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Abstract Background and aims There are different therapeutic approaches for biliary strictures and reducing portal hypertension in patients with symptomatic portal cavernoma cholangiopathy (PCC). Endoscopic treatment includes endoscopic biliary sphincterotomy (EST), dilation of stricture with a biliary balloon, placement of plastic stent(s) and stone extraction. Fully covered self-expandable metal stent (FCSEMS) is placed as a rescuer in case of haemobilia seen after EST, dilation of stricture and removal of plastic stent rather than the stricture treatment itself. In this retrospective observational study, we sought to assess the clinical outcomes of FCSEMS as the initial treatment for PCC-related biliary strictures. Materials and methods Twelve symptomatic patients with PCC both clinically and radiologically between July 2009 and February 2019 were examined. Magnetic resonance cholangiopancreatography (MRCP) and cholangiography were employed as the diagnostic imaging methods. Chandra–Sarin classification was used to distinguish between biliary abnormalities in terms of localization. Llop classification was used to group biliary abnormalities associated with PCC. Endoscopic partial sphincterotomy was performed in all the patients. If patients with dominant strictures 6-8-mm balloon dilation was first performed. This was followed by removal of the stones if exist. Finally, FCSEMS placed. The stents were removed 6–12 weeks later. Results The mean age of the patients was 40.9 ± 10.3 years, and 91.6% of the patients were male. Majority of the patients (n = 9) were noncirrhotic. Endoscopic retrograde cholangiopancreatography (ERCP) findings showed that 11 of the 12 patients were Chandra Type I and one was Chandra Type IIIa. All the 12 patients were Llop Grade 3. All patients had biliary involvement in the form of strictures. Stent placement was successful in all patients. FCSEMSs were retained for a median period of 45 days (30–60). Seven (58.3%) patients developed acute cholecystitis. There was no occurrence of bleeding or other complications associated with FCSEMS replacement or removal. All patients were asymptomatic during median 3 years (1–10) follow up period. Conclusions FCSEMS placement is an effective method in biliary strictures in case of PCC. Acute cholecystitis is encountered frequently after FCSEMS, but majority of patients respond to the medical treatment. Patients should be followed in terms of the relapse of biliary strictures.

Background and aims: There are different therapeutic approaches for biliary strictures and reducing portal hypertension in patients with symptomatic portal cavernoma cholangiopathy (PCC). Endoscopic treatment includes endoscopic biliary sphincterotomy (EST), dilation of stricture with a biliary balloon, placement of plastic stent(s) and stone extraction. Fully covered self-expandable metal stent (FCSEMS) is placed as a rescuer in case of haemobilia seen after EST, dilation of stricture and removal of plastic stent rather than the stricture treatment itself. In this retrospective observational study, we sought to assess the clinical outcomes of FCSEMS as the initial treatment for PCC-related biliary strictures. Materials and methods: Twelve symptomatic patients with PCC both clinically and radiologically between July 2009 and February 2019 were examined. Magnetic resonance cholangiopancreatography (MRCP) and cholangiography were employed as the diagnostic imaging methods. Chandra–Sarin classification was used to distinguish between biliary abnormalities in terms of localization. Llop classification was used to group biliary abnormalities associated with PCC. Endoscopic partial sphincterotomy was performed in all the patients. If patients with dominant strictures 6-8-mm balloon dilation was first performed. This was followed by removal of the stones if exist. Finally, FCSEMS placed. The stents were removed 6–12 weeks later. Results: The mean age of the patients was 40.9 ± 10.3 years, and 91.6% of the patients were male. Majority of the patients (n = 9) were noncirrhotic. Endoscopic retrograde cholangiopancreatography (ERCP) findings showed that 11 of the 12 patients were Chandra Type I and one was Chandra Type IIIa. All the 12 patients were Llop Grade 3. All patients had biliary involvement in the form of strictures. Stent placement was successful in all patients. FCSEMSs were retained for a median period of 45 days (30–60). Seven (58.3%) patients developed acute cholecystitis. There was no occurrence of bleeding or other complications associated with FCSEMS replacement or removal. All patients were asymptomatic during median 3 years (1–10) follow up period. Conclusions: FCSEMS placement is an effective method in biliary strictures in case of PCC. Acute cholecystitis is encountered frequently after FCSEMS, but majority of patients respond to the medical treatment. Patients should be followed in terms of the relapse of biliary strictures. [ABSTRACT FROM AUTHOR]

