ORIGINAL ARTICLE: Clinical Endoscopy

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1 ORIGINAL ARTICLE: Clinical Endoscopy An endoscopic strategy for management of anastomotic complications from bariatric surgery: a prospective study Thierry Bège, MD, Olivier Emungania, MD, Véronique Vitton, MD, Philippe Ah-Soune, MD, David Nocca, MD, Patrick Noël, MD, Sarah Bradjanian, MD, Stéphane V. Berdah, MD, PhD, Christian Brunet, MD, Jean-Charles Grimaud, MD, Marc Barthet, MD Marseille, France Background: Treatment of anastomotic fistulas after bariatric surgery is difficult, and they are often associated with additional surgery, sepsis, and prolonged non-oral feeding. Objective: To assess a new, totally endoscopic strategy to manage anastomotic fistulas. Design: Prospective study. Setting: Tertiary-care university hospital. Patients: This study involved 27 consecutive patients from July 2007 to December Intervention: This strategy involved successive procedures for endoscopic drainage of the residual cavity, diversion of the fistula with a stent, and then closure of the residual orifice with surgical clips or sealant. Main Outcome Measurements: Technical success, mortality and morbidity, migration of the stent. Results: Multiple or complex fistulas were present in 16 cases (59%). Endoscopic drainage (nasal-fistula drain or necrosectomy) was used in 19 cases (70%). Diversion by a covered colorectal stent was used in 22 patients (81%). To close the residual or initial opening, wound clips and glue (cyanoacrylate) were used in 15 cases (55%). Neither mortality nor severe morbidity occurred. Migration of the stent occurred in 13 cases (59%) and was treated by replacement with either a longer stent or with 2 nested stents. The mean time until resolution of fistula was 86 days from the start of endoscopic management, with a mean of 4.4 endoscopies per patient. Limitations: Moderate sample size, nonrandomized study. Conclusion: An entirely endoscopic approach to the management of anastomosing fistulas that develop after bariatric surgery using sequential drainage, sutures, and diversion by stents achieved resolution of the fistulas with minimal morbidity. (Gastrointest Endosc 2011;73: ) Currently, surgery is the most effective treatment for morbid obesity, allowing substantial weight loss and a reduction in obesity-associated comorbidities. The surgical management of obesity has greatly expanded, favored Abbreviations: BMI, body mass index; NOTES, natural endoscopic transluminal endoscopic surgery. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. Copyright 2011 by the American Society for Gastrointestinal Endoscopy /$36.00 doi: /j.gie Received August 5, Accepted October 5, Current affiliations: Department of Gastroenterology and Hepatology, Department of Digestive Surgery, North Hospital, Marseille, France. Reprint requests: Thierry Bège, Department of Digestive Surgery, Hôpital Nord, Chemin des Bourrely, Marseille cedex 20, France. by the development of less-invasive laparoscopic surgery as well as a decrease in risk, which stems from the experience of specialized surgical teams and the greater frequency of bariatric surgeries. Currently, the mortality associated with bariatric surgery is approximately 0.1% to 5%, and global morbidity is 4% to 22%. 1 Anastomotic leaks are rare; in most large studies, leaks occur in 1.7% to 4% of cases. 2 Nonetheless, the current exponential growth in bariatric surgery has resulted in an increase in the absolute number of patients with anastomotic fistulas. These fistulas are important prognostic indicators, because they are associated with mortality rates ranging from 8% to 37.5%. 3,4 Management of these anastomotic complications is difficult, invasive, and prolonged. In most cases, the treatment required is surgical management, usually by laparotomy. 5 In nearly 40% of cases, 5 when life-threatening complications are not present, a conservative treatment 238 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 2 :

2 Bège et al Anastomotic complications from bariatric surgery involving no oral intake and prolonged hospitalization could be considered. 6 The maximum necessary duration of hospitalization has yet to be determined. Inspired by the preliminary success of the endoscopic management of fistulas arising after esophageal and oncological surgery, 7 some teams have used endoscopic methods (clips, glue, or stents) 8 to treat anastomotic complications of bariatric surgery. Nevertheless, few studies 9,10 describe these attempts, and the procedure has not yet been standardized. The goal of our study is to prospectively evaluate the effectiveness of the endoscopic treatment of fistulas after bariatric surgery and to establish a multimodal, endoscopic therapeutic strategy for the management of these fistulas. MATERIALS AND METHODS Take-home Message An entirely endoscopic approach by use of sequential