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BACKGROUND: Leaks are considered one of the major complications of laparoscopic sleeve gastrectomy (LSG) with a reported rate up to 7 %. Drainage of the collection coupled with SEMS deployment is the most frequent treatment. Its success is variable and burdened by high morbidity and not irrelevant mortality. The aim of this paper is to suggest and establish a new approach by endoscopic internal drainage (EID) for the management of leaks. METHODS: Since March 2013, 67 patients presenting leak following LSG were treated with deployment of double pigtail plastic stents across orifice leak, positioning one end inside the collection and the other end in remnant stomach. The aim of EID is to internally drain the collection and at the same time promote leak healing. RESULTS: Double pigtails stent were successfully delivered in 66 out of 67 patients (98.5 %). Fifty patients were cured by EID after a mean time of 57.5 days and an average of 3.14 endoscopic sessions. Two died for event not related to EID. Nine are still under treatment; five failure had been registered. Six patients developed late stenosis treated endoscopically. CONCLUSIONS: EID proved to be a valid, curative, and safe mini-invasive approach for treatment of leaks following SG. EID achieves complete drainage of perigastric collections and stimulates mucosal growth over the stent. EID is well tolerated, allows early re-alimentation, and it is burdened by fewer complications than others technique. Long-term follow-up confirms good outcomes with no motility or feeding alterations.

Introduction: Treatment of pancreato-biliary disorders after gastric bypass is challenging due to altered anatomy. Several techniques have been proposed to overcome this condition; however, none has emerged as the gold standard treatment. Furthermore, a decision-making algorithm evaluating when and why apply one technique over another is still lacking. Objectives: To describe a novel trans-gastric approach to allow endoscopic retrograde cholangiopancreatography (ERCP) in Roux-en-Y gastric bypass (RYGB) anatomy soon after prior laparoscopic cholecystectomy (LC) and to propose a decision-making algorithm for selection of the most suitable technique according a tailored approach. Setting: Private hospital. Methods: Between January and March 2020, patients with Roux-en-Y gastric bypass anatomy referred to our tertiary center to undergo ERCP after recent laparoscopic cholecystectomy were retrospectively evaluated. A 20 french (Fr) gastrostomy was performed during cholecystectomy. A single-stage ERCP was carried out by means of temporary trans-gastric stent deployment over a 20 Fr gastrostomy. Results: A total of 5 patients (mean age 41; mean body mass index 48.3) were enrolled. ERCP was performed after an average of 2 days from surgery. Technical and clinical success was achieved in 100%. No adverse events occurred. Spontaneous closure of the gastrostomy after its bedside removal was observed in all cases. Conclusions: Our approach allows to perform a single-stage ERCP in RYGB patients, early after LC, with no need of any other re-interventions. Any surgeon facing unexpected biliary disorders, during LC, can easily perform a 20 Fr gastrostomy thus allowing the patient to undergo early ERCP without any delay.

Background Endoscopy plays a pivotal role in the management of adverse events (AE) following bariatric surgery. Leaks, fistulae, and post-operative collection after sleeve gastrectomy (SG) may occur in up to 10% of cases. Objectives To evaluate the efficacy and safety of endoscopic internal drainage (EID) for the management of leak, fistula, and collection following SG. Setting Retrospective, observational, single center study on patients referred from several bariatric surgery departments to an endoscopic referral center. Methods EID was used as first-line treatment for the management of leaks, fistulae, and collections. Leaks and fistulae were treated with double pigtail stent (DPS) deployment in order to guarantee internal drainage and second intention cavity obliteration. Collections were treated with endoscropic ultrasound (EUS)–guided deployment of DPS or lumen apposing metal stents. Results A total of 617 patients (83.3% female; mean age, 43.1 yr) were enrolled in the study for leak (n = 300, 48.6%), fistula (n = 285, 46.2%), and collection (n = 32, 5.2%). Median follow-up was 19.5 months. Overall clinical success was 84.7% whereas 15.3% of cases required revisional surgery after EID failure. Clinical success according to type of AE was 89.5%, 78.5%, and 90% for leak, fistula, and collection, respectively. A total of 10 of 547 (1.8%) presented a recurrence during follow-up. A total of 28 (4.5%) AE related to the endoscopic treatment occurred. At univariate logistic regression predictors of failure were: fistula (OR 2.012), combined endoscopic approach (OR 2.319), need for emergency surgery (OR 1.755), and previous endoscopic treatment (OR 4.818). Conclusion Early EID for the management of leak, fistula, and post-operative collection after SG seems a safe and effective first-line approach with good long-term results.

