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Clinical Reviews

A Comprehensive Review of Endoscopic Management of Sleeve Gastrectomy Leaks

Gjeorgjievski, Mihajlo MD*,†,‡; Imam, Zaid MD*,†; Cappell, Mitchell S. MD, PhD*,†; Jamil, Laith H. MD*,†; Kahaleh, Michel MD, AGAF, FACG, FASGE

Author Information
Journal of Clinical Gastroenterology: August 2021 - Volume 55 - Issue 7 - p 551-576
doi: 10.1097/MCG.0000000000001451
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Abstract

OVERVIEW

Sleeve gastrectomy (SG) is a restrictive gastric procedure used to treat obesity. It is the most frequent bariatric surgery in the United States,1 and the second most common bariatric surgery worldwide, preceded only by Roux-en-Y gastric bypass (RYGB).2 Its prevalence has been steadily rising due to the decline in all other bariatric surgical procedures including: RYGB, laparoscopic adjustable gastric banding (LAGB) and biliopancreatic diversion/duodenal switch (BPD/DS).3 SG represents 59% of all bariatric procedures performed in 2017 in the United States.1,4

The procedure comprises vertical longitudinal resection of the gastric greater curve including the fundus, body, and antrum (Figs. 1, 2), and formation of a tubular shaped conduit with a capacity of <100 mL.5 On average, 80% of the stomach is excised, and the pylorus is usually preserved to preserve normal physiological gastric emptying.5 Historically this procedure was created as an adjunct procedure to BPD, and as a bridging procedure for weight loss before RYGB or BPD.6 However, SG is now performed as a single procedure for weight loss, without additional surgery due to the significant effect on weight loss produced by SG alone.7

FIGURE 1
FIGURE 1:
The PRISMA (preferred reporting items for systematic reviews and meta-analyses) flow diagram.
FIGURE 2
FIGURE 2:
Vertical sleeve gastrectomy.

Its popularity is attributed to its technical ease, and absence of enteric anastomosis, intestinal bypass, or external hardware.8 Lack of dumping syndrome and low incidence of marginal ulcerations are further advantages.9

Weight loss is achieved by restrictive and humoral effects of the gastric sleeve. The restrictive capacity of the gastric remnant8 decreases stomach distensibility and increases intraluminal pressure leading to reduction in bolus volume that can be accommodated.5 In addition, resection of the gastric fundus diminishes the humoral effect of ghrelin-producing cells, decreasing postprandial levels of ghrelin and promoting satiety.10 An incremental increase of glucagon-like peptide 1 (GLP-1) and peptide-YY further promotes weight loss.11

SG is positioned between RYGB and LAGB when both net weight loss and complications are considered. It produces higher net weight loss than LAGB but is associated with higher complication rates than LAGB, and produces lower net weight loss than RYGB but is associated with lower complication rates than RYGB.3,12–15 Nevertheless it provides similar short-term and medium-term weight loss to RYGB.2,16 Estimated weight loss at 1, 3, 5, and 8 years after laparoscopic sleeve gastrectomy (LSG) is 86%, 63%, 61%, and 52%, respectively,17 and at 5-year follow-up the average body mass index (BMI) is 30.2 (SD=5.5, range=0 to 60).18,19 There is also improvement or resolution of other obesity-related diseases including diabetes mellitus,20 hypertension,21 hypertriglyceridemia,22 obstructive sleep apnea,23 and nonalcoholic steatohepatitis (NASH) scores.24 On the other hand, increased intragastric pressure results in regurgitation, and reduced gastric emptying with decreased lower esophageal sphincter pressure2 lead to worsening or new onset of gastroesophageal reflux disease.17,18

COMPLICATIONS OF SG

Overall morbidity ranges from 0% to 17.5%, and overall mortality is 0% to 1.2%.14,17,25–28 At 30 days follow-up, the complications, readmission and reintervention rates position SG between LAGB and RYGB, with 5.6%, 5.4%, and 2.97%, respectively, whereas there is no significant difference in mortality.3 Similar complication rates are noted in the elderly and adolescents29–32 making SG a feasible option in these subpopulations.

Early postoperative complications include vomiting (23%), dehydration (19%), ileus (18%), bleeding (3%), and anastomotic leak (0.1%).17 According to the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Data Registry (MBSAQIP), most common complications at 30 days are anastomotic leak, bleeding requiring transfusions, urinary tract infection, and organ space infection (0.76%, 0.57%, 0.31%, 0.29%, respectively).14 Similar findings are reported in the Bariatric Outcomes Longitudinal Database 2008-2012, with most common 30-day complications being bleeding (0.5%) followed by leak (0.2%), and pulmonary embolus (0.1%).14 Gastrointestinal bleeding and leaks are complications with the largest overall impact on end-organ dysfunction, reoperation, and intensive care unit admission.33,34 Late complications include late strictures, gastroesophageal reflux disease, and incisional hernias.17,23 Leaks are the second most common cause of mortality in patients with SG, after pulmonary embolism.35,36

ANASTOMOTIC LEAKS

Definition/Overview

Leak is defined as outflow of luminal contents from a surgical anastomosis between 2 hollow viscera.37 The term leak is often interchangeably used with fistula, but there are certain differences. Leak represents a disruption of surgical anastomosis resulting in a communication between intraluminal and extraluminal (epithelialized or nonepithelialized) compartments, while fistula is an abnormal (surgical or nonsurgical) communication between 2 epithelialized surfaces.38–42 A fistula communicates externally with the skin, or internally with peritoneal, retroperitoneal or thoracic space.43 The fistula itself can epithelialize, which adversely affects spontaneous closure and treatment success.41,43,44 Chronic and untreated leak can transform and organize into fistula.41,45 Complex fistula forms when multiple fistulae are connected, arising from different organs.42 Luminal contents from both sources can cause fevers, sepsis, abscesses, and metabolic derangements. In the absence of clinical symptoms, the escape of luminal contests from the anastomotic site into an adjacent localized area detected by imaging, is defined as a subclinical leak or fistula.37

Leak development rate after SG ranges 1.85%±2.47% (median, 1.1; range 0% to 10%) based on a recent systematic review,46 and most prior studies report leak rate of <7%.3,8,9,47–53 The overall trend has been decreasing due to better recognition and prevention of potential risk factors.48,54 Most leaks occur at the proximal (cranial) location of the staple anastomosis, with 90% of cases at the gastroesophageal junction (GEJ) and angle of His (acute angle between the abdominal esophagus and gastric fundus).9,47,55–60

SG leak has a significant economic burden because it takes a long time for complete resolution (median time: 310 d; range: 9 to 546 d), and is accompanied by multiple tests, procedures, and hospitalizations.61,62 In one study from the Netherlands, median additional cost for leak was €9284 (range €1748 to 125,684), with the majority coming from hospitalization at 50%, and from ICU care at 30%.62 Another study revealed higher mean cost of €22,470.63 Interestingly, leaks are the most frequent reason for medico-legal litigation in the bariatric population, and were the legal indication in 68% of gastric sleeve patients filing a claim.64

Pathophysiology and Risk Factors

Although LSG does not involve an anastomosis, it is more susceptible to a leak than RYGB (2.4% vs. 0.7%) due to the long staple line and high intraluminal pressure.9,47,65 Multiple surgical and nonsurgical risk factors are involved in the pathophysiology and development of leak (Table 1).

