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

Recruiting now · Phase 3

Conditions studied: Acute Cholecystitis

In brief

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.

Key facts

Study ID: NCT05893511
Run by: Chinese University of Hong Kong
People needed: 110
Starts: 2023-04-26
Expected to finish: 2027-12-31
Last updated by the study team: 2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Consecutive patients aged ≥ 18 years old
Suffering from grade 1 or 2 acute calculous cholecystitis*
At very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions** or elderly patients suffering from acute cholecystitis but refused operations

You may not qualify if…

Patients with the following conditions are excluded from the study:
Pregnancy
Patients unwilling to undergo follow-up assessments
Patients with suspected gangrene or perforation of the gallbladder
Grade III acute cholecystitis33
Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
Patients with liver cirrhosis, portal hypertension and/or gastric varices
Abnormal coagulation: International normalized ratio (INR) > 1.5 and/or platelets < 50.000/mm3
Previous drainage of the gallbladder
Patients suffering acute cholecystitis due to malignant cystic duct obstruction
Patients with life expectancy of less than 3 years

Where it is running

The Chinese Universtiy of Hong Kong — Hong Kong, HONG KONG, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.