EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy

PHASE3RecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

April 26, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Acute Cholecystitis
Interventions
PROCEDURE

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 .

DRUG

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.

Trial Locations (1)

00000

RECRUITING

The Chinese Universtiy of Hong Kong, Hong Kong

All Listed Sponsors
lead

Chinese University of Hong Kong

OTHER