TABLE 1 - Risk Factors, Pathogenesis, and Prevention of Sleeve Gastrectomy Leaks
Leak Risk Factors Mechanism for Development of Leaks Prevention
Surgical risk factors
 Stapling technique66,67 Pathologic tissue creep and shear stress Allow adequate time for tissue compression and creeping while preventing excessive tensile stress (wait 15 s before repeat firing)
 Undersized staples54,66–92 Inadequate staple formation or excessive tissue compression, exceeding tissue’s tensile strength, leading to tearing and perforation Use appropriate size staple cartridges (different colors) in different portions of the stomach
 Full thickness oversewing past a fixed staple line66 Increased risk of tearing at the point of suture penetration; latter development of strictures Consider staple-line buttressing instead (mixed results); consider use of absorbable polymer membrane or sealant; avoid oversewing and avoid use of both buttressing and oversewing
 Migratory crotch staple causing staple misfire66,67,69 Weak staple line Detect and remove the crotch staple, perform methylene blue test
 Inadvertent stapling near the angle of HIS or gastroesophageal junction47,66,67,76,93 Avoid stapling close to the esophagus in the cardia area, stay 1.5 cm away from the incisura and 1 cm away from the angle of His; perform methylene blue test
 Aggressive dissection with heat instruments35,71,76,94,95 Localized ischemia by ligation of short gastric arteries Stay 1.5 cm away from the incisura and 1 cm away from the angle of His; avoid disrupting blood supply to the proximal stomach in the cardia region
 Bougies <40 Fr in size77,96–98 Stricture development and increased intraluminal pressure Use bougies >40 Fr
 Stenosis, strictures, mechanical/physiological obstruction, sleeve angulation, spiral sleeve shape67,69,99–102 Increase in intraluminal pressure Begin the gastric transection 5-6 cm from the pylorus; maintain proper traction on the stomach before firing; use left-hand stapling; keep staple line straight while symmetrically resecting anterior and posterior walls of the stomach; keep distance >1.5 cm from the incisura
 Surgical experience, training level and number of sleeve gastrectomy performed69,81,92,103–108 Learning curve, iatrogenic factor Minimum 100 procedures under supervision; ideally supervision of initial 1000 sleeve gastrectomies; goal of >43 cases per surgeon per year; consider performing methylene blue test
 Procedural time; every additional 10 min associated with increased odds of 1-year leak109,110 Operative time as a marker for quality of care in bariatric surgery Increase and avance surgical skills, prolong training
 Surgical approach (primary or conversion)54,111,112 Procedure difficulties Attempt for laparoscopic approach; if conversion if expected, then start with primary laparotomy instead of laparoscopy (history of prior abdominal surgeries); avoid robotic sleeve gastrectomy
Nonsurgical risk factors
 Super obesity (BMI>50)9,54,113 Altered/inadequate response to incision healing and scar formation; poor blood supply; microangiopathy Weight loss before surgery
 Diabetes48,114–116 Appropriate management of hyperglycemia
 Sleep apnea48,54,116 Sleep apnea treatment
 Chronic use of steroids117,118 Taper down steroids, use lowest dose possible
 Hypoalbuminemia48,112 Preoperative dietitian/nutritionist management
 Sarcopenic obesity119 Unknown Unknown
 GERD120 Treatment of GERD
 Male gender54,56,121,122 Unknown
BMI indicates body mass index; GERD, gastroesophageal reflux disease.

Surgical Risk Factors

Sleeve stapling and suturing are a major factor in developing and preventing leaks. The different thickness of various parts of the stomach wall (with the fundus being the thinnest at 1.7 mm)123 makes use of different staple sizes important. Under-sizing staple cartridge may lead to excessive tissue compression that exceeds its tensile strength, resulting in tears and perforation.66 Full-thickness over sewing past a fixed staple-line may increase the risk of tears at the point of suture penetration in the distended gastric pouch.66 Migratory crotch staple can cause staple misfire that may not be evident immediately but predisposes to future leaks.66 Firing a staple near the angle of HIS may cause staple migration which can weaken the staple-line.

Ischemia and necrosis may contribute to leak formation, which can lead to late leaks.124,125 This frequently occurs at the angle of HIS, where take-down of the short gastric arteries leads to relative ischemia.9,55 Devascularization of this tissue with aggressive dissection using heat instruments is one mechanism that can lead to ischemic necrosis and leak formation.35

Gastric stenosis is also a major contributor to leaks. In an already noncompliant tubular stomach with an intact pylorus, stenosis, can appreciably elevate the intraluminal pressure that will exceed the strength of the tissue and the staple-line, resulting in a leak.5,65,126–128 A kink or stenosis at the incisura may predispose to an upper staple line leakage, by increasing and distending the lower esophagus and stretching the staple line just below.96,124,125 Use of smaller bougies or stapling too close to the bougie can also cause stricture by increasing retrograde pressure. In addition, twisting the staple line, causing a spiral sleeve, can ultimately result in mechanical stenosis.68

Experience of the surgeon and number of procedures performed are inversely associated with leaks.69,103,104 Leak rate <1% can be achieved in surgeons performing >43 cases per annum.104

Nonsurgical Risk Factors

Obesity is a potential risk factor for leaks, mostly in the super-obese population (BMI>50 kg/m2).9,54,113 Diabetes is also linked to higher rates of leak after gastrointestinal surgeries in some studies,114–116 but other studies failed to show an association.129 Sleep apnea and male gender were associated with higher leak rates in one study.54 Hypertension and age above 55 years at the time of surgery have been suggested as potential risk factors for development of leaks based on data in Roux-en-Y patients.35,48,113,116,121,130 Chronic corticosteroid use was associated with a higher leak rate in one study (0.6% vs. 0.3%, relative risk=2.2, P=0.03).117,118 Oxygen dependency represented an independent risk factor for leak on multivariate analysis when both RYGB and SG patients were included,48 but this was not shown when only SG patients were analyzed.131Helicobacter pylori infection does not influence postoperative outcomes in SG patients and is not associated with increased incidence of leak.132–136

Prevention

Eliminating these risk factors are necessary to prevent development of a leak and its complications (Table 1). Avoiding stapling too close to the cardia and GEJ may be effective to reduce the incidence of leaks.93 Spending adequate time for compression of gastric tissue with stapling device is also necessary to prevent a leak93,126 as well as use of different sizes of staples. Surgical factors that may decrease leak incidence include intraoperative use of fibrin sealant and staple line buttressing, but the available data are limited.66,70,93,96,97,137,138 Reinforcement of staple line with absorbable polymer membrane decreased leaks in one study.52 Oversewing did not demonstrate significant benefit.139,140

Use of ≥40-Fr bougie was associated with lower leak incidence compared with the use of bougie size <40-Fr,9,67,93,96,97,141 with the log of the bougie diameter inversely proportional to the percentage of leaks.125 Some experts believe that greater experience and high-volume centers can achieve similar success with smaller size bougies as well.142

Immediate treatment and management of functional stenosis (tissue edema, hematoma) may prevent leak formation by decreasing the pressure in the acute period. This can be achieved by nasogastric tube decompression, adequate intravenous hydration, use of intravenous antiemetics, and enteral or parenteral feeding.143,144

Intraoperative Detection of Leak

Intraoperative leak tests can identify otherwise undetectable areas of staple line disruption that prompts immediate treatment and closure to prevent further development and complications of leak.47,71,125,145–147 Nevertheless, their routine use is still debated.48,56,148–152 Most common intraoperative leak tests include: intraoperative endoscopy, air leak testing, and transgastric dye injection. Use of 100 to 150 cm3 of air to insufflate the stomach through a nasogastric tube or endoscope can be used to detect air bubbles indicating leakage.47,145,153 Methylene blue infused at the end of surgery71,148,154–156 administered via a bougie as a solution of 80 to 120 mL while the duodenum is transiently blocked with forceps, allows for accumulation in the stomach, distension of the stomach and ultimately, can reveal leakage.156

Intraoperative detection of leak decreased the incidence of postoperative leak by allowing intraoperative repair in most cases.156 Contrariwise, leak test may inadvertently damage the anastomoses and staple line. Two retrospective studies evaluating the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database revealed that the intraoperative leak test was associated with increased rates of postoperative leak.48,53 Intraoperative leak test currently remains controversial, and there is no data indicating which type of leak test is superior among methylene blue, nasogastric tube, or endoscopic air leak test.

