Peter J. Milla 4 1 Internal Medicine I, Experimental Endoscopy, Kiel, Germany; 2 Pathology, University Hospital Kiel, Kiel, Germany; 3 Dermatology, University Hospital Kiel, Kiel, Germany; 4 Institute for Child Health, UCL, University Hospital London, London, United Kingdom Introduction: Urticaria is a transient skin condition, usually caused by an allergic reaction. Urticaria patients may also suffer from irritable bowel syndrome (IBS), a gastrointestinal disorder with poorly understood etiology. Functional imaging using confocal laser endomicroscopy (CLE) in the duodenum of IBS patients with suspected food intolerance may reveal reaction to food at a microscopic level. Urticaria patients who also have IBS may be food intolerant and could profit from exclusion of specific food antigens. Aim: To assess food intolerance in patients suffering from urticaria+ibs by CLE and evaluate improvement following antigen exclusion diet; to further evaluate whether histology and lavage for eosinophils, eosinophil catatone protein (ECT) and tryptase will reveal pathology. Methods: Patients with urticaria+ibs(urt+), and IBS alone(cle+), both reacting to food exposure on CLE with real-time increase of intraepithelial lymphocytes, epithelial breaks/gaps and fluorescein excretion, were followed up for IBS and urticaria improvement under exclusion diet of the reacting antigen for 1-2year(s). Duodenal biopsies and lavage from URT+, CLE+ and healthy controls (HC) were examined for mucosal eosinophils (mean of 10 high power fields(hpf)), ECP and a-tryptase from fluid immediately following food challenge. Results: 46 CLE+ (27 female, mean age: 46,714,4; 21-78years) and 10 URT+(6 male, mean age 50,2 +/- 17,2; 21-68years) were compared to 10 HC. All chosen CLE+ patients had marked reduction in symptoms (nz32, nz14 symptom free) after 6 months exclusion diet. 7/9 patients with additional urticaria reported a marked reduction of their skin lesions, in nz4 no skin lesion reappeared -2 years follow-up.eosinophils/10 HPF, from duodenal biopsies immediately after food exposure were lower in CLE+ vs HC and URT+ (1-32/ HPF, mean vs 2-18/HPF, mean ; URT 4-32/HPF, mean ); not statistically significant (pz0,35). Duodenal lavage from CLE+ and URT+ revealed higher ECP (!2-235 mcg/l, mean: and! 2-303mcg/l, mean ) when compared to HC(!2-13,1 mg/l mean ). URT+ ECP was statistically significantly higher (pz0.045;); ECP CLE+vs HC: ns. a-tryptase Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB477
83 was!1-31,7 mcg/l, mean ) in CLE+;! mcg/l, mean in URT+;!1-1.57mcg/l, mean in HC, which was not significant. Conclusions: Our results indicate that patients with urticaria+ibs may suffer from food intolerance and respond to exclusion diet. They display the same deficits as IBS patients without urticaria in mucosal barrier integrity, accompanied by a trend to increased eosinophils in duodenal biopsies in URT+ with significantly higher concentrations of ECP than HC, which suggest both IgE and non-ige mediated response in the urticarial patients. Larger studies are needed to confirm these small data. Mo1594 Usefulness of Probe-Based Confocal LASER Endomicroscopy in the Small Intestine During Double-Balloon Enteroscopy Naoki Ohmiya*, Tomomitsu Tahara, Mitsuo Nagasaka, Yoshihito Nakagawa, Tomoyuki Shibata, Ichiro Hirata Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan Background and Aims: Probe-based confocal laser endomicroscopy (pcle) enables real-time optical biopsy. Little is known about the microscopic in vivo pathology deep within the small bowel. Therefore, we determined the usefulness of pcle for various small bowel diseases during double-balloon enteroscopy (DBE). Methods: We performed pcle (Cellvizio) examinations during DBE after intravenous injection of Fluorescein in 16 patients with: Crohn s disease (nz3), malignant lymphoma (nz2; mantle cell lymphoma and follicular lymphoma), drug-induced injury (nz2; conventional nonsteroidal anti-inflammatory drug and aspirin), chronic non-specific multiple ulcers (nz2), intestinal lymphangiectasia (nz2: non-white villi type), angiodysplasia (nz2: 1 with hereditary hemorrhagic telangiectasia, 1 with solitary angiodysplasia), metastatic small bowel tumor (nz1), Peutz-Jeghers syndrome (PJS, nz1), and ischemic enteritis (nz1). Results: Approximately 40 seconds after intravenous injection of Fluorescein microcapillary vessels within the villi began to be enhanced, and minutes later epithelial cells were enhanced. In the 2 patients with malignant lymphoma, pcle demonstrated densely packed lymphoma cells sequestrated by capillary vessels within the lamina propria mucosae. In the patient with metastasis from cervical cancer, dark tumoral cells and suspected tumor vessels were observed. In the patient with PJS, hyperplastic nondysplastic mucosa was observed in PJ polyps. In patients with inflammatory diseases (Crohn s disease, drug-induced injury, and chronic non-specific multiple ulcers, and ischemic enteritis), hyperemic capillary vessels within the villi and shedding epithelial cells were observed in the mucosa around the erosion/ulcers. In 2 patients with non-white villi type intestinal lymphangiectasia, narrow dark vessels suspicious of lymphatic capillaries within the villi, and bold dark ducts suspicious of lymphatics in the submucosal layer were observed, accompanied by shedding epithelial cells. In 2 patients with angiodysplasias, numerous slightly dilated capillary vessels were anastomosed to each other in the villi. In the patient with hereditary hemorrhagic telangiectasia, mild similar findings were observed in the mucosa without angiodysplasias. Conclusions: pcle was useful for detection of lymphangiectasia in apparently normal mucosa in patients with non-white villi type intestinal lymphangiectasia, and was useful for microsopic detection of tumoral cells, angiodyslasias, and minute changes in various small bowel inflammatory diseases. Mo1595 Outcome of Capsule Endoscopy in Small Bowel Diseases: a Single Center Experience of 942 Capsule Endoscopy Procedures Over 11 Years Mahesh Goenka, Usha Goenka, Vijay K. Rai*, Mohd. Yasin Mujoo Institute of Gastrosciences, Apollo Gleneagles Hospitals, Kolkata, Kolkata, India Background: Capsule endoscopy (CE) is an innovative but expensive modality of evaluation of small bowel (SB) diseases and has revolutionized the management of various small bowel disorders. Large and long term data on capsule endoscopy is not available from resource poor countries. Aim: We reviewed our experience with capsule endoscopy to determine the various indications, outcomes and management of positive findings. Methods: We reviewed our database retrospectively for the characteristics and findings of patients who underwent CE examination between August 2003 and October All patients had upper and lower GI endoscopies before the CE study. Given Video Capsule System (Given Imaging Yoqneam, Israel) with M2A/SB capsules was used on all patients. The interpretation of images was done by a single senior gastroenterologist after initial detailed evaluation by a trained technician. Patients were followed up with expectant treatment or surgery and evacuation of capsule. Results: A total of 942 CE examinations were performed from 2003 to 2014 for various indications. The age varied from 12 to 80 years with 69% patients being male. The CE completely evaluated the entire SB in 865 patients (91.8%). Indications for CE were obscure gastrointestinal bleed in 677 (71.9%) cases (514 overt, 163 occult), chronic diarrhea in 141 (15%), abdominal pain in 76 (8.1%) cases and other indications including evaluation of Crohn s disease (CD) or unclassified IBD and surveillance for polyposis syndromes in 48 (5.1%) cases. CE study was normal without any findings in 24.5% of patients. In the setting of obscure bleeding, a definitive source of bleeding was discovered in 398 (58.9%) cases. This included ulcers/ erosions in 279 cases, tumours in 84 cases, and angiodysplasia in 35 cases. It was difficult to characterize ulcers/ erosions, but at least 33 were considered to be due to Tuberculosis (based on abdominal CT scan fine needle aspiration cytology and follow-up) and 121 patients were considered to have Crohn s disease (based on fissuring, serpiginous ulcers with cobble-stone appearance, or histology from tissue obtained at enteroscopy or surgery). Worm infestations were found in 34 of 942 (3.6%) patients.capsule retention was noted in 13 of 942 (1.4%) patients. All these patients had strictures in the small bowel either due to tuberculosis or Crohn s disease. No mortality occurred due to to capsule retention.the current study has limitations because of its retrospective single-center study design. However data was obtained from forms filled at the time of CE, thereby minimizing data collection bias. Conclusion: In this large and long term data on capsule endoscopy study, small bowel ulcer/erosions secondary to Crohn s disease, tuberculosis or NSAID-use are the commonest lesions found for suspected small bowel diseases. Mo1596 Efficient Follow-Up Methods Based on the Findings From Capsule Endoscopy (CE) in Obscure Gastrointestinal Bleeding (OGIB) Takahiro Wakamatsu*, Norimasa Fukata, Toshiro Fukui, Masaaki Shimatani, Kazuichi Okazaki The Third Department of Internal Medicine, Division of Gastroenterology and Hepatology, Kansai Medical University, Hirakata, Japan Background: Although the use of