Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07781722 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Tacrolimus as Prophylaxis of Post-ERCP Pancreatitis

Study acronym: TacroProph
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07781722
Lead Sponsor Amsterdam UMC, location VUmc
Conditions
(from sponsor)
Post-ERCP Pancreatitis
Enrollment 520 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov