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Tacrolimus for prevention of post-ERCP pancreatitis in moderate- to high-risk patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study examines Post-ERCP Pancreatitis, a swelling of the pancreas that can happen after a special X‑ray exam called ERCP. The medication being tested is a single dose of tacrolimus given as an intravenous infusion before the exam, and it is compared with a harmless solution known as placebo.

The purpose of the study is to determine whether this dose of the drug reduces the likelihood of developing pancreatitis after the procedure. Participants receive the infusion shortly before the ERCP, remain in the hospital for observation, and are checked for abdominal pain, blood test results, and any imaging signs of pancreatitis for up to 48 hours, with additional follow‑up for about a month to monitor any complications or side effects.

After the initial monitoring period, participants may have brief clinic visits or phone calls to assess recovery, quality of life, and any additional medical care needed. A small number of participants will also have blood drawn to measure drug levels, helping researchers understand how the medicine behaves in the body.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    After giving informed consent, you will provide basic health information and undergo initial assessments required for the study.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either tacrolimus (the active medication) or a placebo (sodium chloride solution). the assignment is concealed so you will not know which one you receive.

  3. Step 3

    Intravenous infusion of study medication

    A single dose of the assigned medication will be given through an intravenous line.

    If you receive tacrolimus, the infusion contains the drug at a concentration of 3 mg/ml and is administered over 30–60 minutes.

    If you receive the placebo, a 250 ml solution of 0.9 % sodium chloride will be infused over the same period.

    The infusion is completed before the scheduled ercp procedure.

  4. Step 4

    Ercp procedure

    Shortly after the infusion, you will undergo ercp (endoscopic retrograde cholangiopancreatography), a diagnostic and therapeutic procedure performed by a gastroenterologist.

  5. Step 5

    Immediate post‑procedure monitoring

    You will be observed in the hospital for at least 48 hours after ercp.

    Medical staff will check for abdominal pain, measure blood levels of amylase or lipase (enzymes that rise in pancreatitis), and may perform imaging if needed.

    Any signs of post‑ericp pancreatitis will be recorded according to standard criteria.

  6. Step 6

    Hospital stay and safety assessments

    During the hospital stay, vital signs and possible side effects will be monitored regularly.

    If you are part of the pharmacokinetic cohort (first 40 participants), additional blood samples will be taken to measure whole‑blood concentrations of tacrolimus.

  7. Step 7

    Discharge and 30‑day follow‑up

    After the 48‑hour observation period, you may be discharged home with instructions to report any new symptoms.

    A follow‑up assessment will be scheduled within 30 days after ercp to evaluate any delayed pancreatitis, complications, or adverse events.

  8. Step 8

    Extended follow‑up up to 12 weeks

    You will be asked to complete quality‑of‑life questionnaires (eq‑5d‑5l) and health‑care utilization surveys up to 12 weeks after the procedure.

    These questionnaires help assess the impact of the study on daily living and any additional medical visits.

Who can join the trial?

4 criteria

  • Be at least 18 years old.
  • Have a medical reason to undergo ERCP (a special test that looks at the tubes that carry digestive juices from the liver and pancreas).
  • Be able to sign a written informed consent form, meaning you understand the study and agree to take part.
  • Both men and women are allowed to participate.

Who cannot join the trial?

10 criteria

  • Having had a previous sphincterotomy or sphincteroplasty (procedures that cut or widen the opening of the bile duct).
  • Currently taking medicines that should not be used with tacrolimus, such as strong CYP3A4/3A5 inhibitors (e.g., ketoconazole, clarithromycin) or CYP3A4/3A5 inducers (e.g., rifampicin, St. John’s wort). These enzymes affect how drugs are processed in the body.
  • Needing a routine biliary stent exchange (regularly changing a tube placed in the bile duct).
  • Having an altered anatomy or a biliodigestive anastomosis (surgical connections that change the normal flow of bile and the digestive tract).
  • Having chronic pancreatitis as defined by the M‑ANNHEIM criteria (long‑term inflammation of the pancreas using specific rules).
  • Having active pancreatitis (current inflammation of the pancreas).
  • Having sepsis (a severe infection throughout the body) or being classified as ASA IV (very high surgical risk).
  • Having any reason you cannot take tacrolimus or diclofenac, such as an allergy, a high potassium level (>5 mmol/L), or very low kidney function (eGFR < 30 ml/min, a measure of how well the kidneys filter blood).
  • Being pregnant or breastfeeding.
  • Currently using tacrolimus or ciclosporin (other strong immune‑suppressing medicines).
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Verified sites

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  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

Tacrolimus is given as an intravenous infusion that is administered over 30 to 60 minutes just before the ERCP procedure. In this study the drug is being tested to see if a single dose can lower the chance of developing pancreatitis after the ERCP in patients who are at moderate to high risk. The medication works by suppressing certain immune responses, which may help prevent the inflammation that leads to pancreatitis. Patients receive the infusion through a vein, and the treatment is compared with a saline solution that does not contain any active drug.

What is already known about the treatment

Prograft 5 mg/ml concentrate for infusion - This medication is given as an intravenous infusion, usually over 30–60 minutes before a medical procedure. Tacrolimus is an approved immunosuppressant that is widely used to prevent organ rejection after transplants and is well documented in medical literature. In this study it is being tested to see if a single dose can lower the chance of developing pancreatitis after an ERCP exam. It works by blocking a protein called calcineurin, which reduces the activity of immune cells, and it belongs to the class of drugs known as calcineurin inhibitors (immunosuppressants).

Investigated diseases

Post‑ERCP Pancreatitis - Post‑ERCP pancreatitis is an inflammation of the pancreas that occurs after an endoscopic retrograde cholangiopancreatography (ERCP) procedure. It typically begins within a few hours after the procedure with abdominal discomfort that may spread to the back. Enzyme levels in the blood rise, reflecting irritation of the pancreatic tissue. The inflammation can expand, causing swelling and fluid buildup around the pancreas. In most cases the condition improves over several days as the pancreas calms down.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522900-26-00Protocol code2025-522900-26-00Estimated enrolment520 patientsSponsorAmsterdam UMC Stichting

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