EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
Objectives Acute cholecystitis commonly occurs in elderly patients who are at high-risk for
surgery. Whether upfront Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is
advantageous over antibiotics first for mild acute cholecystitis is uncertain.
Hypothesis to be tested The aim is to compare EUS-GBD versus standard protocol (antibiotics
first) as a definitive treatment, in very high-risk patients suffering from mild to moderate
acute cholecystitis. We hypothesize that EUS-GBD can reduce the 1-year risk of recurrent
acute cholecystitis.
Design and subjects This is an international randomised controlled study including
consecutive patients suffering from acute cholecystitis that are very high-risk for
cholecystectomy. The patients would be randomized to receive EUS-GBD or antibiotics first.
Interventions: EUS-GBD versus antibiotics
Main outcome measures:
The primary outcome is the rate of recurrent acute cholecystitis in 1 year. Other outcomes
include technical and clinical success, post-procedural pain scores, analgesic requirements,
adverse events, re-admissions, re-interventions, quality of life and cost analysis.
Data analysis All outcomes would be analysed according to the intention-to-treat principle.
Kaplan-Meier method with the log-rank test will be used to compare differences in recurrent
acute cholecystitis in 1 year. A health economic analysis will also be performed. Assuming a
17.1% difference in recurrent acute cholecystitis rates, a 2-sided P value of 0.05, a power
of 80%, and a 10% dropout rate, 110 patients is required.
Expected results The findings of this study can help establish the role of EUS-GBD in
management of high-risk patients suffering from acute cholecystitis over antibiotics alone
and Percutaneous transhepatic gallbladder drainage.