Tacrolimus as prophylaxis of post-ERCP pancreatitis: a DPSG (Dutch Pancreatitis Study Group) multicenter, double-blind, randomized, placebo-controlled study.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522900-26-00

Enrollment

520

Registered

2026-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-ERCP Pancreatitis

Brief summary

Occurrence of post-ERCP pancreatitis (PEP) within 48 hours after ERCP, defined according to the revised Atlanta criteria: ≥ 2 of the following: (a) characteristic abdominal pain; (b) serum amylase or lipase > 3× upper limit of normal; (c) imaging findings consistent with pancreatitis.

Detailed description

Occurrence of PEP within 30 days after ERCP., Severity of PEP according to the revised Atlanta classification, ERCP-related complications: bleeding, perforation, fever/cholangitis, cholecystitis., Adverse events (AEs), serious adverse events (SAEs), and adverse reactions., Length of hospital or ICU stay; readmissions and additional procedures., Quality of life (EQ-5D-5L) and QALYs up to 12 weeks., Healthcare consumption costs and societal costs as measured with IMCQ and IPCQ questionnaires up to 12 weeks., Tacrolimus whole-blood concentrations (pharmacokinetic cohort, first 40 subjects).

Interventions

DRUGPrograft 5 mg/ml concentraat voor oplossing voor infusie

DRUGsodium chloride 0.9% solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of post-ERCP pancreatitis (PEP) within 48 hours after ERCP, defined according to the revised Atlanta criteria: ≥ 2 of the following: (a) characteristic abdominal pain; (b) serum amylase or lipase > 3× upper limit of normal; (c) imaging findings consistent with pancreatitis.	—

Secondary

Measure	Time frame
Occurrence of PEP within 30 days after ERCP., Severity of PEP according to the revised Atlanta classification, ERCP-related complications: bleeding, perforation, fever/cholangitis, cholecystitis., Adverse events (AEs), serious adverse events (SAEs), and adverse reactions., Length of hospital or ICU stay; readmissions and additional procedures., Quality of life (EQ-5D-5L) and QALYs up to 12 weeks., Healthcare consumption costs and societal costs as measured with IMCQ and IPCQ questionnaires up to 12 weeks., Tacrolimus whole-blood concentrations (pharmacokinetic cohort, first 40 subjects).	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 20, 2026