Clinical Presentation

Clinical presentation varies widely including: asymptomatic patients diagnosed by routine imaging,156 symptomatic patients, and ultimately, patients with septic shock.157 Presentation depends on location of the leak and its onset following surgery.158 In most cases leak was not evident postoperatively, and occurred after discharge, with 50% of cases reporting leak >10 days after surgery (11 to 31 d).9 Presentation is delayed in the absence of a surgical drain postoperatively.41

Symptomatic patients present with abdominal pain (predominantly epigastric), and less commonly chest or left shoulder pain.143,158 Objective signs suggesting leak include: tachycardia, fever, tachypnea, and hypotension consistent with systemic inflammatory response syndrome. Tachycardia is a principal presenting feature in most patients,50,143,158–160 but can be nonspecific. Therefore, fever is the most important clinical factor to suggest leak143,161 and unexplained fever and tachycardia postoperatively should raise the index of suspicion for further diagnostic testing.50,125,162,163 Chronic leaks have a more insidious onset of symptoms compared with acute leaks.164

Frequently encountered laboratory abnormalities include elevated leukocyte count and c-reactive protein (CRP).143,158,165 CRP levels are elevated postoperatively and appear to peak around postoperative day (POD) 3.166 CRP levels at POD 1 <6.1 mg/dL predicts risk of leaks <2% in asymptomatic individuals.167,168 Contrariwise, persistently elevated CRP levels after POD 3 are concerning for presence of postoperative infectious complications including leaks.166

DIAGNOSIS

Most common tests used to diagnose leak include upper gastrointestinal (UGI) fluoroscopy and computed tomography (CT) scan of the abdomen with oral contrast.169 Laparoscopy is the golden standard test used to diagnose leak, but is rarely used solely for diagnosis due to its invasiveness.47,169 In a large meta-analysis, UGI series had sensitivity of 56% and specificity of 99% in diagnosing leak.170 In a head to head comparison, CT with oral contrast is superior to UGI series with a sensitivity of 95% versus 79.4%, respectively.169 Therefore, CT is considered as the best noninvasive test for detection and confirmation of leak9,56,125,143,162,165,171–173 and should be triggered by clinical suspicion.173,174 However, UGI series remains important in evaluating the location and size of leaks even after a leak is identified by cross-sectional imaging.164

There is a lack of consensus regarding postoperative use of imaging for screening and early detection of leaks.47,175,176 However, routine UGI evaluation after bariatric surgery remains a common practice in some accredited centers and is associated with prolonged hospital length of stay, without significant improvement in leak rate diagnosis.177 A selective strategy of postoperative UGI series use was found to be noninferior to a liberal strategy in terms of postoperative outcomes.176 Some authors recommend a selective postoperative use of CT scan because of its superior sensitivity.173,175

CLASSIFICATION OF LEAKS

Various authors classify leaks differently with most classifications entailing 3 major components: presence of fluid collection, onset after surgery, and location50,178–186 (Fig. 3, Table 2). On the basis of these components, further approach to leak management is designed, using adequate endoscopic, radiologic, and surgical steps.10,143

FIGURE 3
FIGURE 3:
Schematic and fluoroscopic classification of leaks. A, Type I leak, no evident fluid collection. B, Type II leak, presence of contained fluid collection. C, Type III leak, presence of uncontained fluid collection. Arrows and circles highlight the leak area and extent on fluoroscopic images. Figures obtained with permission from corresponding author, R. Chemaly.185
TABLE 2 - Classification of Sleeve Gastrectomy Leaks
Leak Classification Clinical Significance
Based on fluid collection characteristics50,178,181,182,184,185
 Type I leak50,178,181,182,184,185 (small, incidental, subclinical, asymptomatic, radiologic) Fluid collection absent. Presence of fistulous track without generalized spillage or dissemination to the adjacent cavities Does not require drainage
 Type II leak143,185,187 (large, major, clinical) Fluid collection present. More generalized dissemination into the abdominal or thoracic cavity can occur Usually symptomatic requires drainage
Contained (organized): no internal or external drainage apart from collection Consider endoscopic therapy
Uncontained (disorganized) aka Type III: presence of internal / external drainage outside the fluid collection Low threshold to consider surgical revision/management
Onset after sleeve gastrectomy40,41,68,188
 Acute Within 7 d Wall defect closure or diversion strategy more successful in this group;
 Early Within 1-6 wk
 Late After 6 wk Drainage strategy; may require ablation or abrasion of epithelial lining of fistulous tract
 Chronic After 12 wk
Location42,59,68,127,143,187,188
 Proximal Near the angle of His Difficult positioning in proximal leaks may interfere with adequate closure; may consider SEMS if unable to navigate directly to fistula orifice
 Distal Mid or lower portion of the remnant gastric tube

Presence of fluid collection and determining its containment is the most important step in classifying leaks and has a major impact on its management.185 Radiologic leak represents leak detected on imaging, without presence of localized collection and without clinical signs. It is also known as type I leak, small leak, subclinical leak, or incidental leak. The other form is called type II leak, also known as large leak or major leak, and is defined as presence of leak and fluid collection that is usually symptomatic.178 Some authors also report type III leak that recognizes a connection to the peritoneal space/skin and signifies lack of containment of the leak.185 At this point, there is no universally accepted nomenclature and various authors use different designations.178 Therefore, when defining a leak, rather than searching for an adequate designation, it is best to describe the presence of fluid collection and its containment.

On the basis of timing of onset after SG, 4 types of leaks are recognized: acute (presentation <7 d), early (presentation at 1 to 6 wk), late (presentation at 6 to 12 wk), and chronic (presentation after 12 wk of initial surgery).47,68 Classifying leaks chronologically is very important because different treatments are more effective in certain periods.189

On the basis of location, leaks are classified into 2 separate groups: proximal (near the angle of His) and distal (distally to the angle of His).68,143

OVERVIEW OF MANAGEMENT

Managing leaks has varied amongst experts and is based on personal experience. Therefore, at present there is a lack of consensus in approaching and treating leaks.35,41,55,56,94,102,125,181,185,189–201 Lack of prospective, randomized controlled trials renders guidelines more difficult, and most data come from retrospective studies, reviews, and expert opinions.125,137,187,191

A multidisciplinary approach including surgery, gastroenterology, and interventional radiology is essential to manage these complex patients.45 Prompt diagnosis, classification and treatment of leaks is essential.143,154 Delayed management on the other hand (diagnostic testing, antibiotics, and reintervention) leads to worse outcomes and is the most common reason for culpable fault in medico-legal claims of patients undergoing bariatric surgery.64

Treatment strategy depends on patient’s clinical condition and leak classification. It includes 3 mainstays: medical support, drainage of leaked material, and repair of the wall defect.35,56,144,194,199,202 Medical support entails early use of intravenous antibiotics, intravenous hydration, and nutrition.143,144,203 Antibiotics should empirically cover Klebsiella, Streptococcus, and Pseudomonas until definitive culture results are obtained.204 Addressing nutrition is a key step to enable the patient to heal the fistulous communication, and early nutrition (enteral/parenteral) is very important step in the healing process.205

Assessing patient’s clinical stability will guide further management. In the presence of hemodynamic instability, septic shock, or diffuse peritonitis, further surgical management is essential.50,171,181,206,207 For the rest, endoscopic treatment is preferred, due to high perioperative morbidity with surgery143,208 (Fig. 4).

