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Can a Scope-Based drainage beat the needle for gallbladder infections?

NCT ID NCT07792486

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether draining the gallbladder through an endoscope works better than the standard percutaneous approach for people with acute cholecystitis who are too sick for surgery. Researchers will randomly assign 212 participants to receive either endoscopic ultrasound-guided drainage with a metal stent or percutaneous drainage through the skin. The study tracks serious complications, the need for extra procedures, and quality of life over a year. The goal is to find which method offers a safer, more comfortable recovery.

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) with lumen-apposing metal stents, compared to percutaneous gallbladder drainage (PT-GBD)
What this could lead to
If EUS-guided drainage proves better, it could become the preferred option for people with acute cholecystitis who cannot have surgery, leading to fewer complications and a better quality of life.
What could go wrong
This is a randomized trial, but the outcome depends on the skill of the specialists and the specific condition of each patient. The results may not apply to all hospitals or patients, and both procedures carry risks like bleeding or infection.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 212 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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: * ≥ 18 years * Definite diagnosis of acute cholecystitis following the Tokyo guidelines * Poor surgical patients, not eligible for acute cholecystectomy according to their surgeon, with indication for gallbladder drainage.b The reason for ineligibility is recorded. * Possibility to obtain written informed consent from the patient or their legal representative. * Drainage with both modalities is technically feasible (i.e. the gallbladder can be accessed with both techniques), as assessed by the treating physician and/or expert panel. Exclusion Criteria: * Presence of a non-sealed perforated gallbladder. In case of a sealed perforation, patients can be included after assessment of an expert panel. * Need of dual treatment with both modalities, already established beforehand. * Prior gallbladder drainage attempts. * Surgically altered anatomy (i.e. alterations to the oesophagus, stomach and duodenum). * The presence of contraindications to either drainage modality, unless it is a temporary problem that can be mitigated beforehand (i.e. ascites drainage prior to percutaneous drainage). * Permanently incapacitated and therefore inability to fill out the quality of life surveys.

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Conditions

The condition(s) this trial relates to.

acute cholecystitis

As listed by the trial registrant

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

Cholecystitis, acute

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

  • Amsterdam UMC, location VUmc

    Amsterdam, De Boelelaan 1118, 1081 HV, Netherlands

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