Background and aims: In the treatment of post-cholecystectomy bile leaks, endoscopic naso-biliary drainage (ENBD) or biliary stenting using plastic stents is the standard of care. Fully covered self-expandable metal stent (FCSEMS) placement across the sphincter of Oddi is considered a salvage therapy for refractory cases, but pancreatitis and migration are the major concerns. Intraductal placement of a dumbbell-shaped FCSEMS (D-SEMS) could avoid these drawbacks of FCMSESs. In this retrospective study, we investigated the usefulness of intraductal placement of the D-SEMS for post-cholecystectomy bile leaks. Methods: Six patients who underwent intraductal placement of the D-SEMS for post-cholecystectomy bile leaks were enrolled. This method was performed as initial treatment in three patients and as salvage treatment in three ENBD refractory cases. Results: Technical and clinical successes were obtained in 6 (100%) patients and 5 (83%) patients, respectively. One clinically unsuccessful patient required laparoscopic peritoneal lavage. The early adverse event was one case of mild pancreatitis (17%). The median duration of the D-SEMS indwelling was 61 days (42–606 days) with no migration cases, all of which were successfully removed. The median follow-up after index ERCP was 761 (range: 161–1392) days with no cases of recurrent bile leaks. Conclusions: Intraductal placement of the D-SEMS for post-cholecystectomy bile leaks might be safe and effective even in refractory cases. [ABSTRACT FROM AUTHOR]

Background: Over-the-scope clips (OTSC), both conventional and Stentfix, are believed to anchor the self-expanding metal (SEMS) and prevent migration. We aimed to systematically study the efficacy of endoscopic OTSC fixation of SEMS in prevention of migration. Methods: We searched electronic databases from inception to November 11, 2022 to identify studies reporting outcomes of OTSC fixation of metal stents. The primary outcome was to calculate the pooled migration rates following OTSC anchorage of SEMS and to compare it with controls (SEMS without any fixation). The secondary outcomes include technical and clinical success of OTSC anchorage of SEMS. Random effect models were used to determine pooled rates of migration and technical as well as clinical success rates of OTSC anchorage of metal stents. Results: A total of 9 studies were included. The pooled rate of migration following OTSC anchorage of SEMS was 0.10 (95%CI, 0.04–0.20, I2 = 43%). The pooled rate of migration following OTSC anchorage of esophageal SEMS was 0.08 (95%CI, 0.04–0.15, I2 = 0%). The pooled risk ratio of SEMS migration following OTSC Stentfix was lower as compared to no fixation of SEMS [RR = 0.24 (95%CI,0.13- 0.43, I2 = 0)]. The pooled technical success rate of OTSC fixation following SEMS was 0.98 (95%CI, 0.81–1.00, I2 = 0%). The pooled clinical success rate of OTSC fixation following SEMS was 0.79 (95%CI, 0.64–0.88, I2 = 56%). All studies had valid and reliable methods to diagnose migration, technical and clinical success. Conclusions: The use of OTSC clips (conventional or Stentfix) for anchorage had a lower risk of migration of metal stents than no fixation. Future studies should look into prospective multicenter studies on their use to prevent the migration of SEMS. [ABSTRACT FROM AUTHOR]

Abstract Background We report our experience of treating anastomotic strictures using a novel type of fully covered metal stent (FCSEMS). This stent, known as the Kaffes Stent, is short-length with an antimigration waist and is easily removable due to long retrieval wires deployed within the duodenum. Methods Sixty-two patients underwent ERCP and Kaffes stent insertion for post-transplant anastomotic strictures following confirmation of a stricture on MRCP. These patients were retrospectively analysed for immediate and long-term stricture resolution, improvement in symptoms and liver function tests (LFTs), stricture recurrence and complication rates. Results Of the 56 patients who had their stent removed at the time of analysis, 54 (96%) had immediate stricture resolution and 42 continued to have long-term resolution (mean follow-up period was 548 days). Of the 16 patients with symptoms of biliary obstruction, 13 had resolution of their symptoms. Overall, there was a significant improvement in LFTs after stent removal compared to before stent insertion. Complication rates were 15% with only one patient requiring biliary reconstruction. Conclusions The Kaffes stent is effective and safe at resolving post liver transplant biliary anastomotic strictures.

Background: Endoscopic ultrasound (EUS)-guided drainage of pancreatic wall-off necrosis (WON) with transmural stent is regarded as firstline therapy. We aimed at comparing its efficacy and safety with using fully covered self-expandable metal stent (FCSEMS) and lumen-apposing metal stent (LAMS).Methods: A retrospective review was performed on all consecutive patients with pancreatic WONs who underwent EUS-guided drainage by either FCSEMS or LAMS.Results: From 2011 to 2016, 68 patients (66.2% male, median age, 66.5 years) underwent WON drainage (22/68 (32.4%) using FCSEMSs of size 10 × 60 mm (14/22, Hanarostent; 8/22 Wallflex); 46/68 (67.6%) using LAMSs (38/46 and 8/46 with AXIOS of size 15 × 10 mm and 10 × 10 mm, respectively). These two groups were matched for age (66 vs. 70 years, p 0.514), APACHE II (11.5 vs. 10, p 0.693), causes [72.7 vs. 80.4% by gallstone pancreatitis (p 0.472); 9.1 vs. 10.9% by alcoholism (p 0.818)], WON size (8.5 vs. 9 cm, p 0.322), location (36.4 vs. 26.1% at pancreatic head, p 0.384; 54.5 vs. 65.2% at body/tail, p 0.395), and enterostomy site [63.6 vs. 76.1% via transgastric (p 0.285); 31.8 vs. 19.6% via transduodenal (p 0.267)] and their number of necrosectomy (p 0.978). The technical (100 vs. 93.5%, p 0.219) and clinical (95.5 vs. 93.5%, p 0.749) success and adverse event (22.7 vs. 39.1%, p 0.180; 9.1 vs. 19.6% with bleeding, p 0.271; 4.5 vs. 13% with spontaneous stent migration, p 0.28; 9.1 vs. 6.5% with dislodgement during necrosectomy, p 0.704) of the two groups were comparable without significant different. However, the LAMS group associated with early stent revision compared with FCSEMS group (log rank p 0.048).Conclusions: EUS-guided drainage of WON using FCSEMSs and LAMSs are comparable in efficacy and safety; however, the latter is associated with early stent revision. [ABSTRACT FROM AUTHOR]

Background: Endotherapy with plastic stent (PS) placement is the main modality for treating benign biliary strictures (BBSs). Fully covered self-expandable metal stents (FCSEMSs) are being increasingly used for BBS management, with high stricture resolution. However, traditional metal tents are associated with high migration, causing treatment failure.Methods: We investigated the efficacy and safety of a new FCSEMS for postsurgical BBS treatment and compared these parameters between the FCSEMS and PS treatment through retrospective analysis. The primary outcome measurements included stricture resolution, stricture recurrence, and complications.Results: In total, 69 patients were included, of whom 32 underwent FCSEMS treatment and 37 underwent PS treatment. The technical success rate and the number of endoscopic retrograde cholangiopancreatography procedures were similar between the groups. The median stenting duration was 5.2 months (range 1.5-15.3) in the FCSEMS group and 10.7 months (range 2.5-22.6) in the PS group (P < 0.01). The stents removal rate was 96.9% in the FCSEMS group and 94.6% in the PS group. The stricture resolution rate based on intention-to-treat analysis was 83.8% in the PS group and 84.4% (27/32) in the FCSEMS group (P = 0.947), whereas the rates from per-protocol analysis were 88.6% (31/35) and 87.1% (27/31), respectively (P = 0.574). Early and late complications were similar between the groups. The median follow-up time was 43 months (range 13-71). The stricture recurrence rate was 11.1% (3/27) in the FCSEMS group and 16.1% (5/31) in the PS group (P = 0.435).Conclusions: The new FCSEMS and the PS approach showed similar efficacy and safety in postsurgical BBS treatment. However, the FCSEMS required fewer procedural steps and shorter stenting time, making it an effective alternative modality. [ABSTRACT FROM AUTHOR]

Background: Temporary placement of removable, fully covered, self-expandable metal stents (fcSEMS) for treatment of benign biliary strictures (BBS) has been reported to be effective. However, the optimal extraction time point remains unclear and stent migration has been a major concern., Objective: The objective of this study was to evaluate the efficacy and safety of this treatment modality using an fcSEMS with a special antimigration design and prolonged stent indwell time., Methods: We performed a prospective, single-arm study at six tertiary care centers in Europe. Patients with BBS underwent endoscopic or percutaneous implantation of an fcSEMS (GORE® VIABIL® Biliary Endoprosthesis, W.L. Gore & Associates, Flagstaff, AZ, USA). The devices were scheduled to be removed nine months later, and patients were to return for follow-up for an additional 15 months., Results: Forty-three patients were enrolled in the study. Stricture etiology was chronic pancreatitis in the majority of patients (57.5%). All fcSEMS were placed successfully, either endoscopically (76.7%) or percutaneously (23.3%). Stent migration was observed in two patients (5.2%). Primary patency of the SEMS prior to removal was 73.0%. All attempted stent removals were successful. At removal, stricture was resolved or significantly improved without need for further therapy in 78.9% of patients. Stricture recurrence during a follow-up of two years post-implant was observed in two patients., Conclusions: Temporary placement of the fcSEMS is a feasible, safe and effective treatment for BBS. The design of the device used in this study accounts for very low migration rates and facilitates easy stent retrieval, even after it has been in place for up to 11 months.