Background: Post-operative collections are a recognized source of morbidity after abdominal surgery. Percutaneous drainage is currently considered the standard treatment but not all collections are accessible using this method. Since the adoption of EUS, endoscopic transmural drainage has become an attractive option in the management of such complications. The present study aimed to assess the efficacy, safety and modalities of endoscopic transmural drainage in the treatment of post-operative collections. Methods: Data of all patients referred to our dedicated multidisciplinary facility from 2014 to 2017 for endoscopic drainage of symptomatic post-operative collections after failure of percutaneous drainage or when it was deemed impossible, were retrospectively analyzed. Results: Thirty-two patients (17 males and 15 females) with a median age of 53 years old (range 31-74) were included. Collections resulted from pancreatic (n = 10), colorectal (n = 6), bariatric (n = 5), and other type of surgery (n = 11). Collection size was less than 5 cm in diameter in 10 (31%), between 5 and 10 cm in 17 (53%) ,and more than 10 cm in 5 (16%) patients. The median time from surgery to endoscopic drainage was 38 days (range 6-360). Eight (25%) patients underwent endoscopic guided drainage whereas 24 (75%) patients underwent EUS-guided drainage. Technical success was 100% and clinical success was achieved in 30 (93.4%) after a mean follow-up of 13.5 months (1.2-24.8). Overall complication was 12.5% including four patients who bled following trans-gastric drainage treated with conservative therapy. Conclusions: The present series suggests that endoscopic transmural drainage represents an interesting alternative in the treatment of post-operative collection when percutaneous drainage is not possible or fails.

Background A large number of patients who undergo laparoscopic sleeve gastrectomy present with surgical complications. Stenosis, in particular, occurs in .7%–4% of cases. Objectives To report our experience, results, and long-term follow-up after pneumatic dilation of late functional helix stenosis after laparoscopic sleeve gastrectomy. Setting Multicenter study led by an endoscopic tertiary referral center. Methods Thirty-five patients were dilated initially at 30 mm. Thirteen out of 35 patients underwent a second dilation up to 35 mm. Only 8 patients underwent a third pneumatic dilation up to 40 mm. The stricture was localized in the mid-body of the sleeve in 32 patients overall; 3 had narrowing adjacent to the cardia. Eleven twists formed an acute angle between the 2 segments of the stomach, whereas 24 angles were obtuse. Seven out of 35 patients presented with persistent dilated pouch above the twist. Two patients were lost to follow-up. Overall outcome at an average follow-up of 15.5 months after primary surgery (range 7–49 mo) was as follows: 12 clinical failures and 1 technical failure (40%) and 60% (20 out of 33) clinical success. Conclusion Pneumatic dilation of late functional helix stricture is an effective technique for treatment of dysphagia in the majority of patients treated. Complete helix stricture, defined in function of the angle within twist, as well as the presence of a persistently dilated gastric pouch above the kinking, seems to be correlated with higher failure rates.

Background: The Over-The-Scope Clip (OTSC®, Ovesco Endoscopy GmbH, Tübingen, Germany) is an innovative clipping device that provides a strong tissue grasp and compression without provoking ischemia or laceration. In this retrospective study we evaluated immediate and long-term success rates of OTSC deployment in various pathologies of the gastrointestinal (GI) tract. Methods: A total of 45 patients (35 female, 10 male) with an average age of 56 years old (range, 24–90 years) were treated with an OTSC for GI defects resulting from a diagnostic or interventional endoscopic procedure (acute setting group) or for fistula following abdominal surgery (chronic setting group). All procedures were performed with CO2 insufflation. Results: From January 2012 to December 2015 a total of 51 OTSCs were delivered in 45 patients for different kinds of GI defects. Technical success was always achieved in the acute setting group with an excellent clip adherence and a clinical long-term success rate of 100% (15/15). Meanwhile, considering the chronic setting group, technical success was achieved in 50% of patients with a long-term clinical success of 37% (11/30); two minor complications occurred. A total of three patients died due to causes not directly related to clip deployment. Overall clinical success rate was achieved in 58% cases (26/45 patients). A mean follow-up period of 17 months was accomplished (range, 1–36 months). Conclusion: OTSC deployment is an effective and minimally-invasive procedure for GI defects in acute settings. It avoids emergency surgical repair and it allows, in most cases, completion of the primary endoscopic procedure. OTSC should be incorporated as an essential technique of today’s modern endoscopic armamentarium in the management of GI defects in acute settings. OTSCs were less effective in cases of chronic defects.

