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NCT Number: NCT07781722

Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis

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.

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Key information

Conditions

Post-ERCP Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amsterdam UMC, Location VUmc

Amsterdam, Netherlands

Location contact

Malin Witteman

CONTACT

[email protected]

088-3207054

Mattheus Wielenga, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tacrolimus

Drug

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

NaCl (placebo)

Other

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

Primary outcomes

  1. Post-ERCP Pancreatitis (PEP)

    Time frame: 48 hours after ERCP

    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.

Secondary outcomes

  1. Incidence of Post-ERCP Pancreatitis within 30 days

    Time frame: Within 30 days after ERCP

  2. Severity of PEP

    Time frame: Up to 30 days after ERCP

    Severity of Post-ERCP Pancreatitis± According to the revised Atlanta classification (mild, moderate, severe)

  3. ERCP-related complications

    Time frame: Up to 30 days after ERCP

    Incidence of ERCP-related complications other than PEP

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

    Time frame: Up to 30 days after ERCP

  5. Hospital/ICU stay

    Time frame: Up to 12 weeks

    Length of hospital and ICU stay

  6. Change in quality of life as measured by EQ-5D-5L

    Time frame: Baseline, 48 hours, and 12 weeks after ERCP

  7. Healthcare costs

    Time frame: Up to 12 weeks after ERCP

    Healthcare consumption and societal costs

Study contacts

Contact information is provided by the study sponsor or research team.

Malin Witteman, MD

CONTACT

[email protected]

+31 88 3207054

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis: a DPSG (Dutch Pancreatitis Study Group) Multicenter, Double-blind, Randomized, Placebo-controlled Study.

Acronym: TacroProph

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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