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