Comparing Long-Term Strategies for Gallbladder Drainage After Endoscopic Ultrasound-Guided Treatment of Acute Cholecystitis in High-Risk Patients

What this Trial Is About

This research aims to compare two follow-up strategies for patients with acute cholecystitis who cannot undergo surgery due to high risk. The study focuses on patients who receive gallbladder drainage using a lumen-apposing metal stent LAMS guided by endoscopic ultrasound EUS. Researchers want to determine whether maintaining the metal stent indefinitely or performing periodic procedures to remove gallstones and eventually replace the stent leads to better clinical outcomes over one year. Participants will be randomly assigned to one of two groups. One group will have the metal stent left in place indefinitely to ensure continuous bile drainage and prevent new cholecystitis episodes. The other group will undergo elective endoscopic procedures starting one month after drainage to clean the gallbladder, remove stones, and replace the metal stent with a thin plastic catheter. These cleaning procedures may occur weekly until the gallbladder is clear. During the study, participants will have clinical evaluations and lab tests shortly after drainage, followed by scheduled check-ins at 1, 6, 9, and 12 months, either in person or remotely. Researchers will monitor complications, biliopancreatic events, hospital admissions, quality of life, and mortality. The main outcome measured is the rate of biliopancreatic events within a year. The study aims to provide evidence on which management approach results in fewer complications and better patient outcomes.

Conservative Versus Proactive Management of Acute Cholecystitis After EUS-guided Transmural Gallbladder Drainage: FUGITIVE Trial (FUGITIVE)