capsule endoscopy is clearly beneficial, there are some cases with no findings and cases where only a small lesion is detected. The challenge of the current CE is to find out ways to manage those cases following such results. Regarding the judgement on the necessity of an invasive test BAE (whether to be performed or only follow-up is required without performing), in different cases where different findings are detected by the non-invasive test CE, there is no clear standard and need more consideration on decision making. Method: The target is 332 cases and 387 events (overt ongoing OGIB: %, overt previous OGIB: %, occult OGIB: %) which is the number of CE performed for OGIB since CE was first introduced in our hospital until September Excluding62cases(CEbleedinggroup)withfinding of overt bleeding in small intestine is obtained by CE, 42 cases with its bleeding source being outside small intestine, and 24 cases with tumorous lesion found, we have divided the 259 cases (CE non-bleeding group) where bleeding source is unclear or there is a finding but no bleeding is found, into different groups (No CE findings - C0, CE vascular lesions - C1, CE erosion/ulcer - C2) and examined its prolonged course accordingly. Result: The breakdown of OGIB in CE bleeding group are ongoing: 62.9% (39/62), previous: 19.4% (12/62), occult: 17.7% (11/62).And for CE non-bleeding group are ongoing: 24.3% (63/259), previous: 47.1% (122/259), occult: 28.6% (74/259).It showed there are many ongoing OGIB in the CE bleeding group, while there are many previous OGIB in the CE non-bleeding group. The findings in CE nonbleeding group are as follows: C0: 93 cases, C1: 73 cases, C2: 93 cases. Of which cases where BAE is performed afterwards are as follows: C0: 2.2% (2/93), C1: 15.1% (11/73), C2: 30.1% (28/93), and cases where a treatment such as hemostasis is performed: C0: 0%, C1: 9.1% (1/11), C2: 78.6% (22/28). In the subsequent course, there was significantly more OGIB relapse occurred in CE bleeding group with 13 cases, than in CE non-bleeding group with 26 cases (log-rank test P!0.01). There was no significant difference in OGIB relapse according to different findings in CE non-bleeding group. Conclusion: In OGIB, it is simple and efficient to decide on medical treatment policy depends only on the presence of bleeding detected by CE or not, without considering other detailed CE findings. This excludes cases where tumorous finding is obtained. For cases where bleeding is not found by CE on the small vascular lesion, it is considered to only require follow-up observation without performing BAE, depends on the condition. There are many cases of relapse in CE bleeding cases, even with the case where the hemostasis is succeeded by performing BAE, careful follow-up and adequate informed consent is necessary. Mo1597 Evaluation of Clinical Factors Associated With Positive Capsule Endoscopy Findings in Patients With Obscure Gastrointestinal Bleeding: a Single-Center Analysis Sunao Shimada*, Toshio Watanabe, Yuji Nadatani, Shogo Takeda, Koji Otani, Fumio Tanaka, Noriko Kamata, Hirokazu Yamagami, Tetsuya Tanigawa, Masatsugu Shiba, Kazunari Tominaga, Yasuhiro Fujiwara, Tetsuo Arakawa Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan Background: Capsule endoscopy (CE) is a useful non-invasive diagnostic tool for patients with obscure gastrointestinal bleeding (OGIB), but the rate of positive findings differs among trials, ranging from 40% to 80%. This difference may be attributable to AB478 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
84 difference in patients backgrounds. Aim: T Aim: To evaluate factors associated with positive findings on CE in patients with OGIB. Methods: Between May 2007 and November 2014, CE was performed in 510 consecutive patients with OGIB (277 men and 233 women; mean age, 66.4 years; age range, years). Findings were considered positive if the observed lesions could explain the bleeding. Findings including isolated red spots and a single small polyp were considered negative. Clinical factors including age, sex, type of bleeding (overt ongoing, overt previous, and occult), smoking habit, alcohol intake, hemoglobin level, nonsteroidal anti-inflammatory drugs (NSAID) use, antithrombotic agent use (antiplatelets and/or anticoagulants), proton pump inhibitor use, and the Charlson comorbidity index (CCI, an indicator of comorbidity) were assessed for association with a positive CE finding using multiple logistic regression. Results: Of 510 patients, 58 patients (11.4%) were excluded because of incomplete visualization of the entire small bowel, and the remaining 452 patients were analyzed. Positive CE results were obtained in 204 patients (45.1%). The majority of lesions (95.1%) were localized to the small bowel, and a few patients (4.9%) had positive lesions in other gastrointestinal tract regions including the esophagus, stomach, duodenum, and colon. Mucosal break (erosions or ulcers) was the most common lesion (47.6%), followed by angioectasia (20.6%). Other lesions included blood in the small bowel without definitive lesions (17.6%) and tumors (14.2%). Univariate analysis showed that advanced age, overt ongoing bleeding, low hemoglobin level, NSAID use, and high CCI (O5) were associated with an increased prevalence of positive findings. Multiple logistic regression analysis showed that high CCI was an independent factor associated with the increased prevalence of positive findings (odds ratio [OR] 2.7, 95% confidence interval [CI] ). The lowest ( g/dl) and middle ( g/dl) tertiles of hemoglobin levels were also independent factors, with the ORs being 2.3 (95% CI ) and 1.7 (95% CI ), respectively. Conclusion: CE may be a useful tool for the assessment of OGIB in patients with severe comorbidities and low hemoglobin levels. present that necessitate treatment with antithrombotic drugs, and the incidence of small intestine lesions increases with the use of these drugs. We compared the incidence of obscure gastrointestinal bleeding (OGIB) in groups of people!65 years old and R65 years old, in our institute, to determine the usefulness of diagnoses using small intestine capsule endoscopy (CE). Method: We examined 419 patients using CE between June 2014 and April Prior to checking for small intestinal lesions, esophagogastroduodenoscopy (EGD) and total colonoscopy (TCS) were both performed to ensure the absence of gastrointestinal bleeding from areas other than the small intestine. After checking both EFD and TCS, CE (Pillcam SB2; Coviden, Mansfield, USA) was applied first; BAE (single balloon enteroscopy; Olympus Medical Systems, Tokyo, Japan) was also used for both diagnosis and treatment. The patients oral medications and small intestine transit times were also compared. Results: Among the 224 patients in the!65-year-old group, we found cases of occult OGIB (n Z 23), overt OGIB (n Z 76), disease of the small bowel (n Z 76), and others (n Z 49). Among the 195 patients in the R65-year-old group, we found occult OGIB (n Z 29), overt OGIB (n Z 98), disease of small bowel (n Z 48), and others (n Z 20). In the!65-year-old group, 20 (9%) patients required antithrombotic drug therapy; 6 (30%) had angioectasia and erosions identified using CE. In the R65-year-old group, 43 (22%) patients required antithrombotic drug therapy; 21 (49%) were identified as having angioectasia and erosions, using CE. The intestinal transit time was significantly longer in the R65-year-old group (313 min) than in the!65-year-old group (265 min). Conclusions: In OGIB patients R65 years old, many more required antithrombotic drug therapy, and many more cases of erosion were observed using CE, than among those!65 years old. The small intestine transit time was also longer in the R65-year-old group. These results suggest that there is an increased risk of mucosal damage associated with the increased use of antithrombotic drugs. For elderly people with OGIB, CE is suggested as a useful method to confirm the diagnosis with relatively little risk. Mo1598 Clinical Outcomes of Capsule Endoscopy in Obscure Gastrointestinal Bleeding: a 10-Year Single-Center Experience Seong Ran Jeon*, Dong Joon Oh, Jin-Oh Kim, Hyun Gun Kim, Tae Hee Lee, Jun-Hyung Cho, Yunho Jung, Bong Min Ko, Joon Seong Lee, Moon Sung Lee Digestive Disease Center, Soon Chun Hyang University Hospital, Seoul, Korea (the Republic of) Aim: Capsule endoscopy (CE) has been used in Korea since its introduction in CE has become the preferred method for examination of the small bowel in most situations. In particular, CE is currently recommended as the first-line modality when evaluating obscure gastrointestinal bleeding (OGIB). This study aimed to evaluate the clinical outcomes of CE in OGIB in the last 10 years. Materials and Methods: From March 2003 to February 2014, 634 patients underwent CE at the Soonchunhyang University Hospital. Of these patients, 327 (51.6%) had OGIB and were enrolled. We retrospectively reviewed the medical records of these patients. Results: Overt OGIB and occult OGIB occurred in 86.2% and 13.8% patients, respectively. The mean patient age was years and 66.1% of the patients were male. A history of non-steroidal anti-inflammatory drugs, anticoagulant, or antiplatelet agent use showed in 41.8%. The mean hemoglobin was g/dl. Patients who received transfusion accounted for 36.4%, and the mean number of transfusion units was The most common CE finding was mucosal