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New endoscopic drainage may spare elderly patients from gallbladder surgery

NCT ID NCT07678541

Disease control Sponsor: Oulu University Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study compares two treatments for acute cholecystitis (inflamed gallbladder) in patients aged 75 and older. One is the standard laparoscopic surgery to remove the gallbladder. The other is a newer, less invasive procedure called EUS-guided gallbladder drainage, where a small tube is placed through the stomach or intestine to drain the gallbladder. The goal is to see if the drainage procedure works as well as surgery, with fewer risks for older patients who may have other health problems.

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 stent
What this could lead to
If successful, this could offer a safer, less invasive alternative to surgery for elderly patients with acute cholecystitis, reducing recovery time and complications.
What could go wrong
This is a relatively small, early-stage trial. The endoscopic procedure may have higher recurrence rates or its own complications, and results may not apply to all elderly patients.

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 116 people

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

Started

Feb 2026

Expected to finish

Feb 2036

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

75 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 75 years or older. * Radiologically confirmed acute cholecystitis. * Elevated inflammatory parameters. * Able to provide written informed consent. * Able to complete follow-up questionnaires. Exclusion Criteria: * Age under 75 years. * Considered unfit for surgery. * ASA physical status classification below III. * Unwillingness to participate in follow-up assessments. * Lack of written informed consent. * Clinical Frailty Scale score of 8 or higher.

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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.

Acute cholecystitis

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

  • Oulu University Hospital

    RECRUITING

    Oulu, Oulu, 90220, Finland

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