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When to remove the gallbladder after severe pancreatitis? new trial seeks answers

NCT ID NCT06113419

Disease control Sponsor: Hospital Universitario Mayor Méderi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This trial looks at whether removing the gallbladder early (during the same hospital stay) or waiting 4 weeks after recovery is better for people with severe pancreatitis caused by gallstones. About 134 adults will be randomly assigned to one of the two timing options. The main goal is to see which approach leads to fewer major complications and less return of gallbladder-related problems.

What this could mean

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

Active substance
laparoscopic cholecystectomy (gallbladder removal surgery)
What this could lead to
If it works, this could show that early gallbladder removal is safer and reduces complications for people with severe pancreatitis.
What could go wrong
This is a relatively small trial (134 people) and results may not apply to all patients. Surgery always carries risks like infection or bleeding.

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 134 people

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

Started

Apr 2024

Expected to finish

Jun 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.

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, diagnosis of pancreatitis according to Atlanta guidelines, moderately severe or severe pancreatitis (APACHE score ≥8 on admittance) * Biliary pancreatitis diagnosed on imaging (be it ultrasound, magnetic resonance imaging and/or tomography) * Recovery of pancreatitis by tolerance of oral intake (defined as 24 hours of food consumption of any consistency without emetic episodes and pain defined as 4/10 on the visual analogue score of pain) and written informed consent. Exclusion Criteria: * Pregnancy * History of cholecystectomy * Planned open cholecystectomy * Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage) * Chronic pancreatitis, * More than one episode of pancreatitis * Active malignant disease * Septic shock * Choledocholithiasis not resolved by ERCP, post-ERCP perforation and post-ERCP concomitant pancreatitis.

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Conditions

The condition(s) this trial relates to.

acute pancreatitis cholelithiasis pancreatitis

As listed by the trial registrant

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

Acute pancreatitis Cholelithiasis

How to take part

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

  1. The places running it

    2 sites. 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

  • Hospital Universitario Mayor-Méderi

    RECRUITING

    Bogota, Cundinamarca, 111221, Colombia

  • Hospital Universitario Méderi Barrios Unidos

    RECRUITING

    Bogota, Cundinamarca, 111221, Colombia

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