drainage, sutures, and diversion by stents to the management of anastomosing fistulas that develop after bariatric surgery achieved resolution of the fistulas with minimal morbidity. Collaborations between gastroenterologists and surgeons should allow for the early endoscopic management of these fistulas. Between August 2007 and December 2009, all patients referred for anastomotic leaks after bariatric surgery were treated with a new strategy of endotherapy. The initial surgery occurred in our hospital for 3 cases. The other cases came from 11 centers with expertise in bariatric surgery; the patients were referred to our center secondarily for endoscopic management. Each case was discussed by a medical committee made up of a bariatric surgeon, an endoscopist, an endocrinologist, and an intensive-care physician. After discussion, a treatment strategy was planned and patients were informed of the scheduled treatment. Each patient gave informed consent. All endoscopic procedures were performed in our center by the same experienced operator, with the patients under general anesthesia with endotracheal intubation and controlled fluoroscopy. Endoscopy was performed with a large, working-channel gastroscope (working-channel diameter 3.8 mm, Hoya-Pentax, Tokyo, Japan). The endoscopic strategy included 3 successive stages. The first endoscopic procedure was the debridement and drainage of the residual perianastomotic fluid after systematic fluoroscopic mapping of the fistula (Figs. 1 and 2). The goal of this first stage was to determine the location, number, and trajectory of the fistulas. A simple fistula was defined as having a single outlet. A complex fistula corresponded to a cavity with multiple outlets or to a communicating fistula that drained into another organ (eg, an esophagobronchial fistula). In some cases, the drainage required the use of a Dormia basket (CooK Medical, Winston-Salem, NC, USA) for the debridement of necrotic tissue and/or false membranes after the endoscope was passed intraperitoneally through the fistulous opening. This procedure is considered natural endoscopic transluminal endoscopic surgery (NOTES). Copious saline solution lavage was performed, followed by an injection of amikacin (500 mg) into the cavity and the placement of a nasocystic catheter (7F, 250 cm, Liguory Nasal Biliary Drainage Set; Cook, Medical, Winston-Salem, NC, USA) (Figs. 2 and 3). Next, plastic double-pigtail stents (Cook Medical, Winston-Salem, NC, USA) were placed to complement the nasal catheter drainage (Fig. 3). Thereafter, the drains could be surgically moved or removed if they were too close to the anastomosis. The second endoscopic procedure was the diversion of the fistula (Fig. 4). Diversion was indicated when the diameter of the fistulous opening was greater than 1 cm. Covered metal colonic stents were used (Niti-S Enteral Colonic Covered Stent; Taewoong Medical, Seoul, Korea) (Fig. 4). The length varied from 100 to 180 mm, and the diameter varied from 18 to 24 mm. The proximal ends of the stents were fixed in place with clips at the level of the tulip to limit their movement. Two days after the procedure, endoscopic esophagogastroduodenal follow-through studies were performed with Gastrografin (Bayer Santé, Paris, France) to check for leaks before the reintroduction of food. Antiemetic medication was systematically administered (8 mg ondansetron, 25 mg chlorpromazine). It was projected that the stents would be necessary for 6 weeks. The third endoscopic procedure was the closure or filling of the hole. When the opening was small ( 1 cm), endoscopic suturing with endoclips (EasyClips; Olympus or Resolution; Boston Scientific, Natick, Mass) was performed. In cases involving complex fistulas, when the banks of the holes were too fibrinous or not in close proximity, we applied a synthetic glue consisting of N-butyl-2-cyanoacrylate and methacryloxysulfolane (Glubran 2; General Enterprise Marketing, Viareggio, Luca, Italy) mixed with lipiodol fluoroscopy to control its release (1 ml Glubran 2, 0.5 ml lipiodol). The average volume of cyanoacrylate used was 2 ml mixed with a 2-mL lipiodol solution. The lumen of the catheter was washed out with a 3-mL volume of lipiodol. In order to avoid endoscope damage, suction was stopped during the procedure. Successful treatment was defined as a perfect seal on a radiological examination after removal of the stent. We designated primary success as achieving a resolution in the first intervention. Secondary success corresponded to a resolution that required repetition or modification of the initial intervention. RESULTS Twenty-seven patients received endoscopic intervention for anastomotic leaks after bariatric surgery. Twenty Volume 73, No. 2 : 2011 GASTROINTESTINAL ENDOSCOPY 239

