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New endoscopic procedure may offer better Long-Term relief for gallbladder patients too sick for surgery

NCT ID NCT07575360

Disease control Sponsor: University of Bologna 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 484 high-risk surgical patients with acute cholecystitis (gallbladder inflammation) who first received a standard drainage tube through the skin. Some then had a newer procedure using an endoscope to place a metal stent inside the gallbladder. Researchers compared long-term outcomes like repeat infections and need for further procedures. The goal is to find a safer, more effective way to manage these patients.

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 with a metal stent
What this could lead to
If successful, this approach could offer a safer, long-term alternative to standard drainage tubes for high-risk patients with gallbladder inflammation.
What could go wrong
This is a retrospective observational study, not a randomized trial, so results may be less reliable. The procedure carries 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.

Participants

484 people

The number who actually took part.

Started

Apr 2024

Finished

Sep 2025

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

The study population includes adult patients (≥18 years) with acute cholecystitis who were considered high-risk for surgery and managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). All patients were deemed unfit for cholecystectomy after multidisciplinary evaluation. Eligible patients are retrospectively identified from participating centers and include all consecutive cases undergoing PT-GBD during the study period. The population reflects a real-world cohort of frail patients with significant comorbidities. Two groups are defined based on subsequent management: conversion to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stent (LAMS) versus standard management.

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 * Patients considered unfit for surgery after multidisciplinary discussion * Patients who underwent PT-GBD for acute cholecystitis Exclusion Criteria: * Patients with improved general conditions who become fit for laparoscopic cholecystectomy * Use of anticoagulants that cannot be discontinued * Coagulation and/or platelet hereditary disorders and/or INR \>1.5, PLT \<50,000 * Absolute contraindication for EUS-GBD * Post-surgical altered upper gastrointestinal anatomy * Malignant biliary obstruction

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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

Contacts and locations

Locations

  • Gastroenterology Unit, Hospital of Imola

    Imola, 40026, Italy

More trials for these conditions

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