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Could a simple pill prevent a painful complication after endoscopy?

NCT ID NCT05252754

Prevention Sponsor: Johns Hopkins University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding an oral medication (tacrolimus) before an ERCP procedure can prevent pancreatitis, a painful inflammation of the pancreas that sometimes occurs afterward. About 4,800 adults undergoing ERCP will be randomly assigned to receive either the standard rectal medication alone or the standard medication plus oral tacrolimus. The goal is to see if the combination reduces the number of people who develop pancreatitis after the procedure.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 4,874 people

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

Started

Jan 2023

Expected to finish

Dec 2026

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: * Any patient who is undergoing endoscopic retrograde cholangiopancreatography (ERCP) at any of the participating centers, is at least 18 years old and provides informed consent can be included in the study. Exclusion Criteria: * Unwillingness or inability to consent for the study. * Pregnancy * Breastfeeding mother * Chronic calcific pancreatitis * ERCP for biliary stent exchange or removal * ERCP in a patient with prior biliary sphincterotomy, but without anticipated pancreatogram. * Biliary intervention in a patient with pancreas divisum. * Standard contraindications to tacrolimus or NSAID use. * Current tacrolimus or immune modulator use. * Chronic kidney disease with glomerular filtration rate (GFR) \< 30 or acute kidney injury. * Absence of rectum. * Acute pancreatitis within 30 days of ERCP. * Pancreatic head malignancy. * Sphincter of Oddi dysfunction (Type 3).

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Conditions

The condition(s) this trial relates to.

acute pancreatitis prevention target

As listed by the trial registrant

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

Post-ercp acute pancreatitis

How to take part

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

  1. The places running it

    5 sites in 3 countries. 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

  • Apollo Multispecialty Hospitals,

    NOT_YET_RECRUITING

    Kolkata, West Bengal, 700054, India

  • Asian Institute of Gastroenterology

    RECRUITING

    Hyderabad, Andhra Pradesh, 500082, India

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Post Graduate Institute of Medical Education and Research

    NOT_YET_RECRUITING

    Chandigarh, 160012, India

  • Singapore General Hospital

    NOT_YET_RECRUITING

    Singapore, 169608, Singapore

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