Background: Endoscopic treatment of benign biliary strictures (BBS) can be challenging., Objective: To evaluate the efficacy of fully covered self-expandable metal stents (FCSEMS) in BBS., Methods: Ninety-two consecutive patients with BBS (chronic pancreatitis (n = 42), anastomotic after liver transplantation (n = 36), and post biliary surgical procedure (n = 14)) were included. FCSEMS were placed across strictures for 6 months before endoscopic extraction. Early success rate was defined as the absence of biliary stricture or as a minimal residual anomaly on post-stent removal endoscopic retrograde cholangiopancreatography (ERCP). Secondary outcomes were the final success and stricture recurrence rates as well as procedure-related morbidity., Results: Stenting was successful in all patients. Stenting associated complications were minor and occurred in 22 (23.9%) patients. Migration occurred in 23 (25%) patients. Stent extraction was successful in all but two patients with proximal stent migration. ERCP after the 6 months stenting showed an early success in 84.9% patients (chronic pancreatitis patients: 94.7%, liver transplant: 87.9%, post-surgical: 61.5%) (p = 0.01). Final success was observed in 57/73 (78.1%) patients with a median follow-up of 12 ± 3.56 months. Recurrence of biliary stricture occurred in 16/73 (21.9%) patients., Conclusions: FCSEMS placement is efficient for patients with BBS, in particular for chronic pancreatitis patients. Stent extraction after 6 months indwelling, although generally feasible, may fail in a few cases.

Background and Aims: Refractory chronic pancreatitis has been proposed as a challenge for endoscopists following routine single plastic stenting. However, data on the efficacy and safety of further endoscopic stenting are still controversial. The current systematic review aimed to assess the efficacy and safety of placement of fully covered self-expandable metal stent (FCSEMS) and multiple plastic stents., Methods: Databases including MEDLINE, EMBASE, the Cochrane Library, CBM, CNKI, VIP, and WANFANG Database were used to search relevant trials. Published studies were assessed by using well-defined inclusion and exclusion criteria. The process was independently performed by two investigators., Results: A total of 5 studies provided data of 80 patients. Forest plots and publication bias were not carried out because few studies were relevant and screened studies were all case series. The technical success rate was 100% both in placement of FCSEMS and multiple plastic stents. The functional success rate after placement of FCSEMS was 100%, followed by multiple plastic stents (94.7%). Complications occurred 26.2% after FCSEMS placement, which was not described in detail in multiple plastic stents. The stent migration rate was 8.2% for FCSEMS and 10.5% for multiple plastic stents. Reintervention rate was 9.8% for FCSEMS and 15.8% for multiple plastic stents. Pain improvement rate was 85.2% for FCSEMS and 84.2% for multiple plastic stents., Conclusions: FCSEMS appeared to be no significant difference with multiple plastic stents in treatment of refractory chronic pancreatitis. We need to develop more investigations., (Copyright © 2014 IAP and EPC. Published by Elsevier B.V. All rights reserved.)

Background: Endotherapy of postcholecystectomy bile duct stricture (PCBS) has been established as an alternative treatment to surgery. Several studies have reported conflicting results regarding the predictors of success or failure of endotherapy., Objective: To evaluate the different cholangioscopic appearances of PCBS after endotherapy with an increasing number of plastic stents and the predictive values of these appearances for the outcome., Design: Prospective study with a long-term follow-up., Setting: Two academic tertiary referral centers., Patients: Twenty consecutive patients with major bile duct injury, with a bile leak, and a PCBS who underwent therapeutic ERCP., Interventions: Closure of the leak followed by temporary placement of multiple plastic stents for the treatment of PCBS, followed by cholangioscopy at the end of endotherapy., Main Outcome Measurements: To analyze the predictive value of cholangioscopy, other predictors of stricture recurrence after endotherapy, and long-term clinical success., Results: Closure of the leak was achieved in all patients. The median duration of endotherapy was 12 months (range 7-18 months). After endoscopic stenting, the PCBS was considered to be appropriately dilated in all patients. After endotherapy, 3 different findings were noted on cholangioscopy: (1) no lesion or minor defect (n = 10), (2) minor stricture with a fibrous ring (n = 6), and (3) presence of tissue hyperplasia (n = 4). During follow-up, stricture recurrence developed in 4 of 20 patients. All 4 patients were successfully retreated by an additional period of stenting and remained free of cholestasis after a median follow-up period of 44 months. By Kaplan-Meier (log-rank) and univariate analyses, the cholangioscopic pattern of tissue hyperplasia was significantly associated with stricture recurrence (P < .01)., Limitations: Small sample size., Conclusions: Endoscopic stenting should be regarded as the primary treatment of choice because of the successful long-term outcome after 1 or more additional periods of treatment. However, the cholangioscopic pattern of tissue hyperplasia at the time of stent removal is a strong predictor of stricture recurrence, and this observation may lead to an additional period of endotherapy or other treatment modalities., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)