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One-Time drug infusion may shield the pancreas after ERCP

NCT ID NCT07781722

Prevention Sponsor: Amsterdam UMC, location VUmc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests whether a single intravenous dose of tacrolimus, given just before an ERCP procedure, can lower the chance of developing post-ERCP pancreatitis (PEP) in adults at moderate-to-high risk. Participants receive either tacrolimus or a placebo infusion, along with standard preventive care, and are monitored for symptoms for 48 hours and followed for 12 weeks. The study aims to see if this drug can safely reduce the occurrence of this painful complication.

What this could mean

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

Active substance
tacrolimus
What this could lead to
If effective, this could offer a simple, one-time preventive treatment to reduce the risk of pancreatitis after ERCP, a common and potentially serious complication.
What could go wrong
This is a phase 4 trial, but the outcome is not guaranteed. The drug may not reduce pancreatitis risk, and there are potential side effects, including allergic reactions or kidney issues, especially in people with certain health conditions.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 520 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

Accepted

You do not need to have the condition being studied to take part.

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 or older * Indication for ERCP * Ability to provide written informed consent Exclusion Criteria: * Previous sphincterotomy or sphincteroplasty * Routine biliary stent exchange * Altered anatomy or biliodigestive anastomosis * Chronic pancreatitis according to the M-ANNHEIM criteria * Active pancreatitis * Sepsis or ASA IV * Contraindication for tacrolimus or diclofenac (allergy, potassium \>5 mmol/L, eGFR \<30 mL/min) * Pregnancy or breastfeeding * Current tacrolimus or ciclosporin use * Current use of medications contraindicated with tacrolimus, including strong CYP3A4/3A5 inhibitors (e.g., ketoconazole, voriconazole, posaconazole, itraconazole, clarithromycin, josamycin, ritonavir, cobicistat) or CYP3A4/3A5 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's wort)

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Conditions

The condition(s) this trial relates to.

acute pancreatitis

As listed by the trial registrant

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

Post-ercp pancreatitis

How to take part

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  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

  • Amsterdam UMC, Location VUmc

    Amsterdam, Netherlands

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