New study tests if draining the gallbladder early prevents repeat attacks in frail patients
NCT ID NCT05893511
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether draining the gallbladder using a thin tube passed through the mouth (EUS-GBD) right away is better than starting with antibiotics alone for elderly or very sick patients with mild to moderate gallbladder infection who cannot have surgery. About 110 participants will be randomly assigned to one of the two approaches. The main goal is to see if upfront drainage reduces the chance of another gallbladder infection within one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) procedure
- What this could lead to
- If successful, upfront drainage could become a standard treatment to prevent repeat gallbladder attacks in frail patients who cannot undergo surgery.
- What could go wrong
- This is a relatively small Phase 3 trial (110 patients), and the procedure carries risks like bleeding or infection. The benefit over antibiotics alone may not be large enough to change practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Chinese Universtiy of Hong Kong
RECRUITINGHong Kong, HONG KONG, 00000, Hong Kong
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Other studies related to the condition(s) this trial covers.
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