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Tacrolimus as prophylaxis of post-ERCP pancreatitis
EU CTIS ID: 2025-522900-26-00
What this study is testing
To determine whether a single intravenous dose of tacrolimus infused over 30-60 minutes and completed before ERCP reduces the incidence of post-ERCP pancreatitis compared with placebo in moderate- to high-risk patients.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18+ years
- Indication for ERCP
- Ability to provide written informed consent
You likely can't join if
- Previous sphincterotomy or sphincteroplasty
- 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)
- Routine biliary stent exchange
- Altered anatomy or biliodigestive anastomosis
- Chronic pancreatitis according to the M-ANNHEIM criteria
- Active pancreatitis
See the full eligibility criteria
- Age 18+ years
- Indication for ERCP
- Ability to provide written informed consent
- Previous sphincterotomy or sphincteroplasty
- 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.