FIGURE 4
FIGURE 4:
General principles in management of sleeve gastrectomy leaks.

SURGICAL MANAGEMENT

Surgical management of leaks is associated with significant morbidity and mortality; therefore, its use is restricted to patients with sufficient indications (hemodynamic instability, septic shock, diffuse peritonitis), and alternatives are considered for the rest.162,209,210 Nevertheless, surgical revision may have a lower morbidity than once believed, as more recent studies show better outcomes with morbidity of 5% and no mortality.211 Prompt surgical intervention requires washout, drainage, and debridement of the leak, followed by leak closure.71,125,137,212 Surgical intervention is accompanied by nothing by mouth, administration of antibiotics, and enteral or parenteral nutrition.143,144,203 Surgery may be followed by esophageal stent placement, excluding the area from further pressure and injury.66,143,181 Use of rendezvous technique has also been described where endoscopy aids in identifying the leak intraoperatively by use of a guidewire.125 Closure of the defect is less successful after POD 3 due to poor healing, presence of significant inflammation, and necrosis.9,143,213 Certain authors warn against direct surgical closure due to presence of friable and inflamed tissue with ischemic edges, making reoperation unsuccessful.171,214 Laparoscopic approach has higher success rate than laparotomy (81% vs. 43%, respectively).215

Surgical management also has a role as a step up, escalation therapy, when more conservative treatments fail.199,216 In hemodynamically stable patients a trial of nonsurgical interventions should be attempted for at least 3 months before considering surgery.47,68,188,195,217,218 Surgical approach is preferred after 6 months of failure with conservative methods, because the probability of healing following endoscopic treatment is significantly decreased (from 76.4% at 1 mo to 48.5% at 6 mo).197 Presence of loculated subphrenic collection or abscess is an independent variable associated with the need for surgical revision.188

Alternative surgical methods to primary closure include: fistula excision, fistulojejunostomy, conversion to RYGB, and jejunal patch.215,216,219–226

ENDOSCOPIC MANAGEMENT

If there are no signs of hemodynamic compromise, septic shock or peritonitis, endoscopic management should be attempted, to offer a less invasive alternative to surgery.10,47,187,227,228 Successful endoscopic therapy depends on leak onset with success of 74% to 85% in early leaks.55,197,229–231 Leaks that persist have much lower rates of endoscopic healing.197,231 In one multicenter retrospective study, endoscopic therapy achieved healing in 81 patients overall (73.6%), but the probability of successful endoscopic therapy decreased markedly with time, from 76.4% at 1 month, to 48.5% at 6 months.197 This highlights the importance of early diagnosis, since up to 80% of leaks are diagnosed after hospital discharge and >10 days after surgery.9 Predictors of successful healing following endoscopic treatment include: acute leaks developed ≤3 days after gastric sleeve, early endoscopic treatment <21 days after leak diagnosis, leak size <1 cm and absence of history of gastric banding.197

When determining the appropriate endoscopic approach for closure of luminal defects, certain fundamental principles are considered. As a short summary, the endoscopic strategy relies on the application of a sequential therapeutic program of the successive mapping of the leak (endoscopic and/or fluoroscopic), debridement and drainage or diversion (if indicated), and closure of persistent leaks192,205,232 (Fig. 5). Drainage of undrained cavities and collections should precede closure.137,203,233

FIGURE 5
FIGURE 5:
Algorithm in endoscopic management of sleeve gastrectomy leaks: a combined algorithm created on the available data and similar algorithms.35,41,55,94,102,125,181,185,192–201 TTS indicates through the scope clips.

Presence of intra-abdominal collections determines the need for drainage.216 Undrained collections should be drained externally (percutaneously) by surgical or radiologic approach, or internally by endoscopic approach.47,192,205,234–236 Rapid and adequate drainage is of paramount importance in treatment of SG leaks,45,137 because this eliminates the focus of sepsis.41 If a fistula with established epithelialized tract is present, ablation of the epithelial lining using cytology brush, endoscopic resection or thermal therapy (APC) is necessary before closure is attempted.40,42,45

The size, viability of surrounding tissue and location of the defect should be defined based on which further endoscopic closure strategy is developed.41,205,234 Finally, treatment of distal stenosis if present, and removal of foreign material (drains, staples, sutures) is important for successful treatment of SG leaks.10,233 Endoscopic management should always be performed under CO2 insufflation, which reduces risk of pneumoperitoneum, air embolization, or postprocedural patient discomfort, when compared with air.194,237 Cost-effectiveness of each endoscopic method is also an important factor that may be taken into consideration (Table 3).

TABLE 3 - Cost of Different Endoscopic Devices Used for Treatment of Sleeve Gastrectomy Leaks
Device Price* Comments
Fibrin sealant $180 May require multiple vials
Cyanoacrylate $70.00 May require multiple vials
Suturing device $910.00 May require more sutures through the same device
TTS clips $110-$370 May require multiple clips
OTS clips $440-$600 Usually closure achieved with single clip
Endoluminal stents $2000-$2500 Prices vary, multiple stents with different characteristics available
Nasocystic catheter $110
Double-pigtail stents $60 May require multiple stents
Endosponge $320 Custom made endosponge may lower price
Needle knife $190 Other devices for septotomy are also used
Cariac septal occluder $7670
TTS balloon $200
*Price in US dollar rounded to the nearest tenth. Most commonly used devices in the region are taken into consideration (not all devices and brands are included). Pricing data is based on the most recent publications, personal experience and local market and can vary significantly based on the region, contract, availability, currency, inflation, demand and many other factors. This price may not represent your supplier’s price.

ENDOSCOPIC MANAGEMENT OF ACUTE AND EARLY LEAKS

In the absence of significant fluid collection or after its drainage, acute and early leaks require treatment of the wall defect by exclusion of the defect from ongoing damage or direct closure. Treatment strategy depends on size and characteristics of the defect and expert preference. Sometimes both strategies are necessary and performed sequentially.35 Early closure can prevent further deterioration and fistula development.40

Wall Defect Closure Strategy

Direct closure of the wall defect can be attempted if the aperture is small enough without a fluid collection or after its drainage. Several endoscopic closure devices are available including: through the scope clips (TTS), over the scope clips (OTSC), tissue adhesives, tissue plugs, and endoscopic suturing devices. Appropriate use is mandated based on the size of the defect, local expertise, and endoscopist’s experience.35

Through the Scope Clipping (TTSC)

Through the scope clips are reported as a successful method to manage early leaks.238 However, the data for this particular indication are very limited.239 Clips are successful in treating small defects, especially when other methods are difficult to use due to an inaccessible location.240 TTSC use is limited by leak size, location, and endoscopist experience241 and these clips are usually used in defects <1 cm in size.44,241,242 Once the edges have been adequately approximated, the clip is deployed onto the grasped tissue, and multiple clips can be applied in parallel manner.44 Premature dislodgement of clips and inadequate sealing can occur, requiring repeat treatment.44,238,242 If the tissue is weak, friable, or necrotic, the clip may incise the mucosa without successfully approximating the edges.205,240 Commonly used TTSC include Quick Clip (Olympus America Inc., Center Valley, PA), Resolution Clip (Boston Scientific Inc., Natick, MA), Instinct Clip and TriClip (Cook Medical Inc., Bloomington, IN).242–245 Clips can be combined with other methods.239

