Techniques in Gastrointestinal Endoscopy (2010) 12, 141-145 Techniques in GASTROINTESTINAL ENDOSCOPY www.techgiendoscopy.com Treatment of leaks and fistulae after bariatric surgery Sohail N. Shaikh, MD, Christopher C. Thompson, MD Division of Gastroenterology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts. KEYWORDS: Bariatric surgery; Gastric leaks; Fistula; Complications; Endoscopic repair; Roux-en-Y Gastric leaks are an ominous complication following Roux-en-Y gastric bypass associated with a high mortality. Surgical revision is often complicated and not without risk. Several series have brought to light endoscopic interventions that may play a role in the management of these patients. This paper provides an overview of the surgical approach to this difficult problem and outlines several endoscopic approaches to gastric leak and fistulae management, including stents, clips, fibrin glue, and endoscopic suturing. © 2010 Elsevier Inc. All rights reserved. Treatment of leaks and fistulae after bariatric surgery Gastric leaks have been studied since the early 1800s when a French Canadian hunter suffered a musket shot injury, allowing William Beaumont to record some of the earliest work in this regard. Despite his efforts, he was unable to quell the “food and drinks . . . unless prevented by a tent, compress, and bandage.”1 Modern-day medicine has advanced since this early work; however, gastric fistulae and leaks are still difficult to manage. Leak rates vary by type of surgical intervention with large series reporting 2.05% to 5.20% for laparoscopic Roux-en-Y gastric bypass (RYGB) and 1.68% to 2.60% for open RYGB.2,3 Similarly, sleeve gastrectomy has an associated leak rate up to 5.1%, although the size of these studies is limited in comparison.4-6 With the associated mortality of leaks and surgical revision, endoscopic management is attractive because it may offer treatment with a more favorable risk profile. Surgical anatomy RYGB anatomy creates several sites at risk for leak/ fistula: (1) gastrojejunal anastamosis, (2) jejunojejunostomy anastamosis, (3) gastrogastric staple line, or (4) gastric Address reprint requests to Christopher C. Thompson, MD, Division of Gastroenterology, Brigham and Women’s Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA. E-mail: cthompson@hms. harvard.edu 1096-2883/10/$-see front matter © 2010 Elsevier Inc. All rights reserved. doi:10.1016/j.tgie.2010.10.003 pouch staple line (when transected from the remnant stomach). The most common sites for RYGB leak are at the gastrojejunal anastamosis, followed by the jejunojejunostomy anastamosis with an associated mortality of up to 18.4% and 40%, respectively.7 Of note, the isolated stomach may be stapled in continuity or transected, thereby decreasing the chance of gastrogastric fistulae. Laparoscopic stapling devices typically divide and transect the stomach, whereas open bypass procedures traditionally divide the stomach with staples without transection. Additionally, staple leaks are among the most common complications following sleeve gastrectomy. These leaks usually occur at the proximal border within 2 cm of the angle of His, with a large survey of surgeons reporting a 0.2% ⫾ 0.9% mortality.6,8 Symptoms/diagnostics Leaks may occur in the immediate postoperative period up to months later. Although no standard exists, current literature generally refers to early as ⬍1 wk and late any time beyond that period. Early leaks typically manifest constitutional symptoms within 3 d and may be difficult to diagnose. In a case series of 63 RYGB leak patients, Gonzalez et al reported early symptoms of tachycardia, fever, and abdominal pain in most patients; however, less than onethird had purulent drain output, oliguria, and hypotension.10 Additional signs and symptoms include shoulder pain, hypoxia, leukocytosis ⬎10,000/mm3, and an elevated C-reactive protein ⬎11 mg/L.6,9 Diagnostic modalities may not be 142 Techniques in Gastrointestinal Endoscopy, Vol 12, No 3, July 2010 helpful because a computed tomography scan was diagnostic in only 56% of patients, with 30% of leak patients having both a negative barium swallow and a computed tomography scan. The high mortality associated with leaks coupled with the paucity of reliable diagnostic symptoms and poor specificity of imaging mandates clinical vigilance. The threshold for early exploration is low where lack of improvement usually prompts surgical reintervention.10,11 Chronic leaks may develop with similar constitutional symptoms or as a less toxic insidious process with abdominal pain and fever. Gastrogastric fistulae (GGF) are a nonurgent complication defined as a communication