3 Anastomotic complications from bariatric surgery Bège et al Figure 1. Large perforation on the left side of the esophageal-gastric junction (an unsuccessful clip placed previously by another team is visible). Figure 4. Radiographic view showing 2 covered stents engaged in the lumen of the sleeve gastrectomy. TABLE 1. Patient characteristics Characteristic Type of bariatric surgery No. patients Gastric bypass 2 Sleeve gastrectomy 25 History of bariatric surgery 14 Initial symptom Fever 18 Pain 5 Dirty flow from wound drain 4 Figure 2. A large, infected cavity under the diaphragm was successfully treated with the NOTES procedure. Surgical rectification Laparotomy 9 Laparoscopy 11 (5 converted) No rectification 7 Method of surgical rectification Suture 7 Y inlet 1 Figure 3. A large fistula was drained through the gastric wall by doublepigtail stents and nasal catheter drainage. patients were women. The mean patient age was 41 years (range years). Three patients were obese (body mass index [BMI] ), 19 were morbidly obese (BMI ), and 5 were severely obese (BMI 50). The types of initial bariatric surgery that resulted in the leaks are described in Table 1. Fourteen cases involved iterative procedures after an initial bariatric surgery (10 ring banded surgeries, 3 Mason procedures, and 1 bypass). For 4 patients, an intraoperative incident was reported by the surgeon: stapling of the gastric tube or the disunion of the staples in 3 cases and a splenectomy for hemostasis in 1 case. On average, postoperative complications presented 6 days after surgery (range 1-72 days). The presenting symptom was not consistent (Table 1). Twenty patients (74% of cases) required surgical lavage and drainage before endoscopic management, 7 of whom required suturing of the fistula. In 15 cases, a second surgery was begun by laparoscopy, with 6 requiring conversion to laparotomy. In all cases, antibiotics were administered according to the organisms detected in cultures. 240 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 2 :

4 Bège et al Anastomotic complications from bariatric surgery TABLE 2. Endoscopy characteristics Characteristic Location of fistula No. of patients Under left cardia 21 Fundus 4 Gastroesophageal anastomosis 2 Fistula opening Individual 18 Multiple 9 Fistula outlet Simple 14 Complex 13 Stent placement 22/27 Type of stent TTS 14 Non-TTS 8 Length of stent, mm Diameter of stent, mm Migration of stent 13/22 Combined treatments Necrosectomy by NOTES 5 Nasocystic catheter drain 15 Pigtail graft 7 Glue (Glubran*) 15 Clip 15 Amikacin 14 No. of endoscopies, mean (range) 4.4 (2-16) TTS, through the scope; NOTES, natural endoscopic transluminal endoscopic surgery. *Glubran 2; General Enterprise Marketing, Viareggio, Luca, Italy. Endoscopic treatment was initiated at a median of 27 days (range days) after the initial diagnosis of a leak. For 12 patients, the endoscopy occurred in the acute postoperative period; for 6 patients, the interval between surgery and the endoscopy was more than 3 months. The fistulas are described in Table 2. Fistula diameters were larger than 10 mm except in 2 cases. Multiple or complex fistulas were present in 16 cases (59%). Among the complex fistulas, 3 were esophagobronchial and 1 was gastrocolonic. The first endoscopic procedure, debridement by a NOTES procedure of the infected cavity and/or drainage with a nasocystic catheter, was necessary in 19 of 27 patients (70% of cases) (Fig. 2). In 2 cases with fistula diameters 10 mm, a dilatation with a 12-mm balloon catheter was required to allow the passage of the endoscope. A stent was used to divert the fistula in 81% of cases (22/27 patients in the study) (Fig. 4). The characteristics of the stents are summarized in Table 2. The occlusion of the opening or a fistulous trajectory was achieved with complementary methods in 18 cases (70%). These complementary methods consisted of clips alone in 3 cases, clips and glue in 12 cases, and glue alone in 3 cases. No major complications were detected that could be attributed to endoscopy. Nine patients (33%) required stays in the intensive care or recovery units. The most common minor complication was migration of the stent, which occurred in 59% of cases (13/22 who received stents). Stent migration was remedied by replacement of the stent with a larger one or placement of a second stent nested inside the first. All the migrations were distal migrations. No distal migration caused occlusions or necessitated a second surgery. Stents were anchored by clips at the proximal part in 11 cases. Stent migration occurred in 9 of 11 cases with clips and in 4 of 11 cases without clips (P.08). Removal of the stents with clamps was not difficult and did not result in additional complications. Each stent was left in place for a mean of 27 days (range 3-59 days), and the medium total stenting time was 64 days (range days). The mean number of endoscopies per patient was 4.4 (range 2-16). The mean number of stents per patient was 2 (range 1-8). In our institution, the