BRIGHAM AND WOMEN S HOSPITAL HARVARD MEDICAL SCHOOL

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1 BRIGHAM AND WOMEN S HOSPITAL HARVARD MEDICAL SCHOOL Bariatric Surgery Patient and Endoscopic Treatment Christopher Thompson MD, MSc, FACG, FASGE Director of Therapeutic Endoscopy Division i i of Gastroenterology t Brigham and Women s Hospital Harvard Medical School Sept. 2011

2 Agenda Bariatric Basics Endoscopic Repair of Surgical Complications New Endoscopic Paradigm

3 Obesity Obesity is a metabolic disease Venus Figurine 3300 BC Severe toll of comorbid illness Obesity more prevalent hunger Ruben s Bacchus ( ) Daniel Lambert Portrait C.1800 Underserved group that requires a multidisciplinary treatment approach

4 Obesity Class BMIKg/m Underweight 18 Normal Overweight Obesity I Obesity II Obesity III >40 Qualify for surgery BMI 35 with co-morbid illness BMI 40 NIH Consensus Conference,1985 NIH Clinical Guidelines pub# , Sept 1998

5 Pathophysiology Obesity is complex and multifactorial We don t understand mechanisms of action for obesity treatments Surgery likely hit multiple mechanisms

6 Diets esa and Medications edca Have Limited Efficacy 3-5% of dieters can maintain weight loss for 5 years Medication can achieve better weight loss than diet and exercise alone (3-5 kg), but with high rates of attrition (30-40%) Mann T. et al. American Psychologist 2007;62(3): Padwal RS, et al. Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD004094

7 Bariatric Surgical Approaches Lower Morbidity / Lower Risk Less Effective Higher Morbidity / Higher Risk More Effective

8 Morbidity 23-77% 5-10% early PE, resp failure, bleeding, infection, ulceration, bowel obstruction, bt ti leaks 15-40% late ulcers, strictures, stasis, nutritional, hernias, and fistula Mortality % Morbidity 5-20% Pouch dilation 4% Ulceration 4% Migration 1.6% Band erosion 1.7% Port migration / abscess Mortality 0.22%

9 Gastric Bypass Revision Open Revision Early morbidity 15 to 50% Emergent re-operation in 5% Mortality 2% Similar late complication rates Laparoscopic Revision Technically challenging / arduous learning process Conversion rates as high as 48% reported More complications i requiring i early surgery vs. open revision i Requires in-patient hospital stay Brolin RE. S Clin NA, 2001; Behrns KE et al, Ann Surg. 1993; Khaitan L. Am J Surg 2005; Gagner M et al, Obesity Surgery.2002; de Csepel J, et al. Surg Endosc. 2001; Sugarman et al. Am J Surg, 1984

10 Endoscopic Evaluation Preparation Require high doses for sedation Difficult airway Obstructive sleep apnea Pulmonary hypertension Anesthesia Consult

11 Normal Gastric Bypass Anatomy

12 Complications Anastomotic Ulcers Strictures Band Complications Fistulae and Leaks Weight Regain

13 Anastomotic Ulcers Incidence: Diagnosis % EGD Most common source of Pouch PH delayed hemorrhage H pylori fecal antigen Most Treatment common first 3 months postop Soluble PPI, sucralfate, remove contributory factors (NSAIDs, H pylori, Etiology: acid, fistula, NSAIDs, tob) H. pylori, ischemia, FB removal FB reaction Surgery Sapala JA, et al. Obesity Surgery 1998;8: Gisbert JP, et al. AJG 2006;101:

14 Risk factor for marginal ulcer (MU) in a logistic regression model (100 MU and 90 controls) Risk factors Univariate Analysis Multivariate Analysis Odds Ratio [CI] P Value Odds Ratio [CI] P Value Years from Surgery 0.8 [ ] < [0.7-1] Diabetes 2.5 [1.1-6] [1.8-18] Smoking 2.5 [1.5-5] [0.9-7] NSAID use 0.9 [0.4-2] [0.1-1] 0.04 Inhaled steroid use 2.3 [1-5] [0.8-12] 0.1 SSRI use 0.7 [ ] [0.4-3] 0.8 Gastric pouch length 12[10315] 1.2 [ ] [116] 1.3 [1-1.6] Abu Dayyeh, B. et al. DDW 2011

15 Postoperative Hemorrhage 15%incidence 1.5% Small series looking at endoscopic of early treatment post- of acute gastric postoperative bypass p hemorrhage hemorrhage Endoscopy in under 24 Slightly hours safe more Slightly more common with laparoscopic approach Injection therapy Source typically at staple line Clips Fernandez-esparrach G, et al. Gastrointest Endosc Mar;67(3):552-5 Tang SJ, et al. Obes Surg Sep;17(9):1261-7

