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New drainage procedure could prevent gallbladder attacks without surgery

NCT ID NCT07655778

Disease control Sponsor: Hospital Mutua de Terrassa 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether a procedure called EUS-guided gallbladder drainage can prevent future gallbladder attacks in people who are too sick or frail for surgery. Participants are randomly assigned to receive either the drainage procedure or standard medical care. The study will track how many people in each group have a new gallbladder-related event over 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
EUS-guided gallbladder drainage with lumen-apposing metal stent
What this could lead to
If effective, this procedure could offer a non-surgical option to prevent recurrent gallbladder attacks in people who cannot undergo surgery.
What could go wrong
This is a relatively small, early-stage trial, and the procedure carries risks such as bleeding, infection, or stent migration. It may not prove superior to conservative care.

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 110 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

Jul 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: * Patients ≥ 18 years of age * Patients who have experienced a benign biliary event (biliary colic, acute pancreatitis, cholangitis, or choledocholithiasis) and are candidates for elective cholecystectomy * Patients deemed unfuit for surgery (age ≥ 80 years, ASA score ≥ 3, Charlson Comorbidity Index ≥ 5) or who voluntarily refuse surgery * Diagnosis of lithogenic/lithiasic material in the gallbladder by imaging (biliary sludge, microlithiasis, and/or cholelithiasis) * Signed informed consent Exclusion Criteria: * No signed informed consent * Prior cholecystectomy * Biliary event secondary to malignant etiology * Acute cholecystitis diagnosed according to Tokyo 2018 criteria * Moderate-to-severe ascites without prior paracentesis * Perforated gallbladder * Severe coagulopathy (INR \> 1.5) or thrombocytopenia (platelets \< 50,000/μL) not correctable * Any clinical condition preventing sedation * Patient dependent for daily activities (ECOG ≥ 4)

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Conditions

The condition(s) this trial relates to.

acute pancreatitis biliary dyskinesia cholangitis choledocholithiasis cholelithiasis gallbladder disorder

As listed by the trial registrant

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

Acute pancreatitis due to common bile duct calculus Acute pancreatitis due to gallstones Biliary colic Cholangitis; choledocholithiasis Cholecystectomy Cholelithiasis Endoscopic ultrasound (EUS) Gallbladder

How to take part

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

  1. 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 ↗

  2. 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.

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