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EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy
Sponsor: Chinese University of Hong Kong
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.
Official title: Upfront Endoscopic Ultrasound-guided Gallbladder Drainage (EUS-GBD) Versus Standard Protocol (Antibiotics First) for Mild to Moderate Acute Cholecystitis in Patients Who Are Very-high-risk for Cholecystectomy: A Randomized-controlled Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2023-04-26
Completion Date
2027-12-31
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Endoscopic ultrasound-guided gallbladder drainage
Prior to the procedure, the patients would be kept fasted for 6 hours and antibiotics would be commenced (2nd generation cephalosporin or equivalent). EUS-GBD would be performed by either the conventional or direct method. A 10mm stent system would be used if the largest gallstone is smaller than 10mm in size and a 16mm stent is used if the largest gallstone is larger than 10mm. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder is completely emptied by suction and irrigation until the effluent through the stent is clean. The need of inserting an additional double pigtail plastic stent through the LAMS would be decided by the endosonographer. A course of antibiotics will be continued for 7 days after the procedure .
Antibiotics first
Patients randomized to antibiotics first would be given intravenous antibiotics 2nd generation cephalosporin or equivalent). Antibiotics would first be given parenterally and then switched to oral form when patient can tolerate diet or when sepsis subside. It will be continued for at least a total of 7 days.
Locations (1)
The Chinese Universtiy of Hong Kong
Hong Kong, HONG KONG, Hong Kong