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New study tests endoscopic gallbladder drainage as surgery alternative

NCT ID NCT07649811

Disease control Sponsor: Air Force Military Medical University, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will follow 220 patients with benign gallbladder diseases who cannot have surgery. It compares two non-surgical approaches: endoscopic drainage with possible stone removal versus traditional drainage alone. The goal is to see which method leads to fewer complications and better long-term outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endoscopic gallbladder drainage (EUS-GBD) with possible stone removal
What this could lead to
If successful, this could show that endoscopic drainage with stone removal is safer and more effective than long-term drainage alone, helping high-risk patients avoid surgery.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The procedures carry risks like bleeding, infection, or bile leak.

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.

Participants

About 220 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

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.

Who is studied

high-risk acute cholecystitis patients ineligible for surgery, or patients with benign gallbladder diseases who have a strong preference and clinical requirement for gallbladder-preserving therapy

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: * Age ≥ 18 years, and voluntarily signed the informed consent form; * Radiologically confirmed symptomatic benign gallbladder disease (symptomatic gallbladder stones, gallbladder polyps meeting surgical indications, acute cholecystitis TG18 Grade I/II); and meeting any of the following specific population criteria: 1. High-risk surgical patients: ASA classification ≥ III, or presence of severe comorbidities that significantly increase the risk of laparoscopic cholecystectomy (LC); 2. Patients with concomitant common bile duct stones (CBDS) and a strong desire for gallbladder preservation: presence of CBDS confirmed by MRCP/ERCP examination, and still strongly requesting the preservation of gallbladder function after being fully informed. Exclusion Criteria: * Suspected or confirmed gallbladder malignancy; * Complications requiring emergency surgical intervention (gangrene, perforation, diffuse peritonitis); * Uncorrectable severe coagulation dysfunction; * Presence of severe anatomical deformity or obstruction of the stomach, duodenum, or esophagus, where the endoscope is expected to be unable to reach the target site (papilla or pericholecystic area); * Significant gallbladder atrophy (longitudinal diameter \< 4 cm or anteroposterior diameter \< 2 cm); * Pregnant or lactating women; * Previous history of cholecystectomy; * Presence of psychiatric disorders or any condition that prevents cooperation with treatment and follow-up; * Unwilling or unable to sign the informed consent form.

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Conditions

The condition(s) this trial relates to.

acute cholecystitis cholelithiasis gallbladder disorder polyp of gallbladder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholecystitis, acute Cholelithiasis Gallbladder diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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.

    Open the record ↗

  3. 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

  • Xijing Hospital of Digestive Diseases

    Xi'an, Shaanxi, 710000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.