between the pouch and defunctionalized stomach. Typical presenting symptoms include reflux, heartburn, epigastric pain, weight fluctuations, and ulcerations.12-15 Endoscopic therapy of these less morbid complications may play an important role to mitigate the considerably high morbidity and mortality of surgical revision.10 Endoscopic approach Several endoscopic techniques have been used, many of which attempt to adhere to basic surgical principles. Stents, mucosal ablation with biological adhesives and clips, suturing, and other novel devices have shown promise to address gastric leaks and fistulae. These methods typically address the treatment of chronic leaks, following appropriate management of the initial septic period, and GG fistulae. they were poorly tolerated. The recent advent of covered esophageal metal stents has allowed their temporary use in a variety of conditions, with several case reports and a few case series demonstrating utility for management of postbariatric surgery leaks.21-26 Stents serve as a useful adjunct to drainage, creating enteral diversion, and may allow oral nutrition. Additionally, the less invasive nature of endoscopic therapy may convey a decrease in cost and possibly a mortality benefit compared with conventional surgical management. Using partially covered self-expanding metal stents (pSEMS) in postbariatric surgery leak patients, Eisendrath et al reported an overall 81% closure rate (n ⫽ 17/21), with stent duration of 2 mo and a median follow-up of 221 d (range, 61-544 d). Complications included stent migration, bleeding, and thoracic pain.21 Eubanks et al used pSEMS and self-expanding plastic stents to heal 89% of acute leaks (n ⫽ 11) and 50% of chronic leaks (n ⫽ 2), with an average stent duration of 20 d and a mean follow-up of 3.2 and 6.5 mo, respectively.22 Further studies by Blackmon et al used pSEMS for successful treatment of 10 gastric bypass leaks, 5 acute and 5 chronic.26 An additional study by Tan et al reported 50% resolution in 8 patients with sleeve gastrectomy leaks using pSEMS with 4 successful fistulae closures after 6 wk of stent placement.8 Enteral stent complications for postgastric bypass leaks include bleeding, pain, migration, and management of tissue hyperplasia. Bleeding in the above studies was managed endoscopically. Complications in both reports were similar to that observed in other studies and include an approximate 25% stent migration rate.22,23,25,27-29 Future postbariatric anatomy-specific stent designs may help mitigate migration rates. Stent placement requires the use of fluoroscopy and a forward-viewing endoscope. Deployment precautions include ensuring adequate distance from the upper esophageal sphincter to avoid globus sensation and length must be carefully chosen to prevent distal enteral wall impaction because this may lead to bleeding and possibly perforation. Removal or repositioning may require the use of a doublechannel endoscope with forceps or graspers. Additionally, if tissue hyperplasia is present APC may be necessary for tissue fulguration; alternatively, some studies have demonstrated the utility of an additional stent placement (stent within a stent) to induce tissue necrosis with subsequent withdrawal of the stents in tandem.8 Although currently esophageal stents are not approved for gastric fistula management and further studies are need, the data are compelling. Unfortunately, these studies did not address fistula/leak size, which may have an impact on outcome.30 Furthermore, because some studies rely on adjunctive endoscopic therapeutics, including APC, tissue sealants, and multiple stent placements, the healing rate of stents alone is difficult to discern. Esophageal stents Tissue adhesive Esophageal stents have traditionally been used for palliative purposes. Initially, plastic stents were used; however, Several tissue adhesives have been advocated to aide wound healing.31 Fibrin sealant is biocompatible and bio- Management Tenets of leak management include sepsis control (including antibiotics, drain management, abscess detection, exposure, and drainage), adequate nutrition, appropriate skin care, monitoring fistulae output, and anatomical definition.9,16,17 Further steps to improve healing include enteral feeding, alleviation of downstream strictures, and minimizing fistula exposure to alimentary contents.12 Surgical approach Leaks may be treated nonoperatively when clinically warranted with antibiotics, drain management, abscess drainage, enteral/total parenteral nutrition, or nil per os. Reports have shown 23 of 26 and 5 of 5 patients with successful conservative management when classified as “low risk.”6,10 