Comparing Two Minimally Invasive Treatments for Acute Calculous Cholecystitis in Patients Unsuitable for Surgery Percutaneous Cholecystostomy Versus Endoscopic Ultrasound-Guided Gallbladder Drainage

What this Trial Is About

This research investigates two minimally invasive treatments for patients with acute calculous cholecystitis who are not candidates for surgery due to frailty or other health issues. The study compares percutaneous cholecystostomy PC, a traditional external drainage method, with endoscopic ultrasound-guided gallbladder drainage EUS-GBD, which uses an internal metal stent. The goal is to evaluate treatment outcomes and quality of life over a 36-month follow-up period. Participants are randomly assigned to receive either PC, involving catheter placement through the skin into the gallbladder, or EUS-GBD, where a stent is placed endoscopically to allow internal drainage. Both procedures are performed by specialized medical teams. The study includes a long-term follow-up to compare the safety, complications, reinterventions, readmissions, and costs between these two approaches. Throughout the study, participants will be monitored regularly with assessments including adverse events, readmissions, organ function, and quality of life measures up to 36 months after treatment. Researchers will track a composite primary outcome combining procedure-related adverse events, reinterventions, and readmissions. Additional evaluations involve mortality at 30 days, disease recurrence, technical and clinical success, and overall treatment costs. The study aims to provide comprehensive data on the best management for this high-risk patient group.

Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage