Comparing EUS-guided gallbladder drainage to antibiotics for high-risk patients with acute cholecystitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Percutaneous vs. Endoscopic Gallbladder Drainage for those who aren’t surgery candidates

  This randomized trial tests two less-invasive gallbladder drainage methods to see which works better for people with acute gallbladder infection who aren’t candidates for surgery.

  Recruiting Orlando Health, Inc. · Orlando, Florida · NCT07696546

• Cholecystitis: EUS-guided Gallbladder Drainage vs Cyst removal by LCC in older adults

  In people aged 75 and up with acute cholecystitis, this study tests whether an endoscopic drainage procedure (EUS-GBD) works as well as the standard gallbladder removal surgery (LCC).

  Recruiting Oulu University Hospital · Oulu, Oulu · NCT07678541

• Deep learning rapid MRI for preoperative evaluation of acute cholecystitis.

  This will test whether a new fast abdominal MRI using deep learning can provide image quality comparable to standard MRI for adults with acute cholecystitis who need preoperative scans.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07551375

• Early versus delayed gallbladder removal after tube drainage for moderate or severe acute cholecystitis.

  This trial tests whether removing the gallbladder soon after a drainage tube is placed or waiting several weeks leads to fewer complications for adults with moderate or severe acute cholecystitis.

  Recruiting Chiang Mai University · Chiang Mai · NCT07161960

• One-year outcomes after different treatments for acute cholecystitis in people aged 70 and older

  This project will compare supportive care, drainage, and surgery for people 70 and older with acute cholecystitis to see which approach leads to better health and fewer repeat treatments after one year.

  Recruiting Instituto de Investigación Sanitaria y Biomédica de Alicante · Alicante, Alicante · NCT07006298

• Conservative versus proactive care after EUS-guided gallbladder drainage for acute cholecystitis

  This trial will test whether, for people with acute cholecystitis who cannot have surgery, keeping the endoscopic gallbladder stent in place long-term or doing regular endoscopic cleanings and removing the stent works better.

  Recruiting Hospital General Universitario de Alicante · Alicante, Alicante and 1 other locations · NCT06967597

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.