average hospitalization time was 32 days (range 8-82). Resolution was achieved after an average of 86 days (range days) after the initiation of endoscopic management. The first procedure was successful in 11 cases (41%). In the other cases, the leak persisted, necessitating 1 or more endoscopies to achieve resolution. Closure of the fistulas occurred at a mean of 154 days after surgery (range days). In the long term, no patient required additional operations. One patient presented with stenotic dilation because of scar tissue. The interval between the development of the fistula and the endoscopic intervention influenced the outcome (Table 3). Patients who were referred early ( 30 days; n 13) healed significantly faster (95 vs 210 days; P.005) and required fewer endoscopic sessions (average of 3.15 vs 5.57) than patients who were referred more than 30 days after presenting with symptoms of the leak (n 14). Volume 73, No. 2 : 2011 GASTROINTESTINAL ENDOSCOPY 241

5 Anastomotic complications from bariatric surgery Bège et al TABLE 3. Patient characteristics and endoscopy results by late (>30 days) or early (<30 days) referral after discovery of fistulas Characteristic DISCUSSION Late (n 14) Early (n 13) P value Sex, female/male 11/3 9/4.58 Age (y), mean Body mass index (Kg/m 2 ), mean Surgical rectification, no. (%) (79) 9 (69).58 Multiple fistulas, no Complex fistulas, no. Endoscopic drainage first, no. NOTES procedure, no. Stent placement, no No. of stents, mean Duration of stenting (d), mean No. of endoscopies Iterative procedures, no Glue, no Clips, no Success on first procedure, no. Total treatment duration (d), mean Duration of endoscopic treatment (d), mean y, year; d, day; NOTES, Natural endoscopic transluminal endoscopic surgery. For 89% of the cases in this study, a sleeve gastrectomy was the surgical procedure that caused the anastomotic leak requiring management at our institution. There are several possibilities for the prevalence of sleeve gastrectomies in our study. First, the sample for our study came from 11 surgical teams that regularly perform this procedure. The relative simplicity of this procedure compared with gastric bypass makes sleeve gastrectomy very popular among bariatric surgeons. Moreover, if the occurrence of fistulas after sleeve gastrectomy (on average 2.3% in the literature 11 ) is no higher than it is after gastric bypass, then the infancy of the procedure might be associated with a learning curve. The occurrence of a fistula also might be favored by the fact that 52% of the patients in our study had had prior bariatric surgery, a well-established risk factor for fistulas. Finally, the fistulas from sleeve gastrectomy may be less likely to heal than are the fistulas from gastric bypass with conservative management, possibly because of exposure to gastric acid. 12 The most common site of anastomotic leakage was under the left cardia, which is the uppermost region where gastric stapling occurs in sleeve gastrectomy. Studies that have reported morbidity from sleeve gastrectomy also report the same observation. 13 This site corresponds to the zone of the highest intragastric pressure, with ischemia and peristaltic dysfunction. 14 The conventional management of these fistulas involves surgical rectification. This intervention aims to flush out the fluid and drain the cavity. Suturing of the fistulas is rarely possible and often ineffective because of inflammation, as seen for the 7 patients in our study who underwent suturing. Interventional endoscopy has several theoretical advantages in these situations: endoscopy is not affected by the BMI of the patient, is less invasive than surgery, and does not induce local inflammation that can interfere with healing. Indications for this treatment, treatment modalities, and the different combinations of endoscopic procedures are not yet well-defined. Examination of the literature yielded 9 studies 9,10,14-20 for the endoscopic treatment of anastomotic leaks after bariatric surgery. Among them, only the Eisendrath et al 9 and Eubanks et al 10 studies reported more than 15 cases. Our study is the largest to date. The originality of our study stems from the fact that it corresponds to the application of a strategy that was predefined by the type of surgery. This strategy relies on the application of a sequential therapeutic program of the successive mapping of the fistula (endoscopic and fluoroscopic), debridement and drainage, diversion of the fistula, and the closure of persistent leaks. Before the first endoscopic procedures, the lesions were assessed. This exploration allowed us to determine whether the fistulas were single, multiple (9/ 27), or complex (13/27). The first stage of the endoscopy was the lavage and drainage of the residual perianastomotic fluid. Lavage was necessary in 70% of cases. If necessary, debridement and lavage with an antibiotic solution (amikacin) were performed with the NOTES procedure, passing the endoscope directly into the fistulous cavity. This type of debridement was instigated by similar procedures for acute pancreatitis with necrosis. 21 We modified our approach and combined it with a second stage of drainage by use of a double-pigtail stent and nasocystic catheter to avoid the potential for migration of the enteral stent. This stage is not currently used by other teams; 242 GASTROINTESTINAL ENDOSCOPY Volume 73, No. 2 :