16 Complications Anastomotic Ulcers Strictures Band Complications i Fistulae and Leaks Weight Regain

17 Clinical Stricture Case Don t Over Dilate! Etiology: ulceration, 35 More Sites y/o of aggressive female stenosis 3 years and post- RYGB ischemia, endoscopic band complication incidence with gastrojejunal approach anastomotic Circular Remove Gastrojejunal j suture staplers stricture. anastomosis material OR She 11.3 Treatment underwent Inject 4-19% saline 5 sessions / steroid of balloon Passage through Balloon Consider dilatation needle-knife mesocolon dilation with 66-93% 0-2% short duration incision successful, of response 2-3 sessions (3 weeks Jejunojejunal often at required best). anastomosis Revision 0-2% surgery Durable has Up resolution been Gastric to band but not exceeding of recommended. 0-2% symptoms 15 mm was on first achieved She treatment now presents Adhesions (later) 0-2% after FB two for second opinion. removal sessions of Next suture steps? removal, injection, and Surgical dilation revision Peifer KJ, et al. GIE 2007;66:

18 Complications Anastomotic ulcers Strictures Band complications i Fistulae and Leaks Weight Regain

19 Band Erosion Incidence 2% Due to inflammatory reaction Symptoms Severe pain, nausea, emesis Treatment Endoscopic removal Surgical revision Different approach required

20 Clinical i l Case 48 Steps Abdominal y/o for female adjustable CT who showed had obesity gastric foreign band body surgical removal in in mexico jejunum Must have in and partial Now presents small erosion bowel with and be able to abdominal obstruction. see buckle pain on Findings endo and question suggestive Surgical of removal of recent migrated of GI port bleeding. adjustable / tie off tubing No gastric records are band. Pass available. Jag wire thru band Apply mechanical lithotriptor Remove with snare

21 Complications Anastomotic ulcers Strictures Band complications Fistulae and Leaks Weight Regain

22 Leaks Initial Define Internal management anatomy fistulae Radiologic 87% Bowel rest drainage Average 2 to 5 sessions Control leakage TPN Fistula to peritoneum Overall success rate 75 Staple line dehiscence Low complication rates Tissue Esophago-pleural preparation pleural Factors associated with Mucosal stripping poor Esophago-mediastinal outcome Fistuloscopy with d b id Large Other opening (>1cm Tissue apposition 2 ), Correction of electrolyte and fluid abnormalities Treat Infection Entero-cutaneous? Octreotide with debridment short tract (<2cm), distal Clipscutaneous obstruction, persistent Octreotide infection, Endoscopic high output suturing (>200cc per day) Tissue adhesives (fibrin glue, plugs, matrix) Diversion Other etiology Stents Malignant, (duct radiation, stents and luminal stents) Crohn s Rabago, LR Endoscopy 2002, 34;632 Merrifield B, et al. GIE ; Lang, V Surgical Endoscopy 1990, 4;212

23 Leak Meta-analysis analysis Author Year of Publication No of Patients Type of Stent Fukumoto et al Polyflex stent Babor et al Ella Boubella Esophageal Stent Eubanks et al Alveolus and Polyflex Stents Serra et al Hanarostent and Polyflex Stent Eisendrathet et al Ultraflex and Silky Esophageal Stent Salinas et al Ultraflex Stent Casellaet et al Ultraflex and NITI S Esophageal Stent Puli S, et al. DDW 2010

24 Forest Plot Showing Proportion of Leak Closure with SES Puli S, et al. DDW 2010

25 Gastrogastric Fistula Incidence Conservative 95 patients t with 0-29% mgmt GGF Etiology Avg PPI 2.2 sutures placed Mechanical Nutritionist 95% initial closure rate Emesis 65% re-open at avg 177 days Staple gun failure Ischemia Fistula < 1 / cm ulcers predicts better Inflammation response with durable closure in over 30% (mean f/u 395 days) Acid reflux No fistula over 2 cm Epigastric pain remained closed Jejunal ulceration Stricture Weight regain Complications Fernandez-Esparrach G, et al. SOARD 2010 May-Jun;6(3):282-8.

26 New Larger Clips

27 Clinical i l Case 40 year old female 5 years post-rygb with iron deficient anemia and heme positive stools Normal EGD and colonoscopy Capsule study normal Next steps?

28 Accessing the PB Limb Standard enteroscope Challenging Length of Roux limb Acute angle of JJ anastomosis Alternate t techniques Double balloon enteroscope ShapeLock enteroscope Spirus Surgical assistance

29 Complications Anastomotic ulcers Strictures Band complications Fistulae and Leaks Weight Regain

30 Revision: Weight Regain after RYGB Sjostrom L, et al. NEJM 2007 Aug 23;357(8):

31 Revision: Weight Regain after Mechanisms not clearly understood Hormonal changes Dietary noncompliance Alteration in gut flora Anatomic considerations Surgical revision carries high rate of morbidity and mortality RYGB

32 Gastrojejunal stoma diameter is associated with weight regain after RYGB Abu Dayyeh, Lautz, and Thompson. Clin Gastroenterol Hepatol Nov 16.

