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New study tests if draining the gallbladder early prevents repeat attacks in frail patients

NCT ID NCT05893511

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • The Chinese Universtiy of Hong Kong

    RECRUITING

    Hong Kong, HONG KONG, 00000, Hong Kong

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