ulcer/erosion (64.7%) and the most common final diagnosis was drug-induced enteropathy (60.0%). The diagnostic yield was 69.7%. Most patients who had showed positive findings in CE received conservative treatment (89.2%), followed by specific medical treatment (4.3%), surgical treatment (3.8%), and endoscopic treatment (1.7%). Conclusions: The most common diagnosis according to CE findings was mucosal lesion. Significant lesions were detected in approximately 70% of the patients. In patients with OGIB, CE is a non-invasive and useful diagnostic tool with a high overall diagnostic yield.key words: capsule endoscopy, obscure gastrointestinal bleeding, clinical outcomes Mo1599 Validity of the Small Intestine Capsule Endoscope for Diagnosing Obscure Gastrointestinal Bleeding in Elderly People Ryoichi Sawada* 1, Tomohiro Kato 2, Daisuke Ide 1, Tetsuyoshi Iwasaki 1, Nobuhiko Komoike 1, Masayuki Saruta 1, Seiji Arihiro 1, Mika Matsuoka 1, Naoto Tamai 2, Shoichi Saito 2, Shunsuke Kamba 2, Hisao Tajiri 1,2 1 Division of Gastroenterology and Hepatology Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan; 2 Department of Endoscopy, The Jikei University Shcool of Medicine, Tokyo, Japan Purpose: Angioectasia and erosions are both important causes of unidentified hemorrhages in the small intestines of elderly individuals. The frequency of the primary disease varies according to patient age. Among people R65 years old (elderly, according to the World Health Organization definition), multiple comorbidities may be Mo1600 Is Double-Balloon Endoscopy Applicable to Elderly Patients? Miki Miura*, Daisuke Saito, Mari Hayashida, Shin Ichi Takahashi The Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo, Japan Aim: Double-Balloon Endoscopy (DBE) is useful for detect and treat small intestinal diseases in Japan. However, some serious accidents during DBE were also reported. So there are many sights that we wonder the indication of DBE, especially elderly patients. Thus, we investigated DBE for elderly patients. Methods: Three hundreds sixty-six patients were examined their small intestinal by DBE from January 2013 to March 2014 in our hospital. The subjects were divided into two groups: 1) elderly group of aged 75 or over (nz100, 53 men, 47 women; average age 79.4), 2) nonelderly group of aged 74 or less (nz303,192 men; 111 women; average age 57.1). Medicine (anticoagulants/antiplatelet agents NSAIDs), the reason for taking DBE, comorbidity, the rate to find events, endoscopic diagnosis, and the rate to cause complications. Results: 1) The rate having anticoagulants/antiplatelet agents were 37.0% (37/100) in elderly group and 18.5% (56/303) in non-elderly group, and NSAIDs were 18.0% (118/100) in elderly group and 6.6% (20/303) in non-elderly group. It was significantly higher in elderly group (p!0.001). 2) The rate having comorbidities were 75.0% (75/100) in elderly group and 54.8% (166/303) in nonelderly group. It was significantly higher in elderly group (p!0.001). 3) The most common reason for taking the examination was gastrointestinal bleeding in both groups, 85.0% (85/100) in elderly group and 79.6% (233/303) in non-elderly group. 4) The rate to find events was 66.0% in elderly group and 62.4% in non-elderly group. 5) The common diagnosis were small intestine ulcers and vascular lesions in both groups. In addition, elderly group had less inflammatory bowel diseases than non-elderly group. Endoscopic therapy were: hemostasis in 22.0% (22/100) in elderly group; hemostasis in 10.9% (33/303), polypectomy in 0.7% (2/266), and removal of foreign bodies in 0.4% (1/303) in non-elderly group. No complications were caused by the therapy. 6) Considering complications, one perforation and one aspiration pneumonia were found in elderly group (2.0%); one perforation and one acute pancreatitis were found in non-elderly group (0.8%). No significant difference was found in the rate to cause complications in both groups (pz0.241). Discussion: In this study, the rate of comorbidities and the rate having NSAIDs/antithrombotic agents were significantly higher in elderly group, but no significant difference were found in the rate to find events and the rate to cause complications in both groups. Therefore, it is considered that DBE is safety and effective for elderly patients. Mo1601 Double Balloon Enteroscopy in Younger Versus Older Patients: a Comparative Analysis of Small Bowel Lesions and Risk of Endoscopic Management Syed Amer*, Parth Shah, Malika Gill, Qing Wu, M. E.wyn Harrison, Kevin C. Ruff, Jonathan A. Leighton, Shabana F. Pasha Mayo Clinic, Phoenix, AZ Background: Double balloon enteroscopy (DBE) is useful for evaluation and management of small bowel (SB) disorders. There is limited data on SB findings and Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB479
85 complication rates with DBE in younger (% 60 years) vs older (O60 years) patients. Aim: To compare the diagnostic and therapeutic yield, and complication rates in younger (% 60 years) versus older patients (O60 years). Methods: Retrospective review of all consecutive patients who underwent DBE at a tertiary institution from November 2007 through August Data on patient demographics, indication, route of DBE, findings, histopathology and complications were compared between the two groups. Fisher exact test and Chi-square tests (for categorical variables) were used to test statistically significant difference between groups. Results: 586 patients were included in the analysis; 200 (34%) patients were % 60 years (Group I) and 386 (66%) patients were O 60 years (Group II). Mean age of patients in Group I was 45 years (21-60); and Group II was 74 years (61-99). There was no difference in gender or indications between the two groups. Gender distribution for Group I was 78 (39%) male, 122 (61%) female. For Group II, 214 (55%) were male and 172 (45%) were female. Indications for Group I were obscure overt GI bleed (OGIB) 45 (23%), occult GI bleed 47(24%), abdominal pain 58 (29%), diarrhea 17 (9%), nausea & vomiting 10 (5%), suspected inflammatory bowel disease (IBD) 17 (9%) and surveillance of familial polyposis syndrome (FPS) 3 (2 %). Indications for group II were OGIB 186 (48%), occult GIB 148 (38%), abdominal pain 28 (7%) diarrhea 15 (4%), IBD 14 (4%) and FPS 5 (1%). There was a significantly higher diagnostic and therapeutic yield with DBE for vascular lesions in Group II (tables 1 and 2). There was no difference in the detection of inflammation or tumors in the two groups.there was a higher complication rate of bleeding in Group II (nz10, 3%) compared with Group I(nZ1, 0.5%). There was one perforation in Group I (n Z 1, 0.5%). Conclusion: DBE has a significantly higher diagnostic and therapeutic yield for vascular lesions in older patients (O60 years) compared with younger patients (! 60 years). There is no difference in the detection of inflammation or tumors in the two age groups. There is a higher complication rate of bleeding in older patients, likely due to treatment of vascular lesions. Diagnostic Yield in Younger (% 60 years) vs Older (O 60 years) Patients SB Lesions Group I Younger, (% 60) n (%) Group II Older, (O 60) n (%) P value Angioectasias 7 (4) 86 (22)! Inflammation 25 (12.5) 37 (10) 0.28 Polyp 11 (5.5) 29 (9) 0.39 Mass 9 (5) 12 (3) 0.48 Total 52 (27) 164 (45)! Therapeutic Yield in Younger (% 60 years) vs Older (O 60 years) Patients Therapeutics Group I Younger, (% 60) n (%) Group II Older, (O 60) n (%) P value Argon Plasma Coagulation (APC) 6 (3) 95 (25)! Hemoclip 11 (6) 19 (5) 0.84 Polypectomy 3 (2) 14 (4) 0.2 Total 20 (11) 128 (34)! Mo1602 Overt Obscure GI Bleed. What Is the Outcome in Octogenarians? Analysis of a Large Database Bhaumik Brahmbhatt*, Michael J. Bartel, Carlos R. Simons Linares, Paul T. Kroner, Waseem J. David, Mark E. Stark, Frank Lukens Gastroenterology, Mayo Clinic, Jacksonville, FL Background & Aim: Geriatric population encounters frequently in Gastroenterologic practice, as does overt obscure GI bleed (OGIB). Our aim was to investigate the outcome of octogenarian patients (80 years and older) who underwent therapeutic DBE for overt OGIB in comparison with younger patients. Methods: 1296 patients underwent 1747 double balloon enteroscopies (DBE) between 2/2009 and 9/2013 at a single tertiary center. Of those, 243 patients underwent 362 DBE (204 upper DBE and 158 lower DBE) for overt OGIB. Of the 243 patients, 40 patients were octogenarian (80 years or older) [mean age 83 (range 80-91), 58% male], with the remaining 203 patients being younger than 80 years [mean age 66 (range 18-79), 52% male]. Data was abstracted by retrospective chart review. Main outcome was to identify the yield of DBE, DBE findings and the long term rate of recurrent hemorrhage. Results: Baseline characteristics are shown in table 1. In summary, no statistical significant differences were noticed for gender, Charlson comorbidity index, antiplatelet use, anticoagulation, average number of transfusion, number of prior video capsule endoscopies (VCE), yield of VCE and higher yield of DBE. However, octogenarians had shorter duration of overt OGIB (642 days vs 1326 days).follow up duration following therapeutic DBE was 518 days in the octogenarian cohort and 495 days in the cohort with younger patients. Interestingly, octogenarian had a significantly lower rebleeding rate than younger patients (16% vs.33%). Of note, no procedure related complications