6 Bège et al Anastomotic complications from bariatric surgery nonetheless, we think it reduces the time required to drain large collections of residual fluid. The second endoscopic procedure, diversion of the fistula by the placement of a covered stent, is necessary in most cases (81% in our experience). This diversion reestablishes the continuity of the digestive tract and promotes healing of the fistula by letting it dry. This was previously demonstrated by our team in cases of complete anastomotic disunion. 8 The diversion also allows for the early reintroduction of food, improving patient nutritional states and therefore favoring recovery. The third endoscopic procedure is closure of the fistula opening. The mode of repair depends on the local inflammatory conditions and on the size and number of the outlets. Closure of the outlet is rarely achieved on the first attempt. Two situations that favor a successful closure are early intervention and intervention after successful surgical drainage. Clips or glue can be used alone in conditions that are particularly favorable (single opening or shallow outlet). Another important aspect of our management strategy is its multimodal nature. Most study authors used a combination of different procedures. The combination of glue and a stent appears to be an efficacious option for the treatment of complex fistulas, particularly in cases of pleural or bronchial communication (2 cases in our study, 1 case each in the Serra et al 18 and Eisendrath et al 9 studies). We think that cyanoacrylate is better than the fibrin glue used by others 9,14,15,19,20 because it is not destroyed by gastric acid or pancreatic enzymes. No damage to the endoscope occurred with the cyanoacrylate-lipiodol solution in our series. Clips are used both to secure the stents and to close the fistulas that have shallow paths or for which paths were sealed at the same time as stent placement. However, their efficiency is not clearly demonstrated in this series, with a 59% migration rate. Repetition of the endoscopic procedures is often necessary (1-6 procedures in the Eisendrath et al 9 study and 2-16 procedures in our study), with the placement or replacement of several stents per patient (34 stents for 19 patients in the Thaler 22 study) to increase the chance of success. The duration of treatment can therefore be prolonged (86 days in our study) because of the need for repetitive procedures after an initial failure and the length of time that the stents are left in place (4-6 weeks). The results of our analysis of the literature are encouraging. The rate of success varied among published studies from 75% 17 to 100%, 14-16,20 as was found in our study. These results are from selected series of patients, with endoscopy having been indicated at the persistence of a fistula 14 or as an adjunct to surgical drainage as in either the Einsendrath et al 9 study or ours; however, our study is prospective, with the intention to treat. The morbidity of the fistulas and associated sepsis remains important, as evidenced by the need to treat 41% of our patients in a continuing care unit. However, we have not had any severe complications or deaths that were attributable to endoscopic management. In contrast, in the Eisendrath et al 9 study, 4 of 21 patients died, and in the Eubanks et al 10 study, 4 patients (16%) required surgery to rectify stent migration. In fact, stent migration was the most frequently reported undesirable event in the published studies; it was reported by all studies with a frequency that varied from 33% 15 to 83%. 19 This high incidence of migration is explained by the facts that stents are not specifically designed for this indication, they are completely covered to allow their extraction, and there is no stenosis at the location of the stent. It is for this reason that we have used colonic stents, because they are larger than esophageal stents. In our series, the use of clips did not seem to prevent stent migration. The use of long stents or 2 stents with one nested inside the other are potential means to prevent this migration; however, this has not been reported in the literature with a randomized evaluation. The use of partially covered stents could decrease the migration rate, as was shown in the Deviere s team 9 series. However, we were afraid of the potential difficulty of retrieving these stents until we read this publication