Successful Management of Refractory Staple Line Leakage at the Esophagogastric Junction After a Sleeve Gastrectomy Using the HANAROSTENT

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1 DOI /s CASE REPORT Successful Management of Refractory Staple Line Leakage at the Esophagogastric Junction After a Sleeve Gastrectomy Using the HANAROSTENT Takashi Oshiro & Kazunori Kasama & Akiko Umezawa & Eiji Kanehira & Yoshimochi Kurokawa Received: 16 May 2009 / Accepted: 1 September 2009 # Springer Science + Business Media, LLC 2009 Abstract The esophagogastric junction (EGJ) is a potential site of leakage after a sleeve gastrectomy which is usually difficult to treat conservatively. Two patients underwent a laparoscopic sleeve gastrectomy. A subphrenic abscess due to a staple line leakage was detected by CT at 3 weeks and 10 days after the operation, respectively. The abscess was drained laparoscopically. Intractable leakage required several endoscopic treatments, including clipping and sealing. However, a persisting fistula was found on radiographic studies. A covered self-expandable and retrievable stent (HANAROSTENT ) was finally placed over the leakage site at 15 and 6 weeks after the reoperation, respectively. Oral intake was achieved from poststent day 1, and they were discharged 2 weeks after stenting. Three months later, the stent was endoscopically removed and the leakage was successfully sealed. The HANAROSTENT is therefore considered to be a safe and effective therapeutic option for the management of staple line leakage at the EGJ. Keywords Staple line leakage. Sleeve gastrectomy. Esophagogastric junction. HANAROSTENT Introduction A sleeve gastrectomy is thought to be a simpler and safer operation in comparison with malabsorptive operations which include enteric anastomosis. Leakage along the staple line at the esophagogastric junction (EGJ) is difficult T. Oshiro (*) : K. Kasama : A. Umezawa : E. Kanehira : Y. Kurokawa Minimally Invasive Surgery Center, Yotsuya Medical Cube, Tokyo, Japan t-oshiro@dc5.so-net.ne.jp to treat but common complications of sleeve gastrectomy [1]. Drainage is required when the abscess around the leak is recognized by computed tomography (CT) scanning. Conservative treatment is ineffective for leakage itself in most cases. Additional endoscopic procedures such as combination of clipping and fibrin glue injection or stent placement are usually needed to close a leak site [2 4]. This study reports two cases of refractory staple line leakage at the EGJ after a sleeve gastrectomy which could be successfully treated with a self-expandable and retrievable stent. Materials and Methods Indication The indications for bariatric surgery in obese patients, based on the statement of the consensus meeting for Asian people, are a BMI>37 kg/m 2 or BMI>32 kg/m 2 with diabetes or two other obesity-related co-morbidities [5]. Laparoscopic bariatric surgery is routinely performed including Roux-en-Y gastric bypass, sleeve gastrectomy (LSG) and adjustable gastric banding in Japan [6]. An LSG is indicated for the treatment of morbidly obese patients with a relatively low BMI, high risk of gastric cancer such as those positive for Helicobacter pylori, to avoid the risk of enteric anastomosis and/or as the first of a two-stage procedure for the high risk and the super-obese patient. When the patient has type 2 diabetes requiring insulin therapy or expects greater weight loss, a duodenal jejunal bypass (DJB) is recommended in addition to a sleeve gastrectomy (LSG/DJB) [7]. Eighty-five LSG or LSG/DJB procedures were performed from July 2006 to July 2009, in this department.

