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Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Summary
The goal of this clinical trial is to learn if endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) works better than percutaneous gallbladder drainage (PT-GBD) for people with acute cholecystitis (inflammation of the gallbladder) who cannot undergo immediate surgery. The main questions this study aims to answer are: * Does EUS-GBD lead to fewer serious medical problems and fewer additional procedures within 30 days after treatment? * Does EUS-GBD improve quality of life compared with PT-GBD? Researchers will compare two methods of draining the gallbladder to see which treatment leads to better outcomes. Participants will: * Be randomly assigned to receive either EUS-GBD or PT-GBD. * Receive gallbladder drainage performed by experienced specialists. * Complete questionnaires about their health and quality of life before treatment and during follow-up. * Have follow-up visits or telephone consultations at 7, 30, 182, and 365 days after the drainage procedure. The study will include participants from hospitals in several (European) countries.
Official title: Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis: a Multicenter International Randomized Controlled Superiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
212
Start Date
2026-08-01
Completion Date
2029-10-01
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS)
Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) via transduodenal route and with the direct technique using a cautery-enhanced LAMS with co-axial 7Fr 3-7 cm pigtail stent through the LAMS, and linear echo-endoscope. * Absent gallbladder stones or stones \<10mm: 10x10 mm stent * Present gallbladder stones: 15x10 mm stent
Percutaneous gallbladder drainage
Percutaneous gallbladder drainage with Seldinger preferred technique using snographic and fluoroscopic guidance or cross-sectional imaging as needed. Preferred route is at the discretion of the interventional radiologist, as multiple recent studies have shown that transhepatic and transperitoneal approaches have similar outcomes. A needle according to physician preference may be used, with compatible guidewire, 8.5-10Fr pigtail catheter placed via an inter or subcostal approach.
Locations (1)
Amsterdam UMC, location VUmc
Amsterdam, De Boelelaan 1118, Netherlands