NCT07781722

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_4

Timeline
27mo left

Started Sep 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

September 7, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2028

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 19, 2026

Last Update Submit

August 19, 2026

Conditions

Post-ERCP Pancreatitis

Keywords

Post-ERCP pancreatitisTacrolimusEndoscopic retrograde cholangiopancreatographyProphylaxisERCP

Outcome Measures

Primary Outcomes (1)

  • Post-ERCP Pancreatitis (PEP)

    Occurrence of post-ERCP pancreatitis within 48 hours after ERCP, defined according to the revised Atlanta criteria: ≥2 of the following: (a) characteristic abdominal pain; (b) serum amylase or lipase \>3× upper limit of normal; (c) imaging findings consistent with pancreatitis.

    48 hours after ERCP

Secondary Outcomes (7)

  • Incidence of Post-ERCP Pancreatitis within 30 days

    Within 30 days after ERCP

  • Severity of PEP

    Up to 30 days after ERCP

  • ERCP-related complications

    Up to 30 days after ERCP

  • Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Reactions

    Up to 30 days after ERCP

  • Hospital/ICU stay

    Up to 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Tacrolimus

EXPERIMENTAL

Participants receive a single intravenous dose of tacrolimus, completed before the start of ERCP. All participants also receive standard prophylactic care with rectal diclofenac 100 mg.

Drug: Tacrolimus

Placebo

PLACEBO COMPARATOR

Participants receive a matching intravenous placebo, identical in appearance and administration to the tacrolimus arm. All participants also receive standard prophylactic care with rectal diclofenac 100 mg.

Other: NaCl (placebo)

Interventions

TacrolimusDRUG

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

Tacrolimus
NaCl (placebo)OTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Indication for ERCP
  • Ability to provide written informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, Location VUmc

Amsterdam, Netherlands

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Central Study Contacts

Malin Witteman, MD

CONTACT

+31 88 3207054m.witteman1@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 24, 2026

Study Start (Estimated)

September 7, 2026

Primary Completion (Estimated)

September 7, 2028

Study Completion (Estimated)

December 7, 2028

Last Updated

August 24, 2026

Record last verified: 2026-08

Locations

NL(1)