Alternatively, with early signs of sepsis, regardless of definitive evidence for leak, the threshold for early surgical reintervention is low. This is because of the high associated mortality rate, paucity of specific symptoms, and frequency of negative diagnostics seen with postsurgical leaks.6,8-10 In consideration of the high reoperative morbidity and mortality and technical difficulty in this surgical population, alternative endoscopic methods of leak control have been explored.18-20 Shaikh and Thompson Treatment of Leaks and Fistulae after Bariatric Surgery degradable and has been used for a variety of surgical procedures to prevent wound dehiscence and has been used intraoperatively to prevent postbypass leaks.32,33 As a group, fibrin sealants are not associated with the inflammatory response and tissue necrosis inherent to other sealants, such as cyanoacrylate.34,35 Since its early use in 1909 by Bergel as a hemostatic agent, fibrin glue has gained popularity.36 Currently approved for hemostasis, skin graft attachment in burn patients, and colostomy closure,37 fibrin glue has been used off label for esophageal leaks and gastrointestinal fistulae.31,38-40 Fibrinogen and thrombin combined with calcium and factor XIII use the terminal coagulation cascade to form a fibrin clot that may allow for cellular migration, promote angiogenesis, and support tissue repair with keratinocyte and fibroblast growth.35,41 Additionally, similar to enteric bypass afforded by endoscopic stents, fibrin clots may prevent extravasation of luminal contents as shown in a pig study by Bonanomi et al where fibrin clots consistently occluded anastomotic leaks with documented gastric pouch leak healing.42 With the high morbidity of leaks and reoperative bariatric surgery, the prospect of a noninvasive method for leak management seems attractive. The endoscopic approach involves fistula identification, removal of overlying granulation tissue when possible, and subsequent excoriation or mucosal ablation prior to sealant application. The sealant is endoscopically placed using a dual lumen catheter that allows the admixture of components at the distal tip, resulting in a whitish fibrin plug. Instillation of the fibrin glue may prove challenging because fibrinogen and thrombin have different viscosities. Additionally, care must be taken not to inject while inside the endoscope channel or withdraw the catheter as the sealant is extruded because this may clog the channel; however, scope damage is less likely than that associated with cyanoacrylate. Cessation of flow is best achieved by applying negative pressure to the syringes. Several publications have extolled the value of endoscopic gastric leak management with fibrin glue. In a recent study reviewing 354 laparoscopic RYGB, Kowalski et al encountered 8 gastric leaks, 5 of which were successfully treated with fibrin glue.40 Several other small series and case reports have shown efficacy as well. Merrifield et al described the use of fibrin glue in the resolution of a gastropleural fistula using 7 mL of fibrin glue after RYGB.43 Papavramidis et al demonstrated healing after complicated gastroplasty surgery using 1 and 6 sessions of fibrin glue in 2 cases of gastrocutaneous fistulae44. Shand et al reported a case of fistula repair using absorbable mesh with fibrin glue after traumatic gastric feeding-tube removal.45 AvalosGonzalez et al and Hwang and Chen demonstrated shorter healing times using fibrin glue in comparison with a conservative approach in various gastrointestinal tract fistulae.46,47 Rabago et al reported an 86.6% success rate using fibrin glue for fistulae management; however, this study included several portions of the gastrointestinal tract.39 Although limited prospective comparative data exist and most published literature groups various types of fistulae, 143 endoscopic instillation of fibrin glue or other biological adhesives will likely play an important role in the management of gastric fistulae and leaks. Because prior studies have addressed factors associated with lack of fistulae closure, such as actinic or neoplastic tissue, further work is necessary to identify characteristics that favor fibrin glue therapy.13,48 Furthermore, this application should be reserved for nonseptic patients because operative therapy for unstable/nonimproving patients is the mainstay of treatment for gastric leaks. Mechanical tissue manipulation Suturing Technological advances in endoscopy have produced suturing platforms that may allow intraluminal management of complications previously treated by laparoscopic or open surgery. One type of fistula amenable to endoscopic suturing is