Tacrolimus as prophylaxis of post-ERCP pancreatitis

INTERVENTION: Product Name: Prograft 5 mg/ml concentraat voor oplossing voor infusie, Product Code:PRD324884, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: sodium chloride 0.9% solution for infusion, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A CONDITION: Post‐ERCP Pancreatitis Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] SECONDARY OUTCOME: Secondary end point(s):Adverse events (AEs), serious adverse events (SAEs), and adverse reactions. Secondary end point(s):ERCP‐related complications: bleeding, perforation, fever/cholangitis, cholecystitis. Secondary end point(s):Healthcare consumption costs and societal costs as measured with IMCQ and IPCQ questionnaires up to 12 weeks. Secondary end point(s):Length of hospital or ICU stay; readmissions and additional procedures. Secondary end point(s):Occurrence of PEP within 30 days after ERCP. Secondary end point(s):Quality of life (EQ‐5D‐5L) and QALYs up to 12 weeks. Secondary end point(s):Severity of PEP according to the revised Atlanta classification Secondary end point(s):Tacrolimus whole‐blood concentrations (pharmacokinetic cohort, first 40 subjects). INCLUSION CRITERIA: Age 18+ years, Indication for ERCP, Ability to provide written informed consent