were noticed in both cohorts. Limitations: Single center, retrospective studystrength: Large database, long-term follow-up available. Conclusion: Octogenarian patients tolerated therapeutic DBE for overt OGIB well, without reported complications. Despite non-significant higher rate of anticoagulation, octogenarian patients had a significantly lower rebleeding rate following therapeutic DBE.Our results indicate that DBE is safe and has a high diagnostic and therapeutic yield and benefit for treatment of overt OGIB in the octogenarian population. Mo1603 Capsule Endoscopy in Patients With Left Ventricular Assist Devices Is Safe and Effective Brian J. Hanson* 1, Ryan J. Koene 2, Samit S. Roy 2, Nadeem A. Chaudhary 3, Peter Eckman 2, Jose Vega-Peralta 1 1 Gastroenterology, University of Minnesota, Minneapolis, MN; 2 Cardiology, University of Minnesota, Minneapolis, MN; 3 Gastroenterology, Health Parnters, Saint Paul, MN Background/Aims: Capsule endoscopy (CE) is a well-established modality for diagnosis of obscure gastrointestinal bleeding (GIB). Obscure GIB in patients with left ventricular assist devices (LVAD) is not unusual. The safety and efficacy of CE in patients with LVAD are unknown. The aims of this study are to define the safety and efficacy of CE in patients with LVAD. Methods: A retrospective chart review of all patients with LVAD undergoing CE at University of Minnesota Medical Center, Minneapolis, Minnesota between January 2007 and August 2014 was performed. 33 CE studies performed in 24 patients were identified and reviewed for demographic, laboratory, and CE study data in addition to subsequent medical and endoscopic management. Results: A total of 33 CE studies were performed in 24 patients. Mean age at time of first CE was 67 years and 20 patients (83%) were male. Mean duration of LVAD implantation was 1.5 years (SD Z 1.8 years). The indications for CE were obscure occult GIB in 3 cases, obscure overt GIB in 24 and anemia in 6. CE findings included active bleeding in 12 cases (36%). A potential source was visualized in 6 of these. When active bleeding was not seen on CE, a high potential source (AVM, ulceration, tumor) was found in 3 and an intermediate potential source (red spots, erosions) in 3. Active bleeding and potential sources were found in the stomach (n Z 3) and small bowel (n Z 15). The capsule failed to leave the stomach in 2 cases. Mean small bowel transit time was 3 hours 44 minutes. No cardiac device malfunction occurred and no capsules were retained. Small bowel image capture was incomplete in 3 CE studies. Medical intervention was the most common management strategy after CE. Medical management was changed after 25 of 33 CE studies (76%). CE findings were not associated with a change in medical management (p Z 0.69). Endoscopy was performed after CE in 9 patients (27%). Eight of these patients displayed active bleeding on CE and 1 patient had a high potential source. In those patients with active bleeding 6 (75%) were found to have a bleeding source during endoscopy. Sources were an AVM in 4, Dieulafoy lesion in 1 and an indeterminate lesion in 1. Six-month follow up was available in 30 patients. At six-month follow up 10 patients rebled. Positive capsule endoscopy findings were not associated with rebleeding (p Z 0.79). 1 patient died during follow up but it was not related to GIB. Conclusions: CE is safe in patients with LVAD. CE is an effective test for detection of bleeding source in patients with LVAD. Medical management was changed after CE in the majority of cases but CE findings were not associated with this change. Active bleeding during CE can later be successfully treated endoscopically. CE findings are not associated with rebleeding risk. This is the largest retrospective review study of CE in patients with LVAD. AB480 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
86 Mo1604 Recurrent Overt Obscure GI Bleed - Does Therapeutic Enteroscopy Change the Disease Course of Patients With Acquired Von Willebrand Factor (Vwf) Deficiency (Heyde s Syndrome)? Bhaumik Brahmbhatt* 1, Frank Lukens 1, Joseph L. Blackshear 2, Carlos R. Simons Linares 1, Paul T. Kroner 1, Abhishek Bhurwal 1, Mark E. Stark 1, Michael J. Bartel 1 1 Gastroenterology, Mayo Clinic, Jacksonville, FL; 2 Cardiology, Mayo Clinic, Jacksonville, FL Background: Patients with recurrent overt obscure GI bleed (OGIB) frequently undergo repetitive therapeutic enteroscopies. In this context, acquired vwf deficiency (Heyde s syndrome) predisposes both AVM formation and hypocoagulability. Patients at risk for acquired vwf deficiency are those with underlying vascular pathology causing turbulent blood flow, especially aortic valve disease and hypertrophic obstructive cardiomyopathy (HOCM), which all result in destruction of vwf polymers. Aim: Investigate our outcome of patients who underwent therapeutic double balloon enteroscopy (DBE) for overt OGIB stratified by the presence or absence of acquired vwf deficiency or risk factors for acquired vwf deficiency. Methods: 1296 patients underwent 1747 double DBE between 2/2009 and 9/2013 at a single tertiary center. Of those, 243 patients underwent DBE for overt OGIB. Of which, 118 patients were tested for vwf polymers and/or underwent transthoracic echocardiogram (TTE). All patients with abnormal vwf level consistent with Heyde s syndrome and/or very high likelihood for acquired vwf deficiency on TTE (Rmoderate aortic stenosis or regurgitation, Rmoderate mitral regurgitation, HOCM) are in cohort A. All other patients (normal vwf level and no high risk features on TTE) formed cohort B. The main outcome was the rate of recurrent OGIB. Results: 118 patients who met inclusion criteria (mean age 71.7years, SD 10, 44% female), underwent therapeutic DBE for overt OGIB. 8 patients had abnormal vwf level consistent with Heyde s syndrome and 31 patients had normal vwf level. An additional 40 patients had TTE findings with very high likelihood for acquired vwf deficiency. No significant differences in age, gender, duration of bleed, transfusion requirement, number of transfusion, NSAID use, and anticoagulation were found between both cohorts. Also the DBE intubation depth (upper DBE 201cm vs 192cm; lower DBE 144cm vs 130cm), rate of total enteroscopy (70% vs 67%), DBE procedure time (118min vs 127min) and diagnostic yield (73% vs 73%) did not differ significantly between the cohorts. The findings on DBE did not differ significantly in both cohorts with the majority being AVMs. Median follow up was 180 days (range days, SEM 69). 39.5% of patients re-bled, 46% in cohort A and 38% in cohort B (NS). When considering only patients with a minimal follow up of 30 days, or stratifying by patients with only abnormal TTE or only abnormal vwf level, similar results were achieved. Conclusion: Patients with documented acquired vwf deficiency (Heyde s syndrome) and patients with very high likelihood for acquired vwf deficiency based on TTE findings have a non-significant higher rebleeding risk following therapeutic DBE for overt OGIB. Based on our results, those patients should be considered for enteroscopy similarly to patients with normal vwf levels. Mo1605 Transfusion RATES Are Increased in Patients Diagnosed With Non-Isolated Gastrointestinal Angiodysplasias Stephanie H. Mai* 1,2, Thai Bui 1,2, Christian S. Jackson 2 1 Internal Medicine, Loma Linda University Medical Center, Loma Linda, CA; 2 Gastroenterology, VA Loma Linda Healthcare System, Loma Linda, CA Background: While gastrointestinal angiodysplasias (GIAD) are commonly diagnosed in the small bowel, they can be located in other areas of the gastrointestinal tract. Complications of GIAD, which include re-bleeding and readmission, have not been extensively analyzed in non-isolated GIAD. We performed a retrospective study to determine re-bleeding and readmission rates between patients with GIAD isolated to the small bowel (ISGIAD) and those with non-isolated angiodysplasias (NIGIAD) seen on video capsule endoscopy. Aim: To investigate the clinical impact of GIAD on re-bleeding and readmission rates between patients with ISGIAD and those with NIGIAD at a single institution over a seven-year period. Materials and Methods: 425 patients underwent video capsule endoscopy (VCE) between at the VA Loma Linda Healthcare System. All 425 patients also underwent esophagogastroduodenoscopy (EGD) and colonoscopy prior to VCE. 96 patients were diagnosed with small bowel GIAD on VCE. The primary indications for VCE were obscure occult and obscure overt GI bleeds. Patients with other indications including irritable bowel syndrome (nz6) and malignancy evaluations (nz3) were excluded. Of the 87 patients included in the study, 57 were diagnosed with ISGIAD and 30 with NIGIAD. We compared rebleeding rates and readmission rates between the two groups. Re-bleeding was defined as a transfusion of two units of packed red blood cells or more in a oneyear period after video endoscopic evaluation. Readmission was defined as any hospitalization during a six-month period after discharge. Results: Risk factors associated with higher transfusion rates included coronary artery disease (CAD), chronic kidney disease (CKD) and congestive heart failure (CHF) on univariate analysis. When adjusted for these risk factors on multivariate analysis, the odds ratio (OR) for transfusions in patients with NIGIAD was found to be (CI , pz 0.036). No association was