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Recruiting NCT07781722

Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis

Conditions: Post-ERCP Pancreatitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 520
Sponsor: Amsterdam UMC, location VUmc

Location: Amsterdam UMC, Location VUmc Amsterdam

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07781722). StuddyBuddy aggregates publicly available trial information.