2 beginning on postoperative day 2 (POD2) for at least 4 weeks. Once the patient is able to maintain hydration, then the patient is discharged. The mean length hospital stay is 3 to 4 days. Patient 1 Fig. 1 CT shows subphrenic fluid collection along the staple line (white arrow) Surgical Technique Patients are positioned with their legs split in the reverse Trendelenburg position. The surgeon stands on the right side of the patient. The first 12 mm trocar is introduced in the midline, 15 cm caudal from the xyphoid utilizing a nonbladed optical trocar system. Four additional trocars are inserted under direct vision. Pneumoperitoneum is established to 15 mmhg, and a 30 angled scope is used. After full mobilization of the greater curvature up to the angle of His, the gastric sleeve is constructed using repeated firing with a linear stapler over a 36 or 45 Fr boogie from the distal antrum (6 cm from the pylorus) to the His angle. In case 1, the first gastric transection at the antrum and final transection at the fundus were performed using a 60-mm green or blue load MULTIFIRE ENDO GIA stapler (Tyco Healthcare, Japan) armed with bioabsorbable NEOVEIL staple line reinforcement material (Gunze, Japan), respectively. At this point, the duodenum was divided using a 60-mm blue load linear stapler with NEOVEIL 1 cm distal to the pylorus. Therein, a two-layer hand-sewn duodenojejunostomy was created with 3/0 absorbable sutures (biliopancreatic limb 50 cm; alimentary limb 150 cm). In case 2, the gastric resection was completed without NEOVEIL, and the staple line was over-sewn with non-absorbable sutures. The specimen is removed from the 15-mm trocar site. Endoscopy is used to check for any stenosis, leakage or hemorrhaging, and the drain is, thereafter, put alongside the staple line. A 29-year-old female with a BMI of 48 kg/m 2 underwent an LSG/DJB. Although the patient required a transfusion of eight units of packed red blood cell due to intra-abdominal and subcutaneous hemorrhaging, she recovered without a reoperation and left the hospital on POD4. Three weeks after the operation, the patient was rehospitalized due to abdominal pain and a high fever. CT showed left subphrenic fluid accumulation (Fig. 1). Unfortunately, CTguided drainage could not be performed at our institution because of the lack of an experienced radiologist. As a result, the patient was treated laparoscopically to drain the subphrenic abscess. Due to the fact that the patient strongly refused enteral feeding via a nasogastric tube, she was therefore treated conservatively with a restriction of oral intake and total parenteral nutrition for 3 weeks. However, the introduction of oral intake increased the amount of drainage. Seven weeks after the reoperation, the first postoperative endoscopy detected an orifice of a fistula at the EGJ consistent with the staple line, and then, the orifice was closed with several clips. This did not achieve adequate control of the leakage so the patient underwent two additional endoscopic procedures including argon plasma coagulation with a setting of 40 W, fibrin glue injection and clipping. However, the persistent leakage finally required the placement of a covered self-expandable and retrievable stent (HANAROSTENT, diameter 22 mm, length 90 mm, M.I. Tech., Seoul, Korea; Fig. 2). Stenting was performed by endoscopy and fluoroscopy under general anesthesia 15 weeks after the reoperation (Fig. 3). Postoperative Care Gastrograffin swallow is administered on the first postoperative day (POD) to evaluate the gastric volume and to exclude postoperative leaks before the initiation of oral intake. The patient is given oral proton pump inhibitors Fig. 2 HANAROSTENT consists of a membrane, gold radiopaque markers, an antireflux valve at a distal end and a retrievable lasso attached to proximal end

3 Fig. 3 a Endoscopic view after stent placement. The orifice of the fistula was closely covered with a membrane. b Stent deployed at the leak site (white arrow) Patient 2 A 27-year-old male with a BMI of 39kg/m 2 underwent an LSG. He had an uneventful course and was discharged on the third postoperative day. However, he experienced a high fever and was readmitted to the hospital 10 days after the surgery. A CT scan revealed fluid accumulation around the angle of His (Fig. 4a). He also underwent a reoperation laparoscopically. Although intraoperative endoscopy did not show any evidence of staple line leakage, the upper staple line which was the presumed leak site was covered with the omentum and drainage tubes were put in place. A gastrograffin swallow examination revealed minor leakage at the site of the angle of His on POD 4 (Fig. 4b). Endoscopy