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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.

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.