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Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis

NCT07792486 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2026-08-28

No results posted yet for this study

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.

Conditions

  • Cholecystitis, Acute

Interventions

PROCEDURE

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

PROCEDURE

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.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Rogier P Voermans, Gastroenterologist, MD, PhD · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-10-01
Completion
2029-10-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792486 on ClinicalTrials.gov