OTSC

The OTSC achieves full-thickness closure of luminal defects.59,246–248 Studies report successful closure in 70% to 100% of SG leaks203,243,249,250 and a meta-analysis revealed overall successful closure in 67% of patients, irrespective of underlying bariatric surgery.243 OTSC can engulf a larger area compared with TTSC (up to 30 mm in size) and imitates a surgical suture in the way it performs.251,252 Suction or additional twin grasper or tissue anchor can be used to pull adequate tissue and approximate edges, by engulfing the whole leak opening into the scope.127,251,253 Predictive criteria for successful closure include early fistula (<7 d); fistulas with less fibrosis, and size 10 to 30 mm. SG leaks are more responsive to successful closure when compared with other etiologies (88.9% vs. overall 61.1%).251 Successful deployment also depends on the ability to maneuver in the narrow working space of a tubular GEJ, size and orientation of defect and surrounding tissue quality.127 Risk factors for clip failure include tissue friability, tissue ischemia, presence of infection, persistence of distal stenosis forming a high-pressure zone at the site of leakage, and difficulty obtaining adequate endoscopic position/view to deploy the clip.59,187 It is unclear whether there is any benefit of using traumatic over atraumatic clips; however, traumatic clips perform better in defects with fibrotic margins.254 Treatment efficacy is operator dependent,249,255 but delayed recurrence of leaks and fistula can occur.40,256 OTSC is significantly more efficient if prior abscess drainage is performed (88.2% vs. 53.8%, P=0.049).251 Once abscess is drained, drains must be removed before fistula closure, as long-term maintenance of drainage perpetuates the fistula.35,251 Fistulas need to be deepithelialized with a cytology brush or with argon plasma coagulation to promote granulation tissue.35 When combined with other endoscopic methods; success is achieved in up to 86% of patients.243,257 Combining OTSC with stent provides additional seal of the defect without compromising oral nutrition, and relief of the reservoir effect (collection of secretions and food that can lead to failure of healing).59,189,253,258 One retrospective study reviewed 106 patients that underwent placement of self-expandable metallic stents (SEMS) versus OTSC for endoscopic perforations or postoperative leakage. Clinical success at the end of follow-up was 46/72 (64%) versus 29/34 (85%) for patients treated by covered SEMS versus OTSC, respectively. Despite higher success with OTSC, the defects treated with OTSC were considerably smaller and there were numerous indications, therefore results of this study should be interpreted with caution.259

Tissue Adhesives and Plugs

Different tissue adhesives were used to treat leaks with data arising predominantly from RYGB patients.

Fibrin sealants contain 2 components, and when mixed, mimic the terminal phase of the clotting cascade producing fibrin monomers that subsequently assemble into a stronger cross-linked fibrin polymer.260 Fibrin sealants (Tisseel VH Fibrin Sealant, Baxter Healthcare); (Beriplast P; Aventis Behring, King of Prussia, Pa.) are used successfully in bariatric patients with RYGB or vertical gastroplasty leaks.261–265 Multiple sessions are required, and success approaches 90% to 100%.243 Fibrin sealant can be injected in the leaking lumen, but if a larger defect is present, the sealant may migrate before coagulation.137 Therefore, submucosal injection around the wall defect, can trigger local edema and narrowing of the defect.137,263 Relative contraindications to fibrin sealant include: presence of adjacent abscess, long fistulous tract and internal orifice diameter >3 cm.263,266

Cyanoacrylate (Histoacryl; B. Braun Melsungen AG, Melsungen, Germany) was used to successfully treat gastropleural, esophagopleural, and enterocutaneous fistulae.267–269 It occludes and seals the defect by rapidly solidifying on contact with weak bases such as water and blood, forming a cast.260 Percutaneous application of cyanoacrylate (Glubran2, GEM, Viareggio, Italy) via a catheter that is slowly retracted was also reported, with success of 80% in patients with adjacent endoscopic stent.270

Fibrin or cyanoacrylate sealants can be ineffective in the presence of a long fistulous tract,203 and use of sealant plugs should be attempted. Surgisis (Cook Biotech Inc., West Lafayette, IA) is an acellular matrix biomaterial derived from porcine small intestine, stimulating proliferation of fibroblasts, resulting in successful closure of leaks and fistulas.271–274 The plug can be inserted endoscopically or percutaneously in case of gastrocutaneous fistula.35 Prior abrasion of the tract using barbed instrument is recommended.35 In lack of success, sealing should be reattempted within days to week.268,271 Overall success in the studies using plugs for fistula closure in bariatric patients reached 80%.

There is one report of a novel EpiFix-dehydrated Human Amnion/Chorion Membrane (dHACM) allograft injected endoscopically to close a leak.275

Endoscopic Suturing

There are limited data on endoscopic suturing with successful closure in leaks and fistulas.276 This method should be considered in cases where defect size is significant and other methods may not be successful277,278 or when other methods failed. The success was initially reported in RYGB patients. Two cases of leaks following RYGB were successfully treated with an incisionless transoral fastening device that creates plications using polypropylene SerosaFuse fasteners; StomaphyX system (EndoGastric Solutions Inc., Redmond, WA).279 By closing the leak with suture and diverting the gastric content flow, success was achieved in each case and confirmed on repeat endoscopy 3 months afterwards.279 Use of endoscopic suturing device OverStitch system (Apollo Endosurgery Inc., Austin, TX) for treatment of leaks was successful even in patients that had failed other treatments,45,276,280,281 but the overall success rate still needs to be determined (Fig. 6). In a retrospective review, long-term clinical success was only 27% and there was no significant increase in success rate if the leak was closed as a primary or rescue therapy. Long-term clinical success was more likely if the leak was closed ≤30 days of diagnosis as compared with >30 days after diagnosis (44% vs. 0%, respectively),276 indicating its usefulness in mainly treating acute and early leaks. EndoCinch system (CR Bard, Murray Hill, NJ) was used to treat gastrogastic fistulas in RYGB patients. Complete initial closure was achieved in 95% of patients, but reopening occurred in 65% of the successfully treated at an average of 177 days, with part of the failure attributed to the absorbable nature of the sutures.282 None of the fistulas with initial size >20 mm remained closed during the follow-up period compared 32% of fistulas ≤10 mm in diameter, highlighting its use in fistulas with smaller aperture.

FIGURE 6
FIGURE 6:
Endoscopic view of full-thickness suturing device used for closure of anastomotic leak.

Given the need for considerable endoscopic expertise as well as reaching appropriate level on endoscopic suturing learning curve, this method remains exclusivity, and its unique place and role still needs to be identified.269,283,284

Wall Defect Exclusion (Diversion) Strategy

Endoluminal Stenting

Use of endoluminal stents for acute or early leaks (ie, within 6 wk after SG) is a valid and successful treatment option.10,68,182,285–290 SEMS placement is the most common endoscopic intervention used to manage SG leaks.188 These stents expand radially to its maximal diameter, allowing seal of the leak preventing influx of ongoing secretions as well as providing protection from increased pressure in presence of gastric stenosis, and by that bypassing the defect while healing occurs35,291,292 (Fig. 7). Diversion therapy offers the advantages of early oral alimentation and early discharge, reducing the likelihood of adverse events and costs associated with prolonged hospital stay.35,293–295

FIGURE 7
FIGURE 7:
Endoscopically placed fully covered self-expandable metal stent.

