Endoscopic ultrasound‐guided gallbladder drainage with long‐term lumen‐apposing metal stent indwell: 1‐year results from a prospective nationwide observational study

Abstract 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.