found between NIGIAD and readmission rates. Conclusion: In this retrospective analysis of GIAD at a single institution over a seven-year period, patients with NIGIAD had a four times odds of receiving transfusions within one year after endoscopic evaluation, when adjusted for potential confounders. Mo1606 Outcomes for Patients With Transfusion-Dependent Obscure GI Bleeding Undergoing Double Balloon Enteroscopy and Therapy for Small Bowel Angioectasias Kunal Dalal* 1, Nicholas a. Rogers 1, Michael V. Chiorean 2, Debra J. Helper 1, Monika Fischer 1 1 Indiana University School of Medicine, Indianapolis, IN; 2 Gastroenterology, Virginia Mason Medical Center, Seattle, WA Introduction: Double balloon enteroscopy (DBE) is often undertaken for evaluation of obscure gastrointestinal bleeding (OGIB). Small bowel angioectasias (SBAs) are frequently diagnosed lesions during DBE for OGIB and targeted for therapy. The natural history of SBAs is not well characterized, and data on longterm efficacy, bleeding recurrence, and effect on transfusion requirement posttherapy are limited. Objective: To determine the risk of recurrent bleeding during long-term follow-up after treatment of SBAs with DBE. Methods: Using a prospective IRB-approved research database, we identified patients who underwent DBE for OGIB between 3/2006 and 9/2013 at a tertiary center. Patients with transfusion-dependent anemia prior to DBE who were found to have at least one SBA and had successful therapy were included. Patients with other vascular lesions without SBAs were excluded. Comorbidities, index DBE characteristics and findings, and repeat endoscopic findings were documented. Follow-up was conducted through 10/2014. Primary outcome was bleeding recurrence, defined as requirement for blood transfusion(s) post-dbe, repeat endoscopy to evaluate new or worsening anemia or suspected GI bleeding, or intravenous iron infusions. Recurrence was assessed by review of electronic medical records (EMR), including our center s blood bank and endoscopy records. For patients who did not have these outcomes definitively documented, phone follow-up was attempted. Results: 137 patients (47.4% female) with mean age were included. Outcomes were assessed in 105 patients (30 by phone); outcomes could not be determined in 32 due to insufficient follow-up, death, or inability to establish phone contact. Of those assessed, 84 (80.0%) had confirmed recurrence, including 66 (62.9%) who required further transfusions. For recurrence confirmed via EMR (nz75), median time to recurrence was 3.2 months (range, ), with median follow-up of 16.4 months (range, ). 67 patients (63.8% of those assessed) required a total of 171 repeat endoscopies, including 35 patients (33.3%) requiring 55 repeat DBEs. 49 patients (46.7% of those assessed) were found to have additional SBAs on repeat endoscopy; these SBAs were felt to represent a likely cause for recurrence in 42 patients (40.0%). Location of these SBAs correlated with index findings in 57.1%. On bivariate analysis, recurrence was not associated with age, sex, comorbidities, bi-directional DBE, bleeding AVM(s) or multiple locations of AVMs on index DBE (all po0.05); transfusion-dependent recurrence was associated with baseline overt bleeding (pz0.029). Conclusions: Bleeding recurrence with further transfusion requirement was common after DBE treatment for SBAs in patients with a history of transfusion-dependent anemia. Additional SBAs were commonly implicated in these recurrent cases. Mo1607 No Significant Differences in the Clinical Outcome of Japanese Patients With Upper Gastrointestinal Bleeding After Endoscopic Hemostasis Between Weekday and Weekend Admission Minoru Fujita* 1, Noriaki Manabe 2, Takahisa Murao 1, Manabu Ishii 1, Hiroshi Matsumoto 1, Ken-Ichi Tarumi 1, Tomoari Kamada 1, Akiko Shiotani 1, Ken Haruma 1 1 Division of Gastroenterology, Department of Medicine, Kawasaki Medical school, Kurashiki, Japan; 2 Division of Endoscopy and Ultrasound, Department of Clinical Pathology and Laboratory Medicine, Kawasaki Medical School, Kurashiki, Japan Background and Aim: With the recent technological advances in the field of endoscopic hemostasis (EH), the prognosis of patients with gastrointestinal (GI) bleeding has been improved. In western countries, it has been suggested that patients with upper GI bleeding (UGIB) during the weekend have a worse outcome compared with weekdays. However, there have been no data regarding these matters in Japan. The aim of this study was to evaluate the clinical course of UGIB patients after emergency endoscopy (EE), and elucidate differences in clinical outcomes between the daytime on weekday admission and others. Methods: From January 2011 to December 2013, the medical records of patients who had undergone EE for UGIB were retrospectively reviewed. The severity of UGIB was evaluated by Glasgow-Blatchford (GS) score and AIMS65 score. Patients who stopped Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB481
87 UGIB with improved iron deficiency anemia after EE were defined as those with good clinical course. Results: [Clinical characteristics] 415 consecutive patients were enrolled. These patients were divided into 2 groups; group A (daytime on weekday admission: 185 patients [44.6%], mean age; years) and group B (night on weekday or weekend admission: 230 patients [55.4%], mean age; years). There was no significantly difference in the frequency of taking antithrombotics and non-steroidal anti-inflammatory drugs, although cerebrovascular diseases were significant more in group B (30.9%, pz0.001) compare with group A (11.4%). Patients in group A (24.3%, pz0.003) taking proton pomp inhibitors were significant more than group B (15.7%). Blood transfusion was more frequently observed in group A (53.0%, pz0.011) compare with group B (40.4%).[Clinical course] The mortality rate was 3.6%. There was no significant difference in GB score (pz0.17) and AIM65 score (pz0.99) between the 2 groups and the rate of patients with clinical good course was not significantly different between group A (65.9%) and group B (63.9%, pz0.67). However, patients in group B (57.8%, pz0.006) who underwent EH were significantly more compare with group A (46.5%) (Fig). Conclusions: The mortality rate of Japanese patients with UGIB was lower than that of western patients. There were no significantly differences in clinical outcomes between daytime on weekday admission and others partly because patients could undergo enough EH even though on a weekday night or weekend. Mo1608 Overt Obscure GI Bleed - Is a Tagged-Red-Blood-Cell Bleeding Scan Helpful? Bhaumik Brahmbhatt*, Michael J. Bartel, Carlos R. Simons Linares, Paul T. Kroner, Donnesha Clayton, Mark E. Stark, Frank Lukens Gastroenterology, Mayo Clinic, Jacksonville, FL Background & Aim: Tagged-red-blood-cell bleeding scan (tagged-rbc scan) are frequently used early in the work up overt obscure GI bleed (OGIB). It remains unclear if tagged-rbc scans are of benefit in the setting of overt OGIB, when patients eventually undergo therapeutic DBE. Methods: 1296 patients underwent 1747 double balloon enteroscopies (DBE) between 2/2009 and 9/2013 at a single tertiary center. Of those, 243 patients underwent 362 DBE (204 upper DBE and 158 lower DBE) for overt OGIB. Of the 243 patients, 55 patients underwent tagged-rbc scan within 24hours of overt OGIB. Data was abstracted by retrospective chart review. Main outcome was to identify if a possible bleeding scan increases the yield of DBE and eventually changes the rebleeding rate during follow up. Results: Baseline characteristics are shown in table 1. In summary, no statistical significant differences were noticed for gender, age, antiplatelet use, anticoagulation, number and yield of prior video capsule endoscopies (VCE) as well as the overall duration of overt OGIB prior DBE. Interestingly, the yield of DBE dropped from 70% to 60% (pz0.03) following a positive tagged-rbc scan.follow up duration following therapeutic DBE was 332 days in the positive tagged-rbc scan cohort and 404 days in the negative tagged-rbc scan cohort. Although not statistically significant, patients in the positive tagged-rbc scan cohort had a higher rate of rebleeding than patients with a negative tagged-rbc scan prior DBE (42% vs 19%). Limitations: Single center, retrospective study, small sample size, missing of other radiology and nuclear medicine techniques, lack of patients without tagged-rbc scanstrength: Long-term follow-up available. Conclusion: Tagged-RBC scans do not appear to be beneficial in patients with overt OGIB. The majority were negative (33 of 55; 60%) despite a timely overt bleed. Additionally, patients with a positive bleeding scan had eventually a lower yield of finding the culprit lesion on DBE. Overall, patients who underwent a tagged- RBC scan prior DBE (nz55) and no tagged-rbc scan prior DBE (nz186) had similar yields to find the bleeding culprit lesion on DBE 65% vs. 67%.Small bowel hemorrhages tend to bleed frequently intermittently. Prolonging the diagnostic time prior the definite therapeutic DBE could explain why patients who undergo bleeding scan often have lower diagnostic yields. Mo1609 Endoscopic Treatment for Tumorous Duodenal Lesions -EMR vs ESD- Yuichi Kojima*, Toshihisa Takeuchi, Naoki Yorifuji, Munetaka Iguchi, Kaori Fujiwara, Satoshi Harada, Kazuhiro Ota, Shoko Edogawa, Toshihiko Okada, Kazuki Kakimoto, Sadaharu