Comparing EUS-guided gallbladder drainage to antibiotics for high-risk patients with acute cholecystitis
Upfront Endoscopic Ultrasound-guided Gallbladder Drainage (EUS-GBD) Versus Standard Protocol (Antibiotics First) for Mild to Moderate Acute Cholecystitis in Patients Who Are Very-high-risk for Cholecystectomy: A Randomized-controlled Trial.
This study is testing whether draining the gallbladder using a special ultrasound technique works better than antibiotics for high-risk patients with acute cholecystitis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, HONG KONG) |
| Trial ID | NCT05893511 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) compared to a standard antibiotic treatment in patients at very high risk for surgery due to mild to moderate acute cholecystitis. The study will randomly assign participants to receive either EUS-GBD or antibiotics first, with the primary goal of determining the rate of recurrent acute cholecystitis within one year. This international randomized controlled trial will include patients aged 18 and older who meet specific inclusion criteria related to their health status and the severity of their condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older suffering from mild to moderate acute calculous cholecystitis who are at very high risk for surgery.
Not a fit: Patients with severe acute cholecystitis, those with certain comorbidities, or those unwilling to participate in follow-up assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for high-risk patients, potentially reducing the recurrence of acute cholecystitis.
How similar studies have performed: While the approach of EUS-GBD is gaining attention, this specific comparison against antibiotics in high-risk patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong, HONG KONG
- The Chinese Universtiy of Hong Kong — Hong Kong, Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Shannon Melissa Chan — The Chinese Universtiy of Hong Kong
- Study coordinator: Shannon Melissa Chan
- Email: shannonchan@surgery.cuhk.edu.hk
- Phone: 35052627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.