revealed leakage at the EGJ; then, the orifice was closed with several clips. However, the uncontrolled staple line leakage required additional endoscopic treatment including argon plasma coagulation, cyanoacrylate injection and clipping. Those procedures also failed to sufficiently control the leakage, and a HANAROSTENT was finally put in place, as described for patient 1, 6 weeks after the reoperation. Results Oral intake started with clear liquid on poststent day 1 and then progressed to a soft food and eventually, a normal diet. After the drainage tube was removed, they were discharged from the hospital 2 weeks after stenting. Both patients could tolerate the stent with acceptable symptoms including nausea, occasional vomiting and mild epigastric pain. Stent dislocation and migration were not seen during the followup period. The stent was removed endoscopically 3 months later by pulling a retrieval lasso with forceps. The removal of the stent was easy. There was no adherence of the stent or mucosal ulceration after removal (Fig. 5). The orifice of the fistula was, thereafter, completely closed. CT with oral contrast also showed no evidence of any leakage. Discussion Although an LSG is thought to be associated with fewer complications, leakage from the staple line at the EGJ occurs in about 1.6% of cases [8]. Early leaks, in the 24- to Fig. 4 a CT reveals a sizable amount of fluid accumulating near the EGJ (white arrow). b Gastrograffin swallow showed leakage at the EGJ

4 Fig. 5 a Stent after removal. b Endoscopic view showing complete closure of the fistula 48-h postoperative period, may possibly be treated with laparoscopic suturing. After that time, drainage at the site of leakage and conservative management were the cornerstones of the treatment. For persisting fistulas, some authors suggest endoscopic clip application, fibrin sealing or stent placement [2 4]; however, no uniform methods have yet been established. Endoclipping at the orifice of the fistula became ineffective in a few days. Endoclipping a fistula at the EGJ is difficult due to the fragile orifice and tangential direction and is frequently unsuccessful. Although animal studies have indicated that mucosal ablation before tissue apposition promotes tissue healing [9]; treatment with a combination of argon plasma coagulation of the fistula, sealant injection and clipping also proved to be ineffective. Papavramidis et al. said the key to the successful closure of the fistula is repetitive gluing by an experienced endoscopist at 2 3-day intervals [3]. However, repeated sealing was not performed because the patient in the first case could not undergo endoscopic treatment without general anesthesia. In addition, the correct application of glue sealing can sometimes be difficult. The adherence of the sealant plug to the tip of the injection catheter is therefore a crucial problem at this procedure. Retrievable stents such as Polyflex (Boston Scientific, USA) or HANAROSTENT (M.I. Tech, Korea) are an alternative option for closing intractable leakage [4, 10]. Unfortunately, those stents are not available in Japan. It took several weeks to obtain institutional review board approval and import the HANAROSTENT from Korea. Because there is little consensus regarding the ideal size of such stents, the stent size in our cases was finally determined after referring to Serra's report [10]. The stent placement was very effective for reducing the fistula output, and oral intake was resumed successfully the day after stenting. The stents were placed in the proper initial position, and there was no stentrelated trouble requiring treatment while the stents were in place. HANAROSTENT is also an inexpensive instrument, with the regular price being about $1,200 which is only about double cost of endoscopical treatment in Japan. Stenting with HANAROSTENT may therefore be a less invasive and cost-effective procedure which may also shorten the patient's hospital stay. Both HANAROSTENT and Polyflex are covered self-expandable and retrievable stents that are useful in the treatment of staple line leakage. However, migration is a fundamental concern with the use of removable stents. Polyflex requires clips and silk sutures to secure the stent in place despite the presence of a proximal flare designed for improved stent fixation [4]. Meanwhile, the HANAR- OSTENT has two unique features for anti-migration with larger bands on both ends and a segmented structure. Since both ends of the stent have larger bands, the stent can be fixed within the esophagus. In addition, the unique segmented structure minimizes the effect of outside pressure on the overall stent body while increasing