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