Comparing Endoscopic Ultrasound-Guided Gallbladder Drainage to Antibiotics for Treating Mild to Moderate Acute Cholecystitis in High-Risk Patients

What this Trial Is About

Researchers are comparing two treatment approaches for mild to moderate acute cholecystitis in patients who are very high-risk for surgery. This international randomized controlled trial aims to evaluate whether upfront endoscopic ultrasound-guided gallbladder drainage EUS-GBD can reduce the one-year risk of recurrent acute cholecystitis compared to the standard antibiotic treatment. The study is sponsored by the Chinese University of Hong Kong and includes patients who cannot easily undergo surgery due to poor health or age. Participants are randomly assigned to one of two groups the EUS-GBD group or the antibiotics-first group. Those in the antibiotics group receive intravenous second-generation cephalosporin or equivalent antibiotics initially, which may switch to oral antibiotics after the patient can tolerate food or sepsis subsides, continued for at least seven days. The EUS-GBD procedure involves fasting for six hours before the procedure, antibiotic use starting beforehand, and placement of a stent to drain the gallbladder, followed by another week of antibiotics. The procedure uses either a 10mm or 16mm stent depending on gallstone size, with gallbladder contents suctioned and irrigated until clear. During the study, participants will be monitored for technical and clinical success, pain levels, analgesic use, adverse events, hospital readmissions, and the need for further interventions. Quality of life and cost-effectiveness will also be assessed over one year. Follow-up will include clinical and laboratory evaluations to measure outcomes. The primary outcome is the rate of recurrent acute cholecystitis within one year. Data will be analyzed using intention-to-treat methods, with safety and efficacy tracked throughout the study period.

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