of Deviere s team reporting their use of a Polyflex esophageal stent (Boston Scientific, Spencer, Indiana, USA) inside the metallic stent. This procedure induces necrosis of stent epithelial ingrowths, improving the extractability of the stent. However, we preferred to use large, colorectal stents to try to improve the tightness of the stents. Endoscopic management should be considered for all patients presenting with leaks after bariatric surgery. Endoscopy may be an adjuvant to surgical drainage if the patient s condition requires surgical rectification, and it also should be considered as an alternative to surgical management. Endoscopic treatment must be considered early, as soon as the fistula is discovered, because our results show that patients who are referred early ( 30 days) heal more rapidly and require fewer endoscopic procedures than do patients who are referred after 30 days. Endoscopic management of the leaks from bariatric surgery requires expertise in interventional endoscopy and the adaptation of existing technology. A constant dialog between surgeons and endoscopists is essential to developing the strategy for each patient. REFERENCES 1. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004;292: Podnos YD, Jimenez JC, Wilson SE, et al. Complications after laparoscopic gastric bypass: a review of 3464 cases. Arch Surg 2003;138: Csendes A, Burdiles P, Burgos AM, et al. Conservative management of anastomotic leaks after 557 open gastric bypasses. Obes Surg 2005;15: Ballesta C, Berindoague R, Cabrera M, et al. 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7 Anastomotic complications from bariatric surgery Bège et al 5. Gonzalez R, Sarr MG, Smith CD, et al. Diagnosis and contemporary management of anastomotic leaks after gastric bypass for obesity. J Am Coll Surg 2007;204: DeMaria EJ. Bariatric surgery for morbid obesity. N Engl J Med 2007;356: Hunerbein M, Stroszczynski C, Moesta KT, et al. Treatment of thoracic anastomotic leaks after esophagectomy with self-expanding plastic stents. Ann Surg 2004;240: Amrani L, Ménard C, Berdah S, et al. From iatrogenic digestive perforation to complete anatomotic disunion: endoscopic stenting as a new concept of stent guided regenration and reepithelialization. Gastrointest Endosc 2009;69: Eisendrath P, Cremer M, Himpens J, et al. Endotherapy including temporary stenting of fistulas of the upper gastrointestinal tract after laparoscopic bariatric surgery. Endoscopy 2007;39: Eubanks S, Edwards CA, Fearing NM, et al. Use of endoscopic stents to treat anastomotic complications after bariatric surgery. J Am Coll Surg 2008;206:935-8; discussion Burgos AM, Braghetto I, Csendes A, et al. Gastric leak after laparoscopicsleeve gastrectomy for obesity. Obes Surg 2009;19: Nocca D, Krawczykowsky D, Bomans B, et al. A prospective multicenter study of 163 sleeve gastrectomies: results at 1 and 2 years. Obes Surg 2008;18: 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: Casella G, Soricelli E, Rizzello M, et al. Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg 2009;19: Merrifield BF, Lautz D, Thompson CC. Endoscopic repair of gastric leaks after Roux-en-Y gastric bypass: a less invasive approach. Gastrointest Endosc 2006;63: Kriwanek S, Ott N, Ali-Abdullah S, et al. Treatment of gastro-jejunal leakage and fistulization after gastric bypass with coated self-expanding stents. Obes Surg 2006;16: 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;3:68-71; discussion Serra C, Baltasar A, Andreo L, et al. Treatment of gastric leaks with coated self-expanding stents after sleeve gastrectomy. Obes Surg 2007;17: Edwards CA, Bui TP, Astudillo JA, et al. Management of anastomotic leaks after Roux-en-Y bypass using self-expanding polyester stents. Surg Obes Relat Dis 2008;4:594-9; discussion Papavramidis ST, Eleftheriadis EE, Papavramidis TS, et al. Endoscopic management of gastrocutaneous fistula after bariatric surgery by using a fibrin sealant. Gastrointest Endosc 2004;59: Seewald S, Groth S, Omar S, et al. Aggressive endoscopic therapy for pancreatic necrosis and pancreatic abscess: a new safe and effective treatment algorithm (videos). Gastrointest Endosc 2005;62: Thaler K. Treatment of leaks and other bariatric complications with endoluminal stents. J Gastrointest Surg 2009;13: Registration of Human Clinical Trials Gastrointestinal Endoscopy follows the International Committee of Medical Journal Editors (ICMJE) s Uniform Requirements for Manuscripts Submitted to Biomedical Journals. All prospective human clinical trials eventually submitted in GIE must have been registered through one of the registries approved by the ICMJE, and proof of that registration must be submitted to GIE along with the article. For further details and explanation of which trials need to be registered as well as a list of ICMJE-acceptable registries, please go to GASTROINTESTINAL ENDOSCOPY Volume 73, No. 2 :