Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
Inclusion Criteria: * ≥ 18 years * Definite diagnosis of acute cholecystitis following the Tokyo guidelines * Poor surgical patients, not eligible for acute cholecystectomy according to their surgeon, with indication for gallbladder drainage.b The reason for ineligibility is recorded. * Possibility to obtain written informed consent from the patient or their legal representative. * Drainage with both modalities is technically feasible (i.e. the gallbladder can be accessed with both techniques), as assessed by the treating physician and/or expert panel. Exclusion Criteria: * Presence of a no…
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 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.