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Background and Aim: This study aimed to determine safety and risk factors for adverse events (AEs) of endoscopic ultrasound‐guided gallbladder drainage (EUS‐GBD) with long‐term indwell of lumen‐apposing metal stents (LAMS). Methods: This study is a multicenter prospective observational study on consecutive high surgical‐risk patients requiring gallbladder drainage who underwent EUS‐GBD with LAMS over 12 months. Centralized telephone follow‐up interviews were conducted every 3 months for 1 year. Patients were censored at LAMS removal, cholecystectomy, or death. AE‐free survival was determined using log–rank tests. Cumulative risks were estimated using life‐table analysis. Results: Eighty‐two patients were included (53.7% male, median [interquartile range] age of 84.6 [76.5–89.8] years, and 85.4% with acute cholecystitis). Technical success was achieved in 79 (96.3%), and clinical success in 73 (89%). No patient was lost to follow‐up; 45 patients (54.9%) completed 1‐year follow‐up with in situ LAMS. Median (interquartile range) LAMS indwell time was 364 (47–367) days. Overall, 12 (14.6%) patients presented 14 AEs, including 5 (6.1%) recurrent biliary events (3 acute cholangitis, 1 mild acute pancreatitis, and 1 acute cholecystitis). Patients with pancreatobiliary malignancy had an increased risk of recurrent biliary events (33% vs 1.5%, P = 0.001). The overall 1‐year cumulative risk of recurrent biliary events was 9.7% (4.1–21.8%). The 1‐year risk of AEs and of severe AEs was 18.8% (11–31.2%) and 7.9% (3.3–18.2%), respectively. Pancreatobiliary malignancy was the single risk factor for recurrent biliary events; LAMS misdeployment was the strongest risk factor for AEs. Conclusions: Long‐term LAMS indwell does not increase the risk of delayed AEs following EUS‐GBD. [ABSTRACT FROM AUTHOR]

Background and Aim: Endoscopic ultrasound‐guided gallbladder drainage (EUS‐GBD) is an emerging option for acute cholecystitis in non‐surgical candidates. Combining endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct stones with EUS‐GBD in a single session might become a non‐surgical management strategy to comprehensively treat gallstone disease in selected patients. Methods: Single‐center retrospective cohort study comparing outcomes between EUS‐GBD alone (group A) and single‐session ERCP combined with EUS‐GBD (group B). Consecutive patients who underwent EUS‐GBD with a lumen‐apposing metal stent (LAMS) between June 2011 and August 2018 were analyzed. Exclusion criteria were subjects included in randomized clinical trials, patients who had had ERCP within 5 days of EUS‐GBD, patients in whom ERCP or EUS‐GBD was carried out for salvage of one or the other procedure, and patients who underwent concurrent EUS‐guided biliary drainage. Results: One hundred and nine consecutive patients underwent EUS‐GBD with LAMS during the study period. Seventy‐one patients satisfied the inclusion criteria and 34 patients were in group A and 37 in group B. Baseline characteristics were similar in both groups. There were no significant differences in technical (97.1% vs 97.3%; P = 0.19) and clinical success rates (88.2% vs 94.6%; P = 0.42) of EUS‐GBD in group A versus group B. Rate of adverse events was similar in both groups, five (14.7%) in group A versus five (13.5%) in group B. Conclusions: Single‐session EUS‐GBD combined with ERCP has comparable rates of technical and clinical success to EUS‐GBD alone. A combined EUS‐GBD and ERCP procedure does not appear to increase adverse events and makes possible comprehensive treatment of gallstone disease by purely endoscopic means. [ABSTRACT FROM AUTHOR]

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 Cholecystectomy remains the gold standard treatment of cholecystitis. Endoscopic treatment of cholecystitis includes transpapillary gallbladder drainage. Recently, endoscopic ultrasound-guided transmural drainage of the gallbladder (EUS-GBD) has been reported. This study reports the cumulative experience of an international group performing EUS-GBD. Methods Cases of EUS-GBD from January 2012 to November 2013 from 3 tertiary-care institutions were captured in a registry. Patient demographics, disease characteristics, procedural and clinical outcomes were recorded. Results 35 patients (15 malignant, 20 benign) were included. Median age was 81 years (SD = 13.76 years), sixteen (46%) were males. Median follow-up was 91.5 days (SD = 157 days). Transmural access was obtained from the stomach ( n = 17) or duodenum ( n = 18). Stents placed included plastic ( n = 6), metal ( n = 20), or combination ( n = 7). Technical success was achieved in 91.4% ( n = 32). Immediate adverse events (14%) included: bleeding, stent migration, cholecystitis and hemoperitoneum. Delayed adverse events (11%) included abscess formation and recurrence of cholecystitis. Long-term clinical success rate was 89%. Stent type and puncture site were not associated with immediate ( p = 0.88, p = 0.62), or long-term ( p = 0.47, p = 0.27) success. Conclusions EUS-GBD appears to be feasible, safe, and effective. Prospective studies are needed to confirm these findings and identify the best technique to use. Clinical trial registration NCT01522573 . [ABSTRACT FROM AUTHOR]

INTRODUCTION: The study aimed to develop international consensus recommendations on the safe use of lumenapposing metal stents (LAMSs) for on- and off-label indications. METHODS: Based on the available literature, statements were formulated and grouped into the following categories: general safety measures, peripancreatic fluid collections, endoscopic ultrasound (EUS)- biliary drainage, EUS-gallbladder drainage, EUS-gastroenterostomy, and gastric access temporary for endoscopy. The evidence level of each statement was determined using the Grading of Recommendations Assessment, Development, and Evaluation methodology. International LAMS experts were invited to participate in a modified Delphi process. When no 80% consensus was reached, the statement was modified based on expert feedback. Statements were rejected if no consensus was reached after the third Delphi round. RESULTS: Fifty-six (93.3%) of 60 formulated statements were accepted, of which 35 (58.3%) in the first round. Consensus was reached on the optimal learning path, preprocedural imaging, the need for airway protection and essential safety measures during the procedure, such as the use of Doppler, and measurement of the distance between the gastrointestinal lumen and the target structure. Specific consensus recommendations were generated for the different LAMS indications, covering, among others, careful patient selection, the preferred size of the LAMS, the need for antibiotics, the preferred anatomic location of the LAMS, the need for coaxial pigtail placement, and the appropriate management of LAMS-related adverse events. DISCUSSION: Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS. [ABSTRACT FROM AUTHOR]