NCT07781722 Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis
| NCT ID | NCT07781722 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Post-ERCP Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 520 participants |
| Start Date | 2026-10-16 |
| Primary Completion | 2028-09-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 520 participants in total. It began in 2026-10-16 with a primary completion date of 2028-09-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07781722 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-ERCP Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07781722 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07781722 currently recruiting?
Yes, NCT07781722 is actively recruiting participants. Contact the research team at m.witteman1@amsterdamumc.nl for enrollment information.
Where is the NCT07781722 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT07781722 clinical trial?
NCT07781722 is sponsored by Amsterdam UMC, location VUmc. The trial plans to enroll 520 participants.