The clinical success rate of this procedure, which indicates complete closure of leak or fistula opening, ranges from 65% to 95%.113,203,229,232,296–303 Technical success in deploying the stent ranges from 75% to 100%.304 Data suggest that 80% of patient will require only one round of stenting to achieve clinical success,305 and overall success can be reached in 93% of patients. Prior meta-analyses regarding the use of SEMS in the treatment of postbariatric surgery leaks reported successful closure in 88% to 92% of patients, and successful endoscopic stent removal was achieved in 92% of cases, while stent migration was observed in 17% to 23% of cases.113,215,243 When compared with the other bariatric procedures, SG leaks have lower closure rates due to: larger size of the surface area requiring coverage, difficulties obtaining close apposition with the wall defect and inability to achieve water tightness.35,297 Earlier stenting is associated with higher treatment success,300 and contrariwise the longer the duration, the higher the probability of failure, correlated with development of fibrosis and a chronic fistula tract over time.294,305 Predictors for successful endoscopic stenting of leaks include: male gender, higher prebariatric surgery BMI (BMI 42 vs. BMI 38), and early stenting (25 vs. 49 d).300 Nevertheless, stent placement will not sufficiently manage any concurrent or pre-existing intra-abdominal collections.215 Presence of fluid collection is unfavorable factor in successful treatment with stents, especially when the fluid collection is >5 cm.193

The ideal stent should include anti-migratory mechanisms and should be long enough to cover the incisura/distal end of sleeve.229 The duration of stent presence ranges from 3 to 10 weeks,203,232,297–301,306–308 but some authors report success with <2 weeks of deployment.229,302 Animal studies suggest that 30 days should be adequate time for esophageal healing.309 Stent withdrawal is the only way to know if a fistula persists or has healed.292 Weekly reevaluation of the stent position may detect incipient stent dislodgement and allow easy repositioning or removal.35 Additional stent can be placed in case of stent dislodgement.296,297,310–314

Uncovered SEMS have several limitations that preclude their use in nonmalignant diseases: high risk of bleeding, recurrent strictures, erosions and tissue embedment making their removal traumatic and difficult.315–317 Therefore, covered stents (fully or partially) are currently used. Use of both self-expandable polyester (SEPS) and metal stents (SEMS) have also been reported.35,315 Covered Polyflex (polyester) and Nitinol (nickel-titanium) stents have the advantage of easy implantation and removal but the disadvantage of frequent dislodgement.71 There is less migration with partially covered Nitinol stents, and therefore decreased need for stent replacement.71,293,305,318 Most published studies are retrospective and use different types of stents.319 At this point, there is insufficient data on superiority and effectiveness of different stents in treating leaks, and the choice is left to endoscopist preference.35

Major adverse event (perforation, avulsion, stridor, fistula) rates of self-expandable stent removal after treatment of benign disease is 2.1%, while overall adverse event rate is 10.6%.320 Fully covered SEMS are more successfully removed than partially covered SEMS.320 Migration is an important limiting factor in fully covered stents, occurring in <30% of patients.113,194,239,321 Different strategies to attempt to decrease migration rates with clipping or stent suture fixation are attempted239,322–330 (Fig. 8). Mucosal in-growth at both ends of partially covered stents poses difficulties during stent removal71,293,305,331 which leads to increased risk of bleeding, mucosal stripping, and perforation.35 Stent ingrowth can also cause functional obstruction affecting the leak by increasing intraluminal prosthesis pressure.190 Stent’s radial force itself can cause localized ischemia which can prevent adequate healing and potential increase leak size.190 Rate of complications equals or exceeds 50% of cases if stents remain for more than 6 weeks.332 Therefore, complications can be prevented by removal of the prosthesis within 6 weeks after insertion, without compromising efficacy.332 In occurrence of tissue ingrowth, use of stent-in-stent technique300,331,333,334 or inversion removal technique293 can avoid need for surgical removal.335

FIGURE 8
FIGURE 8:
A, Endoscopic image of a bite through the stent. B, The proximal end of the stent is secured to the esophageal wall using the full-thickness suturing device.

Novel stents treating bariatric leaks revealed comparable success and complication rates,59,229,292,301,336,337 but some are not approved by the US Food and Drug Administration (FDA). These alternatives have high profile edges allowing a firmer anchorage, longer length bypassing entire sleeve,203,301,338 and wider diameter facilitating tight seal.339 These stents may be associated with easier endoscopic removal, and minimal number of endoscopic procedures.189,292,295,336,337,340–345 These stents include: MEGASTENT and Niti-S Beta (TaeWoong Medical Industries); HANAROSTENT (Olympus) and GASTROSEAL (M.I.Tech, Seoul, South Korea) (Fig. 9). Some authors report their use as part of combination therapy, along with external drainage.198,341 Because of large size, these stents are sometimes difficult to tolerate causing nausea, vomiting, abdominal pain, and requiring early removal. Development of duodenal bulb ulcers is also reported; where stent’s distal edge is anchored, making these stents not used as frequently.189,301,344,346 Large-scale, randomized, prospective studies to compare conventional and tailored stents are needed.203

FIGURE 9
FIGURE 9:
MEGASTENT and Niti-S Beta (TaeWoong Medical Industries). Figures taken with permission from Taewoong Medical.

Biodegradable stents were recently used with satisfactory results. They do not require repeat endoscopy for extraction, but degradation before leak closure can occur.347,348

Stenting can also be combined with some of the techniques of wall defect closure (eg, over the scope clips), but success varies, and further studies are needed to evaluate whether combined techniques are superior.59,198,341,345,349

Wall Drainage Strategy

Transfistulary stenting (discussed below) is also a feasible option used as a sole therapeutic method in patients with acute or early leaks with adjacent fluid collection not drained by other methods.187 Few studies have reported successful treatment of these leaks with the use of transgastric stents, with 90% of patients having acute or early leaks.194,350 This strategy is discussed below.

ENDOSCOPIC MANAGEMENT OF CHRONIC AND LATE LEAKS

An approach of drainage with endoscopic debridement is recommended for chronic or late leaks with or without walled off collections.10,35,237,351 Esophageal stenting and closure techniques have limited utility in this situation68,193 as leak transforms into fistula by fibrosis and epithelialization.35,299,300,352 Simple fluid collections can be drained without the need of debridement. However, presence of any foreign material needs to be removed from the leak cavity to promote healing.353–355 Dilation of the pylorus and distal sleeve is important for management of chronic leaks since presence of stenosis impedes healing and further perpetuates the leak.127,353–355 Aggressive dilation has to be carried out before or during the period of endoscopic internal drainage (EID).190

Endoscopy-assisted Debridement

When a necrotic collection develops, drainage alone may not be effective due to presence of thick solid material.187,232,235 Endoscopic or surgical debridement is required before drainage, to enable adequate drainage of the semiliquid material present.232 Endoscopic mechanical debridement follows similar principles as endoscopic debridement of pancreatic collections and can be performed using a snare, net, or basket.356,357 Dormia basket (CooK Medical, Winston-Salem, NC) has been reported as successful for debridement of necrotic tissue and/or septations.232 Saline lavage followed by injection of antibiotics (amikacin 500 mg) into the cystic cavity is reported in certain cases.232 Patients that required debridement should be supplemented by drainage of the collection after debridement.232,235

Endoscopic Transluminal Drainage

Nasocystic Drainage

Nasocystic catheter (5 to 7 Fr Nasal Biliary or 5 Fr Nasal Pancreatic Drainage Set; Cook Medical) is indicated for presence of large collection that would require repeated flushing to eliminate pus and debris.193,350 It is placed in similar fashion as for pancreatic fluid collections drainage,232,356,358,359 remains in place for 3 to 7 days356,358,359 and is usually combined with transfistulary stents.193,350 Continuous irrigation with 1500 mL saline solution per day is used in pancreatic collections, but data are limited for anastomotic collections.356 This catheter can lead to significant discomfort, especially with the use of another tube for concurrent enteral feeding.360 Also, reduction in pressure within the perigastric collection, may hamper internal drainage of material into the gastric lumen.187