Nouda, Ken Kawakami, Yosuke Abe, Takuya Inoue, Kazuhide Higuchi 2nd Dep of Internal Medicine, Takatsuki, Japan Purpose: Duodenal tumors are rare. Their biological malignancy remains to be clarified, and a consensus regarding therapeutic strategies has not been reached. Furthermore, there are few reports on endoscopic treatment. It is technically difficult, and complications may become serious. In this article, we present the results of endoscopic treatment for tumorous duodenal lesions in our hospital, and compare them among different procedures. Methods: The subjects were 24 patients who underwent endoscopic treatment in our hospital between April 2005 and May 2014 (8 with duodenal adenoma and 16 with early cancer). The procedures consisted of EMR in 12 patients (a two-channel scope was used), ESD in 8, and hybrid EMR in 4. The following items were compared between EMR and ESD/hybrid EMR groups (nz12 each): age, sex, treatment phase (early phase: 2005 to 2009, late phase: 2010 to 2014), lesion site, size, macroscopic type, preoperative biopsy/pathology, operation time, presence or absence of hemostatic treatment, presence or absence of clip plication, pathological findings of a resected specimen, total resection rate, intra-/ postoperative perforation rate, and residual tumor/recurrence rate. Results: There were no significant differences in the patient age or sex between the two groups. The lesion size was larger in the ESD/hybrid EMR group. However, there were no significant differences in the site or macroscopic type. When the results of preoperative biopsy were evaluated as Group 5, ESD or hybrid EMR was selected. In the EMR group, clip plication was performed. In the ESD/hybrid EMR group, the total and curative resection rates were significantly higher than in the EMR group, but the intraoperative perforation rate was also significantly higher. In 1 patient, the procedure was switched to emergency surgery intraoperatively (the patient had received steroid therapy). There was no association between the intraoperative perforation rate and underlying disease/oral administration of antithrombotic drugs. During a 7-year follow-up, multiple metachronal lesions were noted in 1 patient. In a significantly higher proportion of patients taking antithrombotic drugs, EMR was selected. Conclusion: ESD for duodenal tumors was compared with EMR. In patients who underwent ESD, the intraoperative perforation rate was higher, suggesting technical difficulty. On the other hand, in the EMR group, the proportion of patients with positive reactions at the margin of the resected specimen was higher; long-term follow-up may be necessary. The two procedures have some merits and limitations, but the selection of an appropriate procedure must be examined to improve the total resection rate and prevent complications in the future. Mo1610 Usability Assessment of Endoscopic Mucosal Resection With a CAP-Fitted Panendoscope for Superficial Epithelial Type of Sporadic Non-Ampullary Duodenal Adenoma/Carcinoma Daisuke Maruoka* 1,2, Makoto Arai 1, Hideaki Ishigami 1, Kenichiro Okimoto 1, Shoko Minemura 1, Tomoaki Matsumura 1, Tomoo Nakagawa 1, Tatsuro Katsuno 1, Osamu Yokosuka 1 1 Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University, Chiba, Japan; 2 Clinical Research Center, Chiba University Hospital, Chiba, Japan Aims: In the duodenum, en bloc resection is often difficult by conventional endoscopic mucosal resection (EMR) especially of superficial epithelial lesions, which do not have any type I (protruded) component because adequate mucosal lift by submucosal injection is often inhibited by the existence of Brunner s glands. Meanwhile, the rate of en bloc resection of endoscopic submucosal dissection (ESD) in the duodenum is high. However, the rate of ESD complications, such as perforation, in the duodenum is much higher than that in the other digestive tracts, and AB482 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
88 the indication for duodenal ESD is highly controversial. EMR with a cap-fitted panendoscope (EMR-C) is known as an effective treatment for esophageal tumors in particular. Recently, we have performed EMR-C as therapy for the superficial epithelial type of sporadic non-ampullary duodenal adenoma/carcinoma (SNADA) in our establishment. However, efficacy for duodenal tumors has not yet been reported. In this study, we assessed the efficacy of EMR-C for the superficial epithelial type of SNADA. Methods: We retrospectively evaluated 74 patients with SNADA who underwent endoscopic resection between May 2004 and October 2014 at our establishment. In addition, we assessed and compared the incidence rate of complications and frequency rate of en bloc resection according to the macroscopic appearance of the lesions and the methods of mucosal resection, especially of the superficial epithelial type of SNADA, between EMR-C and EMR. Results: The mean age of the patients was years and 52 were male. Seventy-nine SNADA lesions were resected. The final pathological diagnoses, low-grade dysplasia, highgrade dysplasia, and intramucosal carcinoma were 21, 27, and 31, respectively. The mean size of the lesions was mm. The numbers of macroscopic appearance of types Ip, Is, Is + IIa, IIa, IIa + IIc, and IIc according to the Paris endoscopic classification were 5, 9, 3, 27, 21, and 14, respectively. The numbers of lesions resected by polypectomy, EMR, EMR-C, strip biopsy, and ESD were 1, 33, 25, 9, and 11, respectively. The perforation rate with EMR and EMR-C were significantly lower than that with ESD (0% and 4.0% vs. 27.3%; p Z and 0.041, chi-square test). For superficial epithelial lesions, the rate of en bloc resection in EMR-C was 96.0% (24 in 25 lesions), which was significantly higher than that in EMR (vs. 68.4%, 13 in 19 lesions; p Z , chi-square test). Furthermore, no significant difference in the mean size of the resected superficial epithelial type of SNADA was observed between EMR-C and EMR ( mm vs mm; p Z 0.361, Mann- Whitney U test). Conclusions: EMR-C had a significant higher rate of en bloc resection of the superficial epithelial type of SNADA than EMR. EMR-C is a safe and effective treatment of SNADA, especially of the superficial epithelial type. Mo1611 Double Balloon-Assisted Deep Enteroscopy for the Study of Patients Suspected of Complicated Celiac Disease Hui Jer Hwang* 1, Sonia I. Niveloni 1, De Maria Julio 2, Gabriela I. Longarini 1, María Laura Moreno 1, Ana F. Costa 1, Edgardo Smecuol 1, Emilia Sugai 1, Horacio Vázquez 1, Roberto M. Mazure 1, Miguel E. Promenzio 2, Fernando Ragone 2, Guidi Martin 2, Ana Cabanne 1, Matano Raul 2, Eduardo Mauriño 1, Julio C. Bai 1 1 C. Bonorino Udaondo Gastroenterology Hospital, Buenos Aires, Argentina; 2 Hospital de Alta Complejidad El Cruce, Florencio Varela, Argentina Background: Refractory celiac disease, ulcerative jejuno-ileitis and intestinal lymphoma are severe complications of celiac disease (CD). Since they significantly affect the survival of patients, early and accurate diagnosis is mandatory for prognosis and therapeutic approach. In recent years, double balloon-assisted deep enteroscopy (DBE) has led to improvement on the diagnosis of complications in CD. Aim: To evaluate the usefulness of DBE in patients with suspected CD complications. Materials and Methods: a retrospective, multicenter and observational study was performed in 15 CD patients (9 female) collected from January 2011 to May 2014 in a specialized small bowel clinic. All patients underwent to DBE examination (Fujinon EN-450P5/20 Enteroscope) for suspicion of CD complications. Median age at diagnosis of CD was 46 yr. (range 31-64) and 50 yr. (range: 31-70) at the suspicion of complications. Symptoms and complementary image findings (ulcers, strictures, dilated loops or wall thickening) in enteroclysis examination (nz11), abdominal CT (nz13), video capsule endoscopy (VCE) (nz5), entero-ct (nz4) and positron emission tomography (PET-CT scan) (nz5) were evaluated and compared to those findings of DBE. The most common symptoms of patients were: abdominal pain (73%), intestinal suboclussion (33%), chronic diarrhea (73%), and weight loss (80%). 20 EDB (10 anterograde, 4 retrograde and 3 antero-retrograde, based on location of previous observed lesions on other imagine studies) were performed. Results: Compared with finding from other complementary imaging studies, DBE agreed with in 50% of enteroclysis examinations, 92% of CT scans and 75% of the entero-ct and VCE. DBE detected lesions undiagnosed in 20% of enteroclysis and 8% of CT studies. In 6 patients there was a high suspicion of intestinal lymphoma by CT and/or PET-CT. In 3 of them there was no evidence of lymphoma at both, the histological examinations of DBE and the follow-up. In another 3 patients, the diagnosis of intestinal lymphoma was demonstrated by the biopsy performed at the DBE (nz2) or surgery. Conclusion: Our retrospective study confirms that DBE is a useful adjuvant tool for diagnosing complications in CD patients. Mo1612 Recurrent Small Bowel Obstructions of Unclear Etiology - What Does Our Double Balloon Enteroscopy Find? Kristina Seeger* 2, Bhaumik Brahmbhatt 1, Michael J. Bartel 1, Paul T. Kroner 1, Carlos R. Simons Linares 1, Mark E. Stark 1, Frank Lukens 1 1 Gastroenterology, Mayo Clinic, Jacksonville, FL; 2 Internal Medicine, Mayo Clinic, Jacksonville, FL Background: Patients with suspected recurrent small bowel obstructions (SBO) are common in gastroenterological practice; however the etiology of SBO remains frequently unclear unless patients undergo resection. Aim: Investigate our outcome in patients with recurrent small bowel obstruction who underwent diagnostic double balloon enteroscopy. Methods: 1296 patients underwent 1747 double balloon enteroscopies (DBE) between 2/2009 and 9/2013 at a single tertiary center. Of those, 19 patients underwent 23 DBE (9 upper DBE and 14 lower DBE) for workup of recurrent small bowel obstruction, presenting with intermittent abdominal pain associated with symptoms: nausea, vomiting and abdominal distension. Timely cross sectional imaging was available for 13 patients. Data was abstracted by retrospective chart review. Primary outcome was to identify the etiology of recurrent SBO. Results: 19 patients (mean age 62.8 years, SD 13, 58% female) underwent DBE for recurrent partial small bowel obstruction (SBO). 