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Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis

NCT07781722 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-08-24

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a single intravenous dose of tacrolimus, given before an ERCP procedure (an endoscopic procedure of the bile ducts and pancreas), can prevent post-ERCP pancreatitis (PEP) in adults at moderate-to-high risk of developing this complication.

The main question it aims to answer is:

* Does a single dose of tacrolimus lower the number of participants who develop pancreatitis after ERCP?

Researchers will compare tacrolimus to a placebo (a look-alike solution with no active drug) to see if tacrolimus reduces the occurrence of PEP.

Participants will:

* Receive an intravenous infusion of either tacrolimus or placebo, given over 60 minutes, ending before the start of the ERCP procedure
* Receive standard preventive treatment (a rectal anti-inflammatory medication (NSAID)) in addition to the study infusion
* Be contacted by phone 48 hours after the procedure to check for symptoms
* Complete questionnaires about quality of life and healthcare use, and be followed for 12 weeks after the procedure
* The first 40 enrolled patients will have extra blood samples taken to measure tacrolimus levels.

Conditions

  • Post-ERCP Pancreatitis

Interventions

DRUG

Tacrolimus

A single intravenous dose of tacrolimus, completed before the start of ERCP.

OTHER

NaCl (placebo)

A matching intravenous placebo, identical in appearance and administration to the tacrolimus infusion.

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-07
Primary Completion
2028-09-07
Completion
2028-12-07

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781722 on ClinicalTrials.gov