Transfistulary Stenting

Transfistulary stenting, an EID is a safe first-line treatment of SG leaks with fluid collections as well as a salvage treatment when other endoscopic techniques fail.35,214,350,361,362 However, other methods can achieve internal drainage as well, making this term confusing. Some authors have adopted transfistulary stenting as the only endoscopic modality of treatment of leaks after LSG.190,291 Clinical success varies in the range of 70% to 85%.190,215,350,362,363 In a systematic review including 11 studies with total of 681 patients, successful leak closure was noted in 85% when used as a first-line treatment and 78% as a rescue therapy.363 Their success was reported in both acute/early and chronic/late leaks.193,194,350

Using double-pigtail stents, leak drainage is achieved similarly as pseudocyst drainage. The stents keep the fistula tract between the gastric lumen and the infected paragastric space open, with progressive reduction of the collection and conversion into a “virtual” cavity that is only occupied by pigtail loops.35,350,364 In addition, the pigtail stent can potentially act as a foreign body in the dead space, promoting tissue granulation190,194 and reepithelialization.35,194,291 Plastic double pigtail stents (7 to 10 Fr Zimmon or Solus, Cook Medical; 7 to 10 Fr Advanix, Boston Scientific; 8.5 Fr Endo-Flex, Voerde) are endoscopically placed alone or along with a nasocystic catheter.350 Some authors believe that nasocystic catheter should be avoided long-term because it reduces interluminal pressure, slowing down internal drainage.187 Therefore, external drains and nasocystic catheter should be removed, or used solely for intermittent flushing while remaining clamped during the interim period.187 The double-pigtail stent is left in situ, to facilitate the continuous outflow of the remaining necrotic and purulent material and is exchanged every 4 to 6 weeks until the fluid collection is completely drained.190,194,356 Some authors advise against routine stent exchange unless necrosectomy is also performed.187 Removal should be performed as soon as clinical/radiologic resolution is seen.187 Occasionally, a small residual cavity resembling pseudodiverticulum may form at the end of the drainage process without any clinical significance, and not requiring closure.187,194,365 If cyst orifice is not clearly identified, endoscopic ultrasound can assist in drainage, just like pancreatic pseudocysts.35,189,194,214,366,367 This method reduces the need of external drainage (surgical/radiologic), thus reducing interval time between diagnosis and treatment, complications, and costs.195 Patients with a unique and well-circumscribed collection are good candidates for this treatment, but complex disorganized, multiple, or uncontained leakages may resist internal drainage and require surgical intervention.187,350 Transfistulary stenting for noncontained collections should be supplemented by external drain that led to 93% success at 1-year follow-up by one study.195 This approach needs to be compared to surgery alone.195 Aggressive dilation of downstream stenosis is required to reduce intragastric pressure and ultimately, reverse pressures with spontaneous drainage of the debris into gastric lumen.187,194,196,368,369 Oral nutrition is recommended since the pressure gradient should keep food away from the perigastric cavity.187 In cases of severe gastric stenosis where high intragastric pressure is present or in presence of large leak orifice >1 to 2 cm where pigtail stent migration is imminent, placement of a fully covered stent with or without double pigtail stent may be the appropriate strategy.196,369 Over the scope clip has been successfully used as an adjunct to transfistulary (transluminal internal) drainage, as a final closure of the leak after drainage with double pigtail stent for 4 to 6 weeks.291 Mean leak healing time is 118 days (range: 5 to 227 d), which may deter endoscopists from its routine use and may render this method economically not feasible.291,363,368 Common complications include stent migration into the perigastric cavity or gastric lumen and ulcerations in the gastric wall.190,291,350,370,371

A retrospective study compared closure/diversion and internal drainage strategies for treatment of chronic leaks. Closure/diversion strategy involved placement of covered metal stent and/or clipping or glue. Internal drainage strategy involved placement of double pigtail stent within the cavity with or without nasocystic drain. Higher leak resolution was achieved in patients undergoing internal drainage compared with patients undergoing closure/diversion (86% vs. 63%, respectively). Patients that failed closure/diversion also underwent EID, with a success rate of 82%.193 In addition, transluminal stenting may be more cost-effective compared with covered stents (€20,024 vs. €24,916; P=0.018, in one study).63

Vacuum-assisted Closure/Drainage

Endoscopic vacuum-assisted closure (EVAC) is a technique where endoscopically inserted sponge absorbs fluid leading to rapid control of sepsis, reducing risk of contamination/superinfection, and accelerating formation of granulation tissue.203,206,372–377 It uses the same principles described in open vacuum-assisted wound closure.378 Rapid and significant decline in leukocytosis, CRP levels and APACHE II score was noted after vacuum-assisted closure, confirming rapid control of sepsis by efficient drainage of infected wound cavity.372 In case of failure, endoscopic vacuum therapy (EVT) does not jeopardize surgical repair.206 EVAC is considered as first line and salvage therapy in patients who fail other endoscopic methods.40,379

Endo-SPONGE system (B. Braun Melsungen AG, Melsungen, Germany) or an open pore polyurethane sponge (VivanoMed Foam, Paul Hartmann AG, Heidenheim, Germany) has been used.206,380 The sponge can be inserted in the cavity (intracavitary vacuum therapy) in accessible leakages with a large opening (≥9 mm), or at the level of the esophageal wall defect (intraluminal vacuum therapy), if the orifice is too small to accommodate the sponge.360 The sponge is connected to an external vacuum device through a nasocystic or nasogastric catheter (Fig. 10). Suction is applied using a continuous negative pressure of 70 to 125 mm Hg.206,360,372,380 After 2 to 5 days, cavity is reevaluated, and sponge replaced until cavity is closed or the wound cavity becomes small, contained, and lined by granulation tissue.374,375 This technique results in negative pressure at the leak site, necessitating a feeding jejunostomy or total parenteral nutrition.187 Mean number of sponge insertions in one study was 6, where sponges were changed every 3.5 days.381 EVAC may be combined with placement of endoluminal stent to improve vacuum force and maintain esophageal passage,374,382 or in the presence of persistent wall defects despite drainage.380

FIGURE 10
FIGURE 10:
A, Sponge and nasogastric catheter used for endovacuum therapy. B, Vaccuum therapy of an anastomotic leak cavity with the sponge fully inserted into the cavity and its proximal end extending in the esophagus.

Its clinical success ranges from 84% to 100%,360,372,375,380,383,384 but data are limited and come from treatment of nonbariatric and non-SG leaks and perforations.360,372 In SG leaks, successful closure has been documented in early and late leaks, with time interval between bariatric surgery and endoscopic treatment of 32 and 61 days, respectively.375,383 Two retrospective studies comparing EVAC to endoluminal stenting in esophageal leaks revealed success of 84% and 93% versus 54% and 63%, respectively.360,385 Another study revealed lower mortality using EVAC compared with stenting.386 These are retrospective studies of endoscopic closure of esophageal intrathoracic leaks and need to be evaluated cautiously.