the flexibility of the stent under peristaltic motion. Even if the stent slips distally, the stent can be adjusted to the proper position using the lasso attached at the proximal end with forceps. The traction on the stent causes the stent to elongate as it is pulled proximally. Furthermore, the HANAROSTENT has an anti-reflux valve at the distal end in order to prevent gastroesophageal reflux. Gastroesophageal reflux disease seems to be an annoying complication which sometimes occurs after a sleeve gastrectomy in the early postoperative period [11]. This stent could therefore be an effective treatment for patients demonstrating staple line leakage following a sleeve gastrectomy. The EGJ is usually the site of a leak after an LSG [1]. Particular attention should be paid in this area at the time of staple firings. It is important to use staples of an adequate height and to avoid stapling the esophagus. There is no consensus with regard to the need for reinforcement of staple line with buttressing material or over-sewing [12 14]. Nevertheless, the use of an absorbable polymer membrane (Seamguard, Gore) to reinforce the staple line is widely prevalent in the bariatric surgery

5 field. The buttress material strongly holds staples and thus possibly decreases leaks at the staple line [14]. In Japan, NEOVEIL, which is made of polyglycolic acid and characterized by unwoven felt, is the only approved absorbable reinforcement material. This is mainly used for reinforcement of the staple line during lung resection. Although this material was used during the early period LSG, including the first case, the occasional misfiring of linear cutting stapler at the antrum changed this policy. An endoscopic stapler armed with NEOVEIL may not be adequate for transecting the thicker portions of the stomach such as the antrum or EGJ. Currently, the staple line is reinforced by a seromuscular running suture with non-absorbable thread. Conclusion Care must be taken during final firing of the linear stapler near EGJ to avoid postoperative leakage. Once leakage occurs, a covered stent can initiate early per oral nutrition and expedite healing of symptomatic staple line leakage thereby reducing the cost and length of hospital stays. The current experience suggests that HANAROSTENT is suited for the treatment of leakage at the EGJ by virtue of its unique structure to prevent migration. References 1. Dapri G, Vaz C, Cadière GB, et al. A prospective randomized study comparing two different techniques for laparoscopic sleeve gastrectomy. Obes Surg. 2007;17(11): Akhras J, Tobi M, Zagnoon A. Endoscopic fibrin sealant injection with application of hemostatic clips: a novel method of closing a refractory gastrocutaneous fistula. Dig Dis Sci. 2005;50(10): Papavramidis TS, Kotzampassi K, Kotidis E, et al. Endoscopic fibrin sealing of gastrocutaneous fistulas after sleeve gastrectomy and biliopancreatic diversion with duodenal switch. J Gastroenterol Hepatol. 2008;23(12): Fukumoto R, Orlina J, McGinty J, et al. Use of Polyflex stents in treatment of acute esophageal and gastric leaks after bariatric surgery. Surg Obes Relat Dis. 2007;3(1): Lee WJ, Wang W. Bariatric surgery: Asia-Pacific perspective. Obes Surg. 2005;15(6): Kasama K, Tagaya N, Kanahira E, et al. Has laparoscopic bariatric surgery been accepted in Japan? The experience of a single surgeon. Obes Surg. 2008;18(11): Kasama K, Tagaya N, Kanahira E, et al. Laparoscopic sleeve gastrectomy with duodenojejunal bypass: technique and preliminary results. Obes Surg (in press) 8. Deitel M, Crosby RD, Gagner M. The first international consensus summit for sleeve gastrectomy (SG), New York City, October 25 27, Obes Surg. 2008;18(5): Felsher J, Farres H, Chand B, et al. Mucosal apposition in endoscopic suturing. Gastrointest Endosc. 2003;58(6): Serra C, Baltasar A, Andreo L, et al. Treatment of gastric leaks with coated self-expanding stents after sleeve gastrectomy. Obes Surg. 2007;17(7): Akkary E, Duffy A, Bell R. Deciphering the sleeve: technique, indications, efficacy, and safety of sleeve gastrectomy. Obes Surg. 2008;18(10): Kasalicky M, Michalsky D, Housova J, et al. Laparoscopic sleeve gastrectomy without an over-sewing of the staple line. Obes Surg. 2008;18(10): Chen B, Kiriakopoulos A, Tsakayannis D, et al. Reinforcement does not necessarily reduce the rate of staple line leaks after sleeve gastrectomy. A review of the literature and clinical experiences. Obes Surg. 2009;19(2): Consten EC, Gagner M, Pomp A, et al. Decreased bleeding after laparoscopic sleeve gastrectomy with or without duodenal switch for morbid obesity using a stapled buttressed absorbable polymer membrane. Obes Surg. 2004;14(10):