NCT05893511 EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy
| NCT ID | NCT05893511 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Acute Cholecystitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-04-26 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 110 participants in total. It began in 2023-04-26 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Shannon Melissa Chan
PRINCIPAL INVESTIGATOR
The Chinese Universtiy of Hong Kong
Frequently Asked Questions
Who can join the NCT05893511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Cholecystitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05893511 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 110 participants.
Is NCT05893511 currently recruiting?
Yes, NCT05893511 is actively recruiting participants. Contact the research team at shannonchan@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT05893511 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT05893511 clinical trial?
NCT05893511 is sponsored by Chinese University of Hong Kong. The principal investigator is Shannon Melissa Chan at The Chinese Universtiy of Hong Kong. The trial plans to enroll 110 participants.