33 Diagnosis i Careful history Dietary indiscretion? Soft calories? Nutrition consult UGI series Fistulae Endoscopy Stoma / pouch size Length of Roux limb

34 Endoscopic Solutions for Dilated Anastomosis Sclerotherapy Suturing Devices LSI ESD Bard EndoCinch EES Spiderman USGI IOP Endogastric Solutions StomaphyX Apollo OverStitch Thompson C. DDW AB, 2004 Schweitzer M, et al. J Lapendo Adv Surg Tech (4):

35 Spaulding, et al. Anastomosis Reduction: 20 of 20 patients achieved diminished size of gastrojejunostomy to 10 mm 15 of 20 patients achieved 9%EWL at 6 months Abu Dayyeh, et al. 231 consecutive patients 575 sessions of ST 36% weight regain from nadir Avg pre-op stoma size 19mm Avg 2 session (1-3) Avg 16 cc injected per session Sclerotherapy Spaulding L Obes Surg 2003;13:254 Abu Dayyeh, et al. DDW 2011

36 Sclerotherapy: BWH Mean 10 Lb 95 th CI [ ] 17% of weight gain Mean 26 Lb 95 th CI [ ] 61% of weight gain (lb)

37 Sclerotherapy: BWH

38 Sclerotherapy: :BWH Total number of sclerotherapy sessions: 575 Gastrointestinal perforation 0 Admissions i for post procedural abdominal pain 3 (0.5%) Bleeding Stopped spontaneously Epinephrine i injection Epinephrine and endoscopic clipping 14 (2.4%) Transient diastolic blood pressure elevation > 105 mmhg > 25 mmhg from pre procedure reading 64 / 425 (15%)

39 Revision: RESTORe We eight (kgs) Weight Loss Over Time (PP) Double blind Sham controlled 2:1 randomization 359 screened 129 enrolled 77 randomized 6 Wk 3 Mo 6 Mo % EWL at 6 months DGJR: 15.9 ±20.9 Sham: ±20.18 DGJR (n=42) Sham (n=27) p=.044 Thompson CC, et al. DDW 2010 Gastroenterology 2010;138(5):S-388.

40 Obesity Treatment Options Low Effectiveness Revision Bridge Low Risk Diet/ Drugs Endolumenal Endolumenal Bariatrics? Bariatrics Primary Therapy High Risk VBG Early Intervention Lap Band Metabolic High Effectiveness Sleeve Gastric Gastr. Bypass BPD/DS

41 Early Intervention: Spectrum of Care Non-invasive Minimally invasive Surgical Orthopedics Exercise / PT Meds Arthroscopy Joint replacement Cardiology Exercise / Diet Meds Angioplasty CABG Obesity Exercise / Diet Meds Endoscopy Banding, RYGB

42 Early Intervention: Endolumenal l Suturing Endoluminal TRIM l Vertical Trial Gastroplasty %EWL for Subjects % Excess s Weight Lo oss Completing 12M Follow-Up 64 patients, 12 mo f/u 60% 50% 40% 30% 20% 10% 0% Procedural time 45 min 20% %EWL at 1, 3, 12 mo 21.1, 39.6, No complications Months Post Procedure 12M (n =14) BMI < >40 (Kg/m 2) %Excess Weight Loss Thompson Fogel C, R. et GIE al. DDW 2008 Jul;68(1): M1259

43 Metabolic: Implantable Sleeves ange from Ba aseline (%) HbA1c Ch DJBL Week 12 Sham Week DJBL Week 24 Sham Week Randomized (n=8) 12 (n=3) blinded (n=9) pilot 24 (n=4) 0 study (N=18) sleeve sham week follow-up -2.5 Endpoints -3 Primary HbA1c point glucose profile Weight OAD loss medication - no sig change use between Wihtl Weight groups loss p> % off OAD meds v. 17% sham Weight loss Rodriguez L, et al. Diabetes Technol Ther Nov;11(11):725-32

44 Conclusion Obesity is a major health concern that requires multidisciplinary care Bariatric surgery is being performed more frequently and GIs will continue to see complications of surgery Gastroenterologists should better integrate into bariatric centers of excellence and start taking a more active role in caring for these patients

45 BRIGHAM AND WOMEN S HOSPITAL HARVARD MEDICAL SCHOOL Bariatric Surgery Patient and Endoscopic Treatment Christopher Thompson MD, MSc, FACG, FASGE Director of Therapeutic Endoscopy Division i i of Gastroenterology t Brigham and Women s Hospital Harvard Medical School Sept. 2011