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

RecruitingPhase 3Ages 18 Years - anyAllChinese University of Hong Kong
NCT05893511 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 outcom

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Consecutive patients aged ≥ 18 years old 2. Suffering from grade 1 or 2 acute calculous cholecystitis\* 3. At very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions\*\* or elderly patients suffering from acute cholecystitis but refused operations Exclusion Criteria: 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
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What it tests

  • Endoscopic ultrasound-guided gallbladder drainage
  • Antibiotics first
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Where

1 site
The Chinese Universtiy of Hong Kong
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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