gastrogastric fistula. GGF have a reported incidence in RYGB of up to 49% (when the stapled pouch and remnant are in continuity or only partially transected), with lower rates described in laparoscopic procedures where transection is typical. RYGB-associated GGF may occur as a result of stapler failure, vascular compromise, ulceration, or incomplete transection of the remnant stomach. Patients typically present with reflux, epigastric pain, weight fluctuations, and ulceration.12-15 Because revisional surgery carries a relatively high mortality and management of fistulas may be technically difficult, endoscopic therapies have been attempted. Fernandez-Esparrach et al reported the use of endoscopic clips or suturing in conjunction with mucosal ablation and fibrin glue to promote the closure of GGF in 95 RYGB patients.30 Although initially successful in 90% of cases, overall long-term success for fistula closure was 19% at a median follow-up of 359 d. Although further studies are needed to better identify which subset responds best to endoscopic suturing, Fernandez-Esparrach et al were able to demonstrate that fistulas ⬍10 mm in diameter were most responsive.30 There are no large series that have reported the use of suturing devices in the treatment of postsurgical leaks. Endoscopic clips Clips have been used with variable efficacy for gastrointestinal tract defects, although limited data are available for bariatric management of gastric leaks and fistula.30,49,50 Currently available through-the-scope clips achieve superficial tissue apposition engaging the mucosa and submucosa (with 1.2-mm-wide ⫻ 6-mm-long arms capable of approximately 12-mm grasp) and have been used in conjunction with mucosal ablation and fibrin glue to aid in the closure of fistulae.30,49,51 Recognizing the shortcomings of current clips, further developments have led to an over-the-scope clip. Iacopini et al demonstrated the use of this over-thescope clip in the management of persistent (2-wk) gastrocutaneous fistulae measuring 10 mm and ⬍15 mm with good healing.52 With traumatic and atraumatic versions, this large clip seems attractive for inducing higher compressive 144 Techniques in Gastrointestinal Endoscopy, Vol 12, No 3, July 2010 forces with larger tissue purchase. Further studies are needed, however, to demonstrate the efficacy and durability of fistula closure. Other novel devices Post-RYGB stomal reduction equipment has found utility in closing gastric fistulae. The use of StomaphyX (EndoGastric Solutions, Inc, Redmond, WA, USA), initially purposed for stomal reductions, has been reported with regard to the treatment of postbariatric fistulae. Overcash et al, reported the successful use of the device in the management of 2 patients with a 7.6-mm and 1.0-cm fistula using 5 and 6 polypropylene fasteners to create pleats of gastric tissue surrounding the defect forming a “tissue shield” with follow-up at 6 and 3 mo, respectively, confirming fistulae healing.53 Other endoscopic devices are under development for gastric tissue manipulation that may aid fistula closure; however, these devices are in various stages of research and require further investigation. 5. 6. 7. 8. 9. 10. 11. 12. Conclusions 13. Because obesity is becoming more prevalent in our society, the number of bariatric procedures is likely to increase, as will the associated complications. One of the most ominous complications is gastrointestinal leak. Management depends on clinical presentation and requires treatment of sepsis, nutritional support, abscess detection, appropriate drainage, fistulae monitoring, skin care, and frequently invasive measures. Revisional surgery has a high morbidity and mortality and is usually technically difficult. In patients with clinically stable presentations there may be a role for noninvasive endoscopic therapies with a more attractive risk profile. These include clips, fibrin glue, and newer modalities, such as endoscopic suturing, stent placement, modified clips, and polypropylene fasteners. Currently, the best evidence exists for stents, despite the relatively high migration rate. Many other modalities are in their infancy and need to be vetted in a rigorous manner with comparative prospective studies to identify factors that may affect fistula healing. Despite more questions than answers at this time, endoscopic therapy for gastric leak management holds promise and will likely become an integral component of the management algorithm for the treatment of bariatric surgery complications. 14. References 1. Rutkow IM: Beaumont and St Martin: A blast from the past. Arch Surg 133:1259, 1998 2. 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