The need for multiple endoscopic procedures and prolonged hospitalization stay makes EVAC treatment challenging,189,206,360,374 with some studies reporting success after average of 50 days EVAC therapy.375 Preprocedural preparation with placement of a suitable sponge can be time consuming, but procedure duration improves rapidly with increasing experience.206,360 Preassembled EVT sets for the upper GI tract fitting different cavities and endoluminal diameters are increasingly offered commercially, further reducing processing time.206 In addition, the erosive effect of the vacuum can cause severe hemorrhage if placed adjacent to vascular structures, but this was reported in 2 cases, and the underlying significance and correlation needs to be determined.360,372,387 Nevertheless, its use needs to be weighted carefully in cases of close contact to major thoracic or abdominal vascular structures.206 Once case of pancreatitis was reported, correlating it to the EVT.375

Septotomy/Fenestration

Septotomy or fenestration is a technique of cutting the pseudoseptum between perigastric cavity and gastric lumen using needle knife, cutting knife, or APC probe, to facilitate drainage.55,200,289,353–355,388–395 It addresses the pressure gradient that drives gastric contents from the lumen into perigastric collection, and by completely exposing the leak cavity, it equalizes the interluminal pressures391 (Fig. 11). This technique acts like endoscopic treatment of Zenker’s diverticulum and allows healing by secondary intention and epithelialization.55 It is only performed if a septum between perigastric cavity and gastric lumen is identified.41 Sleeve dilation is required in presence of downstream stenosis or axis deviation,41,200 which reduces intragastric pressure. Bleeding occurs more frequently with the needle-knife technique due to lack of coagulative effect.55 APC generates high current densities and effectively ablates the septal tissue, while simultaneously coagulating the margins to limit bleeding.55 On the basis of the available case reports and case series, its effectiveness approaches 100%. Sometimes repeated septotomy is required, and some cases require up to 11 attempts, with average number of procedures of 2 to 5.55,354,355 Repeated therapy is performed as necessary, with more pseudoseptum being cut each time.187

FIGURE 11
FIGURE 11:
A–C, Septotomy technique; A, there is a perigastric cavity, septum, and distal pouch. Cavity must be washed and cleaned (upper set). B–C, Septum is incised to allow communication between both cavities (upper set). A–C, The cut should not exceed the bottom of the cavity (lower set). Figures taken with permission from corresponding author G. Baretta.354
Cardiac Septal Occluder Device

Cardiac septal occluder (CSDO) device was recently reported to successfully treat chronic and late leaks.233 Amplatzer CSDO (St. Jude Medical, Plymouth, Minn) is a shape-memory, self-expanding double-disk (double umbrella) closure device made of nitinol and interwoven polyester, which promotes in-growth while sealing the fistula tract.396 These features may allow approach to fistulas with irregular margins, epithelialized tracts, and edematous or scarred tissue.396 The device can reposition as needed before final deployment, and even then, can be removed endoscopically, reassembled and placed again, until final satisfactory position is achieved.233 Attempts to treat acute and early leaks is less successful and recurrence of leaks are common, requiring replacement and upsizing of the occluder. Overall treatment success was 62% for acute/early leaks and 97% for late/chronic leaks.233 Presence of late and chronic leaks is a significand predictor of treatment success.233 More studies are needed to define size and type of occlude device, length of fistula that can be closed and potential adverse events. Since this represents an occlusion device, drainage of adjacent fluid collection based on the principles described above is still necessary.233

Sparse case reports have also identified the success of ventricular or atrial septal occluder or vascular plug use in different types of gastrointestinal leaks and fistulas with similar mechanism of action.387,397–421

DILATION OF DISTAL STENOSIS

Postoperative stenosis is a known complication of bariatric surgery203 with incidence of 1% to 4%422–424 and a major contributing factor to leak development.5,126 Its incidence is reported as 0.5% to 3.5%.9,46,424,425

Incisura angularis followed by GEJ are sites with greatest stenosis potential.77 Stenosis typically occurs due to calibration of the sleeve over a tube that is too narrow or oversewing of the staple line.77 Two types are recognized in the literature. Functional stenosis (helix stenosis) is abnormal rotation, kinking and twisting of the sleeve, with the ability of the endoscope to traverse the stenosis.67,101,102,426 In mechanical stenosis, passage of the endoscope is difficult or impossible67,102 due to overtraction of the greater curvature during stapling or hematomas that may organize into scar tissue.67 The elevated intraluminal pressure due to stenosis is a major contributing factor to a higher leak rate,5,126 therefore prompt identification and treatment is essential.

Postoperative imaging does not predict development of stenosis, as initial normal appearance of the sleeve is frequently observed.101,427–432 Therefore, if suspicion of stenosis is present, prompt endoscopic evaluation and treatment is required, since early endoscopic treatment (within 90 d after surgery) is more effective than late, which may lead to revisional surgery.203,433 Current treatments for sleeve stenosis include: balloon dilation and endoluminal stenting.

Since the introduction of through-the-scope (TTS) endoscopy, endoscopic balloon dilation of stenoses became established as an effective and safe therapeutic tool.203 Some require repeat dilation, ranging from 2 to 4 sessions and even up to 7 sessions (Fig. 12). The success rate which indicates resolution of obstructive symptoms and passage of the endoscope without disturbance exceeds 90% in proximal and 70% in distal stenoses.203,423–434 However, serious complications including perforation are reported in 2% to 5% of cases. Long-segment stenoses that do not respond to endoscopic techniques may ultimately require conversion to RYGB.424 Controlled radial expansion balloon (Boston Scientific Corporation, Marlborough, MA) is effective when dilated 15 to 20 mm in diameter for most strictures.77,424,435 However, a larger, achalasia balloon dilator Rigiflex II Balloon (Boston Scientific),425,434 is required in cases of treatment-refractory strictures.77,425,436 Gradual increase in balloon size by 5mm every third dilation (max of 40 mm) has been adopted as a protocol for treatment of these stenoses.423 Other experts reported success with endoscopic needle cuts in four quadrants after dilation for refractory patients.426

FIGURE 12
FIGURE 12:
A and B, Barium study images illustrating gastric sleeve stenosis (upper set). A, Intraoperative view of a classic axial deviation at the level of the incisura angularis (lower set). B, Endoscopic view of the dilated sleeve with a 30 mm achalasia balloon (lower set). Figures taken with permission from corresponding author R. Pescarus.422

Placement of a stent at the stenosis site is another option that can treat both stenosis and leak simultaneously.47,293,295,310,425,437,438 It can be used along balloon dilation as well.425 The principles of stent placement are described above. It remains uncertain which method is more effective, and most recent data suggest that endoluminal stents and pneumatic dilation are more effective than TTS balloon.436

CONCLUSION

Leaks remain a major complication of SG and are associated with significant morbidity, prolonged hospital stay, and surgical failure. Successful management requires close collaboration between the bariatric surgeon, gastroenterologist, interventional radiologist, infectious disease specialist, and nutritionist.

Every case should be addressed uniquely based on clinical presentation, location, complexity and onset. Despite this, some general rules need to be applied: commencement of early intravenous hydration, antibiotics, and nutrition. With presence of fluid collection, successful drainage is required before attempting or during endoscopic treatment.

In the absence of septic shock or clinical instability, endoscopic management should be attempted for a minimum of 3 to 6 months. At this point there are sparse data to favor specific endoscopic methods, and the approach depends on leak location, onset, and personal experience. Closure and diversion strategies are predominantly reserved for acute and early leaks, while internal drainage strategies are used mainly for late and chronic leaks. The latter can be performed in early leaks as well, if a fluid collection is present and percutaneous drainage was not attempted. In the presence of distal stenosis, treatment with balloon dilation or stenting is required to facilitate healing and prevent leak recurrence. Ultimately, unsuccessful endoscopic treatment of leak after 3 to 6 months requires surgical revision.

As the popularity of SG grows, it is important that all gastroenterologists be familiar with this procedure and its complications since its management is mainly driven by the gastroenterologist and their endoscopic capability. Success rates in tackling SG leaks depends on the center’s expertise, and such cases should be managed at centers with high volume and expertise in endoscopic techniques and surgical revisions to minimize morbidity and improve outcomes.

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                              Keywords:

                              endobariatric; sleeve gastrectomy; bariatric surgery; endoscopic suturing

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