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Background: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),β but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS. Methods: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. ClinicalTrials.gov, NCT03100578. Results: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88–2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92–1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, − 10 [95% CI − 17.5, − 1]; p = 0.077) and global hospitalization (median difference − 4 [95% CI − 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08–0.83], p = 0.015). Conclusions: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed. Trial registration number: ClinicalTrials.gov, NCT03100578. [ABSTRACT FROM AUTHOR]

Introduction: Migration of fully covered metal stents (FCMS) remains a limitation of the endoscopic treatment of anastomotic biliary strictures (ABS) following orthotopic liver transplantation (OLT). The use of antimigration FCMS (A-FCMS) might enhance endoscopic treatment outcomes for ABS. Methods: Single center retrospective study. Consecutive patients with ABS following OLT who underwent ERCP with FCMS placement between January 2005 and December 2020 were eligible. Subjects were grouped into conventional-FCMS (C-FCMS) and A-FCMS. The primary outcome was stent migration rates. Secondary outcomes were stricture resolution, adverse event, and recurrence rates. Results: A total of 102 (40 C-FCMS; 62 A-FCMS) patients were included. Stent migration was identified at the first revision in 24 C-FCMS patients (63.2%) and in 21 A-FCMS patients (36.2%) (p = 0.01). The overall migration rate, including the first and subsequent endoscopic revisions, was 65.8% in C-FCMS and 37.3% in A-FCMS (p = 0.006). The stricture resolution rate at the first endoscopic revision was similar in both groups (60.0 vs 61.3%, p = 0.87). Final stricture resolution was achieved in 95 patients (93.1%), with no difference across groups (92.5 vs 93.5%; p = 0.84). Adverse events were identified in 13 patients (12.1%) with no difference across groups. At a median follow-up of 52 (IQR: 19–85.5) months after stricture resolution, 25 patients (24.5%) developed recurrences, with no difference across groups (C-FCMS 30% vs A-FCMS 21%; p = 0.28). Conclusions: The use of A-FCMS during ERCP for ABS following OLT results in significantly lower stent migration rates compared to C-FCMS. However, the clinical benefit of reduced stent migration is unclear. Larger studies focusing on stricture resolution and recurrence rates are needed [ABSTRACT FROM AUTHOR]

Background: It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction. Methods/design: This is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate). Discussion: The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction. Trial registration: ClinicalTrials.govNCT04595058. Registered on October 14, 2020. [ABSTRACT FROM AUTHOR]

Background and aims: EUS-guided choledochoduodenostomy (EUS-CDS) is an effective option for biliary drainage in malignant biliary obstruction. Lumen apposing metal stents (LAMS) are increasingly been used for EUS-CDS. It is unknown how LAMS compare to tubular self-expandable metal stents (SEMS) for EUS-CDS. Our aim is to compare the clinical outcomes of LAMS versus SEMS for EUS-CDS. Patients and methods: Single-center retrospective cohort study of consecutive patients with unresectable malignant biliary obstruction who underwent EUS-CDS after failed ERCP for initial biliary drainage between 2011 and 2019. Clinical outcomes were compared between patients who had conventional covered SEMS and LAMS placed for EUS-CDS. Outcome measures included unplanned procedural events, technical success, clinical success, adverse events and reinterventions. Survival was analyzed by the Kaplan–Meier method. Results: During the study period 57 patients met inclusion criteria (37 LAMS, 20 SEMS). All EUS-CDS were technically successful (LAMS group 95% CI 90.3–100%, SEMS group 95% CI 83.2–100%). There were no differences between groups in unplanned procedural events (4 LAMS deployment issues, 2 mild bleeding in SEMS group; 10 vs 10.8%), clinical success (37/37 [100%] vs 19/20 [95%]), and short-term adverse events (5/37 [13.5%] vs 4/20 [20%], p = 0.71). Complete follow-up data were available in 41 patients for a mean of 376 ± 145 days. Endoscopic reintervention was required for duodenal stent placement (n = 9) or biliary stent dysfunction (n = 4), with no difference between LAMS and SEMS group (6/37 [16.2%] vs 7/20 [35%]). There were no differences in overall survival between both groups. Conclusions: EUS-guided choledochoduodenostomy after failed ERCP has equally high technical and clinical success rates with either LAMS or SEMS in patients with malignant biliary obstruction. No differences in adverse events, reinterventions and survival were seen with either type of stent. The cost-effectiveness of LAMS vs SEMS for EUS-guided choledochoduodenostomy remains to be proven. [ABSTRACT FROM AUTHOR]

EUS-cholangiography revealed a dilated common bile duct (CBD) and a patent cystic duct above a distal stricture (Fig. In malignant biliary obstruction, EUS-guided gallbladder drainage allows symptomatic decompression when the cystic duct is involved [3] and rescue biliary drainage when it is patent [4]. [Extracted from the article]

Background: It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven.Methods/design: This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences.Discussion: The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.Trial Registration: ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home. [ABSTRACT FROM AUTHOR]

Background: Delayed gastrointestinal (GI) bleeding and stent migration are known adverse events which may occur following placement of lumen-apposing metal stents (LAMSs).Methods: All consecutive patients who underwent LAMS placement between May 2011 and June 2017 at a single tertiary medical center were included. Demographics and procedural details were prospectively collected. Post-procedure follow-up and outcome measures were retrospectively collected. The cumulative risks of migration and LAMS-related GI bleeding were estimated using the life-table method. Risk predictors were assessed using Cox proportional hazards models.Results: We analyzed 250 patients (64.8 % men; median age 71.6 [interquartile range (IQR) 57.9 - 83.6]). Median follow-up was 78.5 days (IQR 31 - 246.5 days). Thirty-four stent migrations (13.6 %) occurred (5 symptomatic). On multivariable analysis, associations with migration included nasocystic drains (hazard ratio [HR] 6.5, 95 % confidence interval [CI] 2.2 - 19.3), pancreatic fluid collections (PFCs; HR 4.2, 95 %CI 1.8 - 10.1), and double-pigtail stents (HR 2.4, 95 %CI 1.2 - 4.9). Migration risk at 12 months was 25.5 % (95 %CI 17.9 % - 35.7 %) and was higher for PFCs 48.9 % (33.4 % - 66.9 %) than other indications 8.4 % (4.9 % - 17.5 %; P < 0.001). LAMSs placed for longer durations (i. e. enteral anastomoses, biliary and gallbladder drainage) presented an 8.4 % cumulative risk at 2 years. There were 13 LAMS-related GI hemorrhages (5.2 %), two of them fatal, presenting a median of 3 days (IQR 1 - 9 days) after deployment. The cumulative risk of bleeding at 12 months was 6.9 % (3.6 % - 12.7 %).Conclusions: LAMS migration occurs in 1 out of 7 cases and is most common when treating PFCs. Bleeding related to LAMS placement occurs much less commonly but can be life-threatening. [ABSTRACT FROM AUTHOR]

Correction to: Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction - BAMPI TRIAL: an open-label, randomized controlled trial protocol Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction - BAMPI TRIAL: an open-label, randomized controlled trial protocol. B Correction to: Trials 23, 181 (2022) b B https://doi.org/10.1186/s13063-022-06106-1 b Following the publication of the original article [[1]], we were notified that the below statement needed to be added to the Acknowledgements section:'We thank CERCA Programme / Generalitat de Catalunya for institutional support'. [Extracted from the article]