Background and study aims Revision of endoscopic retrograde cholangiopancreatography (ERCP) may be necessary following previous biliary endoscopic sphincterotomy for recurrent biliary symptoms related to biliary stone recurrence, cholangitis or post-biliary endoscopic sphincterotomy (bEST) papillary stenosis and cholestasis. The aim of this retrospective study was to evaluate the clinical outcome and complication rate associated with re-cut, balloon dilation and biliary metal stenting in revision ERCP. Patients and methods From January 2010 to January 2015, 139 subjects with stigma of a previous sphincterotomy required a revision ERCP (64 Men/75 Women; mean age 71 years; range 32 – 101 years). The most appropriate technique (re-cut, balloon dilation or fully covered self-expandable metal stent [FCSEMS] placement) was tailored according to underlying pathologies and anatomical features. Results Technical success was achieved in all cases (100 %).Clinical success (definitive clearance of common bile duct stones and liver test normalization) was achieved in 127 out of 139 patients (91.4 %) with a mean follow up of 12 months.12 clinical failures occurred: 11 patients required a new ERCP after an average of 9 months meanwhile 1 patient required surgery for definite treatment. The overall complication rate was 9 % (13 /139) with 5 acute complications (intra-procedural) and 8 short-term complications (before 1 month). Group specific overall complication rates were as follow: re-cut 11.5 % (8 bleeds and 3 perforations), balloon dilation 25 % (4 mild PEP [post-ERCP pancreatitis]), FCSEMS 14.3 % (1 moderate PEP), re-cut + balloon dilation and re-cut + FCSEMS 0 %. A statistically significant higher risk of post-ERCP pancreatitis was highlighted in the balloon dilation group meanwhile re-cut was burdened by a higher risk of bleeding and perforation. Conclusions Revision ERCP following previous bEST is a feasible procedure enabling clinical success in most cases. Different approaches are available and must be considered according to underlying pathologies. Re-cut is burdened by a higher risk of perforation and bleeding compared to balloon dilation and SEMS meanwhile balloon dilation is associated to increased risk of PEP.

We welcomed with great interest the masterpiece of Nedelcu et al. [1] concerning the outcome of leaks after laparoscopic sleeve gastrectomy (LSG) based on a new algorithm addressing leak size and gastric stenosis. The article stressed the importance of adopting this new algorithm in order to standardize leak management, thus reducing the number of endoscopic procedures. We agree with the authors about the use of endoscopic internal drainage (EID) by means of double pigtail to achieve complete healing. As already reported by our team [2], since March 2013, we adopted EID as the only endoscopic treatment in case of fistulas after LSG or gastric bypass, irrespective to leak size. Moreover, we believe in the importance of introducing a well-defined algorithm in order to standardize the endoscopic treatment modality for leak following bariatric surgery. However, according to our experience, we have some remarks to do. Here, we report a case of a 59-year-old woman, presenting an early fistula [3] following laparoscopic sleeve gastrectomy. At day 12 after surgery, she underwent reoperation for peritonitis with lavage and drainage of peritoneal cavity, and two peri-gastric surgical drainage were left in place. No primary repair was attempted due to severe local tissue inflammation. Endoscopy showed a 2-cm-long dehiscence, of the last staple fire line, allowing passing through with the scope. Swallow study through the scope showed the persistence of intra-abdominal collection in the left hypochondrium and the presence of a left bronchial tree fistula (Fig. 1). EID was performed and two 10 Fr double pigtail drains (DPD) were positioned with the aim to drain and promote re-epithelialization of the cavity. After four endoscopic sessions, an Ovesco® clip (OTSC®; Ovesco Endoscopy GmbH, Tubingen, Germany) was delivered to close the remaining blind cross-fistula.

Background: Roux-en-Y gastric bypass (RYGB) is complicated by a leak in 0-4.3% of cases. Treatment by fully covered stents has been reported to be associated with some life-threatening complications. We report our experience of insertion of double pigtail stents. Methods: Thirty-three patients (20M, 43 years-20/65), presenting with a leak at an average of 10 days after RYGB (4-35), were treated by double pigtail stent insertion and a nasojejunal feeding tube. Sixty percent of these patients had undergone surgical drainage prior to stenting for control of sepsis. Thirty leaks were located at the top of staple line and three at the gastro-jejunal anastomosis. At a 4-weekly follow-up, ablation or re-stenting was performed depending on status of fistula closure and patients were placed on normal diet. Results: At the first follow-up, 10/33 fistulae healed, one patient presented with clinical failure (3%) and needed surgery, and 22/33were re-stented. Twenty-one out of these 22 developed a secondary sub-clinical gastro-gastric fistula and one, instead, developed complex (gastro-gastric, gastro-colic) fistula. All (22) primary fistulae healed following four more weeks of treatment. Average treatment duration was of 61 days (28-99). Thirty-two patients (97%) at a follow-up of 1-33 months are asymptomatic. Conclusions: Leaks following RYGB can be successfully and safely managed by double pigtail stents. Upper gastric staple line leaks are responsible for the formation of a secondary sub-clinic gastro-gastric fistula which needs no additional treatment.

