Actively Recruiting
Endoscopic Ultrasound-guided Gallbladder Drainage Versus Antibiotics for Mild to Moderate Acute Cholecystitis in Very High-risk Patients for Cholecystectomy: A Randomized Controlled Trial
Led by Chinese University of Hong Kong · Updated on 2026-04-07
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosed with grade 1 or 2 acute calculous cholecystitis
- Considered very high-risk for early laparoscopic cholecystectomy due to poor health or elderly patients who refuse surgery
You will not qualify if you...
- Pregnant patients
- Patients unwilling to undergo follow-up assessments
- Patients with suspected gangrene or perforation of the gallbladder
- Patients with grade III acute cholecystitis
- Patients with liver abscess or pancreatitis
- Patients with altered upper gastrointestinal tract anatomy from surgery
- Patients with liver cirrhosis, portal hypertension, or gastric varices
- Abnormal blood clotting (INR > 1.5 or platelets < 50,000/mm3)
- Patients who previously had gallbladder drainage
- Patients with acute cholecystitis due to malignant cystic duct obstruction
- Patients with life expectancy less than 3 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 7 days
Participants receive either endoscopic ultrasound-guided gallbladder drainage with continued antibiotics for up to one week after the procedure or intravenous antibiotics initially, switching to oral antibiotics, continued for at least 7 days.
1 procedure visit for drainage group; daily visits or assessments for up to 7 days for antibiotic group
Duration - Up to 1 year
Participants are monitored for up to 1 year to assess recurrence of acute cholecystitis, adverse events, clinical success, and quality of life.
Multiple follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
The Chinese Universtiy of Hong Kong
Hong Kong, HONG KONG, Hong Kong, 00000
Actively Recruiting
Research Team
S
Shannon Melissa Chan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here