8 patients had previous bowel resections, 7 had previous bowel resections and radiation, 1 had only a gynecologic intervention and 1 had underlying inflammatory bowel disease. 2 patients had no previous abdominal surgical or medical history. Duration of recurrent symptoms lasted for a median of 12 months (range 0.5 months to R60 months). Of the available 13 CT scans, 4 (31%) were normal and 9 (69%) revealed small bowel dilation with suspected transition point.in all cases a small bowel stricture was identified on DBE (5 on upper DBE, 14 on lower DBE, median stricture diameter 9mm, range 5-10mm). Pathology report in conjunction with endoscopic stricture impression revealed 5 (27%) NSAIDs related, 7 (37%) non-specific, 4 (21%) radiation, 1 (5%) tumor induced (lymphoma), 1 (5%) Crohn s disease, and 1 (5%) anastomotic stricture. 7 patients underwent concomitant small bowel dilation. Follow up data was available for 13 patients of who 9 eventually underwent surgery, 1 for lymphoma diagnosis, however 4 for non-specific strictures and 2 NSAIDs stricture, with the remaining for 1 anastomotic and 1 radiation stricture. Limitations: Single center, retrospective study, heterogeneous patient population, CT studies not optimized for small bowel. Conclusion: This unique cohort study of patients with recurrent small bowel obstructions, who underwent DBE, demonstrates that the majority of strictures were induced by NSAID use and non-specific strictures, likely also NSAID related, despite an underlying significant history of previous small bowel surgery. In contrast, only a minority of strictures were related to radiation or anastomosis. Of note, 1 stricture (5%) was caused by lymphoma in this cohort. Given the absence of significant pathology in most cases, future studies should address whether small bowel dilation is successful as surgical sparing option. Mo1613 CAP-Assisted Retrograde Single Balloon Enteroscopy Results in High Terminal Ileal Intubation Rate Darin Dufault*, Andrew Brock Medical University of South Carolina, Charleston, SC Background: Retrograde single balloon enteroscopy (RSBE) provides the ability to evaluate the distal small bowel and provide appropriate therapy when necessary. Intubation of the terminal ileum (TI) is a major rate limiting step, due to the flexibility of the enteroscope and lack of an anchoring enteroscope balloon, with failure rates as high as 30%. Cap-assisted endoscopy has proven beneficial for cecal intubation, adenoma detection, and visualization of the ampulla of Vater, by peeling away mucosal folds. We have noticed that it similarly aids in TI intubation during RSBE by facilitating opening of the ileocecal valve (ICV). Aims: The primary aim of this study was to measure the TI intubation rate using cap-assisted RSBE. Other procedural details and outcomes were also measured. Methods: A total of 36 consecutive RSBEs performed between July 2011and May 2014 at the Medical University of South Carolina were retrospectively reviewed. All procedures were performed or supervised by our center s deep enteroscopist (AB). Outcomes measured included TI intubation rate, procedure time, depth of maximal insertion (DMI), diagnostic yield (DY), therapeutic yield (TY), and complications. Results: TI intubation rate was 97% (35/36). The one failure was due to stool completely obscuring the cecum. Median procedure time was 54 minutes, with a mean DMI of 68cm beyond the ICV. DY and TY were 61% and 25%, respectively. There were no complications.limitations: Single enteroscopist at single center. Conclusion: Cap-assisted RSBE results in a high TI intubation rate, without compromise to safety or procedural yield. Mo1614 Antegrade DBE Is More Effective Than Retrograde DBE for Evaluation and Management of Small-Bowel Disorders Syed Amer*, Malika Gill, Parth Shah, Qing Wu, M. E.wyn Harrison, Kevin C. Ruff, Jonathan A. Leighton, Shabana F. Pasha Mayo Clinic, Phoenix, AZ Background: Double balloon enteroscopy (DBE) is useful for evaluation and management of small bowel (SB) disorders. There is limited data on the yield and complications of antegrade (adbe) and retrograde DBE (rdbe). Aim: To compare the diagnostic and therapeutic yield, and complication rates with adbe and rdbe. Methods: Retrospective review of all consecutive patients who underwent DBE at a tertiary institution from November 2007 through August Data on patient demographics, indication, findings, and complications were compared between two groups based on the route of DBE. Fisher exact test and Chi-square tests (for categorical variables) were used to test statistically significant difference between groups. Results: 573 patients were included in the analysis; 361 (63%) had adbe and Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB483
89 212 (37%) had rdbe. There was no difference in age, gender or indications between the two groups. Mean age of patients who underwent adbe was 68.5 years (21-94); and rdbe was 61.2 years (21-92). Gender distribution for adbe: 181 (50%) male, 180 (50%) female. For rdbe, the gender distribution was 104 (49%) male, 108 (51%) female. Indications for adbe were obscure overt GI bleed (OGIB) 158 (44%), occult GI bleed 131 (36%), abdominal pain 35 (10%), diarrhea 19 (5%), nausea & vomiting 10 (3%), suspected inflammatory bowel disease (IBD) 13 (4%) and surveillance of familial polyposis syndrome (FPS) 5 (1 %). Indications for rdbe were OGIB 67 (32%), occult GIB 59 (28%), abdominal pain 48 (22%), diarrhea 20 (9%), suspected IBD 18 (8%) and FPS surveillance 3 (1%). There was a significantly higher diagnostic yield with adbe for vascular lesions(table 1). There was no difference between adbe and rdbe for SB inflammation or tumors. There was also a significantly higher therapeutic yield with adbe (table 2).There was a higher complication rate of bleeding with antegrade DBE (nz10, 3%) compared with retrograde DBE (nz1, 0.4%). There was one perforation (n Z 1, 0.4%) with retrograde DBE. Conclusion: Antegrade DBE has a significantly higher diagnostic and therapeutic yield than retrograde DBE for all SB lesions, mainly angioectasias. Our results support antegrade DBE as the initial approach for majority of patients with suspected SB disorders. Retrograde DBE may be useful when antegrade DBE is negative, and in management of patients with known distal SB lesions. detected outside of the small bowel, even after repeated negative EGD s and colonoscopies. Table 1. Diagnostic Yield with Antegrade and Retrograde DBE SB Lesions Antegrade DBE n (%) (n[361) Retrograde DBE n (%) (n[212) P value Angioectasias 88 (24) 4 (2)! Inflammation 34 (9) 28 (13) 0.17 Polyp 29 (8) 10 (5) 0.17 Mass 14 (4) 7 (3) 0.82 Total 165 (45) 49 (23)! Table 2. Therapeutic Yield with Antegrade and Retrograde DBE Therapeutics Antegrade DBE n (%) (n [ 361) Retrograde DBE n (%) (n[212) P value Argon Plasma Coagulation (APC) 93 (26) 8 (4)! Hemoclip 25 (7) 5 (2) Polypectomy 10 (3) 7 (3) 0.8 Total 128 (36) 20 (9)! VCE. Gastric ulcer. Mo1615 Suspected Mid-Gastrointestinal Bleeding: How Often the Source of Bleeding Is Detected. Outside of the Small Bowel? Evgeniya Myznikova, Ekaterina Ivanova, Oleg I. Yudin, Denis Seleznev, Evgeny Fedorov* Moscow University Hospital N31, Moscow, Russian Federation The objective of the study is to estimate the incidence of detection of the true source of obscure GI bleeding in the reference-center, after negative EGD and colonoscopy, utilizing capsule enteroscopy (CE) and balloon-assisted enteroscopy (BAE). Methods and Procedures: From to we examined 132 pts. (m-76, f-56, mean age 52,214,7 yrs., range 17-89) with suspected small bowel bleeding. We ve observed 97 planned and 35 time-urgent pts.; there were 105 pts. with obvious and 27 with occult bleeding. We performed 99 CE and 167 BAE; in 58 (44,0%) pts. BAE was performed after the CE. Results: The source of obscure bleeding was found in 109 (82,6%) patients. In 12 (11,0%) cases the source of bleeding has been found in the upper and lower gastrointestinal tract: gastric erosions and ulcers in 5 (4,6%), GAVE-syndrome in 1 (0,9%), duodenal polyp in 1 (0,9%), hemosuccus pancreaticus in 1 (0,9%), cecal ulcers in 2 (1,8%), advanced tumor in cecum in 1 (0,9%), cavernous hemangioma in cecum in 1 (0,9%). In 97 (89,0%) cases the source of obscure bleeding was found in the small bowel: vascular pathology in 40 (41,2%); erosions and ulcers in 26 (26,8%); tumors in 26 (26,8%) pts.; diverticulum in 4 (4.1%); post-polypectomy area in 1 (1.1%). Endoscopic hemostasis was performed in 19 (17,4%) cases of multiple vessel malformations using APC and clipping (including APC of GAVE-syndrome (1) and clipping of cavernous hemangioma in cecum (1); polyp removal - in 5 (4,6%)cases(includingduodenalhyperplasticpolyp(1).Therewere25(22,9%) pts. who underwent surgery (in case of the small bowel tumors (17), diverticulum (4) and vascular pathology with ongoing intestinal bleeding (2), ulcer of ileotransverzoanastamozis (1), erosive ileitis (1). It was 1 (0,9%) pt. with hemosuccus pancreaticus who underwent embolization in the cause of angiography. In 60 (55,1%) cases conservative treatment was applied. Conclusions: CE in combination with BAE gives opportunity to detect the true source of bleeding in 82,6% of patients with suspected mid-gastrointestinal bleeding, while in 11,0% of them it is EGD. Gastric ulcer is confirmed Mo1616 Enteroscopically Visible Differences Between Bleeding and Uncomplicated Small Bowel Tumors Denis Seleznev*, Ekaterina Ivanova, Oleg I. Yudin, Evgeniya Myznikova, Ekaterina Tikhomirova, Evgeny Fedorov Endoscopy, Moscow University Hospital N 31, Moscow, Russian Federation Small bowel tumours (SBT) usually considered to be a rare disease which diagnosed and treated untimely, often due to complications. Aim: To compare localization, histological type and therapeutic approach for bleeding and uncomplicated SBT, diagnosed endoscopically. Materials: From I.2007 to VIII.2014 we have examined 61 pts. (m-28, f-33, ranged years, mean age years) with SBT using videocapsule endoscopy and balloon-assisted enteroscopy. Obscure bleeding was the reason for enteroscopy in 28 (45.9%) of them: 17 (60.7%) pts. had overt bleeding and 11 (39.3%) pts. - occult bleeding. In 15 (53.6%) pts. bleeding happened for the first time, in 13 (46.4%) pts. that was recurrent bleeding (8 of them had more than 3 rebleedings). The average duration of a disease before establishing the diagnosis AB484 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S :
90 was 36 months. For the same period of time ( ) there were no emergency operations in our hospital for small bowel bleeding caused by SBTs. The indications for enteroscopy in the other 33 (54.1%) pts. were as follows: in 24 (39.3 %) pts. SBT revealed by other methods of examination and in 9 (14.8%) pts. non-specific complaints (abdominal pain, fever, leukocytosis, etc.). Results: Complicated SBTs were located mostly in jejunum - 21 (75.0%) pts., while uncomplicated were equally distributed along the small intestine. Histological types of 56 revealed SBT are shown in the table. Five patients after VCE with non-epithelial tumors abandoned the following examination and treatment.surgery was performed in 16 (64.0%) pts., endoscopic treatment in 5 (20.0%) and conservative treatment in 3 (12.0%) pts. with bleeding SBTs; in accordance - in 5 pts. (16.1%), 19 (61.3%) pts. and 7 (22.6%) pts. with uncomplicated SBTs. Conclusions: In our series small intestinal tumors in 45.9% of cases complicated with bleeding; up to 75.0% of bleeding SBTs are located in jejunum. GIST, NET and carcinomas are most frequently manifested with bleeding. Preoperative diagnosis is difficult, that s why the average disease duration time was 36 months and almost half of bleeding cases had recurrent bleeding. Surgery is required for 64.0% of pts. with bleeding SBTs and only for 16.1% pts. with uncomplicated SBTs. Histological type of a tumor Bleeding SBT Uncomplicated SBT GIST 6 (24.0%) 0 Neuroendocrine tumors (NET) 5 (20.0%) 3 (9.7%) Adenocarcinoma 4 (16.0%) 0 Peutz-Jeghers hamartomas 2 (8.0%) 11 (35.5%) Lymphoma 2 (8.0%) 3 (9.7%) Undifferentiated carcinoma 1 (4.0%) 0 Hyperplastic polyp 1 (4.0%) 7 (22.6%) Tubular adenoma 1 (4.0%) 3 (9.7%) Lymphangioma 1 (4.0%) 0 Cavernous hemangioma 1 (4.0%) 1 (3.2%) Angiofibrolipoma 1 (4.0%) 0 Lipoma 0 1 (3.2%) Leiomyoma 0 1 (3.2%) Metastatic lesion 0 1 (3.2%) Total 25 (100%) 31 (100%) BAE. Actively bleeding jejunal lymphangioma Mo1617 Histological and Lavage Markers for Food Allergy Are Not Reliable Predictive of Food Intolerance in Patients With IBS Proven to Be Food Intolerant on Confocal LASER Endomicroscopy Annette Fritscher-Ravens* 1, Marie J. Mösinger 1, Mark Ellrichmann 1, Zino Ruchay 1, Christoph Röcken 2, Jochen Brasch 3, Peter J. Milla 4 1 Internal Medicine I, Experimental Endoscopy, Kiel, Germany; 2 Institute Pathology, University Hospital Kiel, Kiel, Germany; 3 Dermatology, University Hospital Kiel, Kiel, Germany; 4 Institute of Child Health, University College London, London, United Kingdom Introduction: Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder with a poorly understood etiology. Beside genetic factors the pathogenesis is considered to involve activation of the innate and acquired immune system leading to chronic intestinal low-grade inflammation. Real time dynamic functional imaging using confocal laser endomicroscopy (CLE) in patients with IBS and suspected food intolerance has been used to monitor the onset and evolution of pathophysiological processes in their natural environment at a microscopic level. We evaluated whether additional parameters, eosinophil count from histology, eosinophil cationic protein (ECP) and Tryptase from duodenal fluid of patients who reacted food challenge on CLE were predictive of food intolerance. Aim: To determine whether in addition to CLE, the presence of eosinophils histologically, eosinophil cationic protein(ecp) and tryptase in duodenal fluid of patients who reacted to food on CLE (CLE+), were predictive of food intolerance compared to healthy controls (HC). Methods: Duodenal biopsies and lavage fluid was collected from CLE+ patients and compared with 10 HC (6male, 56,75 +/- 17,7; range:31-78 years). All were examined for mucosal eosinophils by HE-staining (mean of 10 high power-fields(hpf)), eosinophilic cationic protein (ECP) and a-tryptase. Results: 46 IBS patients (27 female, mean age: 46,714,4; range: 21-78years) were CLE+ and had reduction in symptoms (nz32) or were symptom free (nz14) on exclusion diet of the reacting antigen. Mucosal eosinophils/10 HPF after food reactions (CLE+ vs HC: 1-32/HPF (mean:5,78 +/- 5,6) vs 2-18/HPF (8,75 +/- 6,99)) were lower while ECP (!2-235 mg/l, mean: vs!2-13, mean 6.22) and a-tryptase (!1-31,7 mg/l, mean: 3.39 vs!1-1.57mg/l, mean 1.03) were higher in CLE+ than HC; no differences reached statistical significance. There was a trend for ECP to be significant if the number of healthy controls matched CLE+ cohort (pz 0,044). Conclusions: High concentrations of ECP in duodenal fluid with low eosinophil density in the duodenal mucosa suggests that the eosinophils have either degranulated or have been secreted into the lumen. As tryptase levels were not increased, these markers are not reliable predictors of food intolerance in IBS. Mo1618 Suspected Blood Indicator Enables Quick and Accurate Detection of Active Gastrointestinal Bleeding Samuel Han*, Julien Fahed, Daniel Kaufman, David R. Cave Internal Medicine, UMass Medical School, Worcester, MA Background: Video capsule endoscopy (VCE) allows for the detection of obscure gastrointestinal (GI) bleeding, but is often time-consuming and labor-intensive. The Suspected Blood Indicator (SBI) function on the Rapid Reader 6.0 software scans images for red pixels and may be able to detect bleeding or potential sources of bleeding. This study aims to evaluate the diagnostic accuracy of SBI in detecting active bleeding throughout the entire GI tract. Methods: 115 consecutive patients with active bleeding diagnosed by VCE were reviewed. VCE findings were evaluated for the presence of active bleeding and potentially responsible causes of bleeding. These findings were then correlated with the presence and number of SBI markers. Causes of GI bleeding determined by other modalities were also correlated with the diagnoses provided by VCE. Results: The SBI function was able to detect 100% of the 115 active GI bleeding cases documented on VCE. It was determined that 5 contiguous SBI bars had 100% sensitivity and specificity in identifying an active GI bleed. The cause of bleeding was able to be identified via VCE and other modalities in 60.7% of the cases. The most common cause of bleeding was secondary to arteriovenous malformation (AVM % of cases) with peptic ulcer disease (PUD) representing 11.8% of the cases. VCE was able to detect 75.8% of AVMs, but did not detect any Dieulafoy lesions or gastric antral vascular ectasias (GAVE). See Table 1. Discussion: In cases of GI bleeding where diagnosis via upper endoscopy or colonoscopy is difficult, the SBI function on VCE offers a quick and accurate method for detecting the presence of active bleeding. As shown in this study, 100% of active bleeds were detected by the SBI function, although VCE alone was able to offer a source of bleeding only 53.7% of the time. While overt GI bleeds will elicit a large contiguous number of SBI markers, it was determined that 5 contiguous bars are sufficient to identify active blood loss. Table 1 Final Diagnosis VCE Diagnostic Accuracy %of cases SBI markers (mean) AVM 75.8% 48.5% 15.2 PUD 50% 11.8% 41.5 GAVE 0% 10.3% 7.6 Mass 57.1% 10.3% 32.8 Dieulafoy 0% 5.9% 23.6 Varices 33.3% 4.4% 91.7 Esophagitis 33.3% 4.4% 27.0 Meckel s 100% 1.5% 11.0 Diverticulum None Identified 0% 39.3% Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB485
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