Successful management of endoscopic retrograde cholangiopancreatography (ERCP)-related duodenal perforations, up to 20 mm, has been reported using several endoscopic devices [Von Renteln et al. 2010; Buffoli et al. 2012; Dogan et al. 2013; Donatelli et al. 2013; Meduri et al. 2014], however, surgery remains the standard of care management of larger defects [Wu et al. 2006; Lee et al. 2013]. Here we report, to the best of the authors’ knowledge, the first case of successful treatment of a large duodenal perforation (>20 mm) during ERCP, using several Ovesco clips. A 66-year-old white man was addressed for biliary drainage due to important cholestasis secondary to a liver metastatic lesion of an urothelial cancer treated by surgery and chemotherapy. During ERCP and while delivering the third plastic 10F stent (Figure 1) a movement of the endoscope provoked a large retroperitoneal duodenal perforation occupying 1/3 of the duodenal wall (Figure 2), opposite to the papilla at the early beginning of second duodenum. The size of perforation was important, mostly because the duodenal wall is thin and injury provoked a mucosal laceration with tearing of the wall. The decision to deliver a plastic stent instead of a metal one was taken given the poor prognosis of the patient, and namely because the stenosis was evaluated as ‘Bismuth IV’, and in the case of no improvement of liver function tests, a radiological percutaneous transhepatic approach would be compromised. Then the duodenoscope together with the partially delivered stent were immediately retrieved. A standard gastroscope loaded with an 11t Ovesco (OTSC®; Ovesco Endoscopy GmbH, Tubingen, Germany), under CO2 insufflation, was introduced but unfortunately the duodenal tear was too large, both in length and width, making it impossible to aspirate both edges of the tear in the cap or approach using a Twin Grasper®. A coloscope loaded with a 14t Ovesco was subsequently introduced and endoscopic suturing was started between the greater omentum and one edge of the duodenal tear (Figure 3). Since a closure defect persisted at the other end as shown after contrast-medium injection (Figure 4), the gastric Ovesco was delivered while aspirating the omentum incarcerated between the first colic clip and the free edge of the perforation, achieving full closure without contrast-medium extravasation (Figure 5). A nasogastric tube was left in place in soft aspiration. The patient was then transferred to the intensive care unit (ICU), for surveillance, where he remained for 7 days before being discharged. During his stay in the ICU, no fever was detected, the liver function tests were improved, and no further ERCP was needed to add the third stent. We only noticed a transient rise of the C-reactive protein, before its complete normalization, and CT scan as well as water-soluble contrast upper-studies performed on days 2 and 5 postoperatively were normal (Figure 6). Oral nutrition was started on day 6. At 1 month after endoscopy, the patient is fully asymptomatic. Figure 1. Hilar stenosis with 2 plastic stents in place. The guidewire in the left duct is about be placed, in order to deliver the third stent. Figure 2. Large duodenal defect. Figure 3. Colic clip Ovesco in place incarcerating greater omentum. Figure 4. Contrast-medium extravasation at the one end of the duodenal perforation despite colic Ovesco placement, given the large size of the defect. Figure 5. Watertight closure achieved using a ‘bridge technique’ using Ovesco on Ovesco. Figure 6. CT scan showing clips in place with no extravasation of contrast medium. In conclusion OTSC is a surgery-sparing device, and colic and gastric clips together can be a useful tool for the closure of large duodenal defects. However, the use of a colic Ovesco should be considered too, mainly because of its size, for upper gastrointestinal interventions in an expert’s hands.

Over-the-scope clip closure of iatrogenic gastrointestinal tract perforations has been successfully demonstrated, and is usually performed in the immediate peroperative setting [1,2]. We report the first case, to our knowledge, of delayed successful treatment of an iatrogenic colon perforation using an over-the-scope clip. An 80-year-old woman underwent routine colonoscopy. Her medical history was unremarkable apart from unexplained thrombocytopenia (40000 platelets/dL). During endoscopy, a perforation occurred at the level of the sigmoid junction with the left colon (●" Fig.1). At that time, after multidisciplinary discussion, and in view of the successful colonic preparation and the thrombocytopenia, a mini-invasive endoscopic treatment was proposed (the patient being on antibiotics). Two and a half hours later the patient was transferred to our unit for an attempt at clip closure. Using a gastroscope and CO2 insufflation, a 7-mm perforation orifice was visualized. An OTSC 11/6t clip (Ovesco Endoscopy GmbH, Tubingen, Germany) was then delivered, with aspiration of the edges of the orifice (●" Fig.2, ●" Fig.3). Contrast medium study through the endoscope performed at that time did not show any fluid extravasation (●" Fig.4). The day after the procedure, the patient presented localized peritoneal irritation and fever (38°C). Lab tests showed no hyperleukocytosis, but the C-reactive protein level had increased to 204U/L. Spiral CT with bowel opacification performed then confirmed a sealed clip closure with no free fluid or air in the peritoneal cavity (●" Fig.5). The patient was kept fasting until bowel transit was re-established 2 days later. She was symptom-free by the Fig.4 Watertight closure with no extravasation of contrast medium.