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

Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis: a Multicenter International Randomized Controlled Superiority Trial

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 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.