Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07792486

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

Conditions: Cholecystitis, Acute

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 212
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Location: Amsterdam UMC, location VUmc Amsterdam De Boelelaan 1118

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.

Eligibility Criteria

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 non-sealed perforated gallbladder. In case of a sealed perforation, patients can be included after assessment of an expert panel. * Need of dual treatment with both modalities, already established beforehand. * Prior gallbladder drainage attempts. * Surgically altered anatomy (i.e. alterations to the oesophagus, stomach and duodenum). * The presence of contraindications to either drainage modality, unless it is a temporary problem that can be mitigated beforehand (i.e. ascites drainage prior to percutaneous drainage). * Permanently incapacitated and therefore inability to fill out the quality of life surveys.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07792486). StuddyBuddy aggregates publicly available trial information.