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RECRUITING
NCT05267379

An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death. The pathophysiology of PEP and the underpinnings of the preventive effect of rectal NSAID (RN) is poorly understood. Guidelines advise to take preventive measures with a single dose of 100mg RN, peri-ERCP. While NSAID administration reduces the risk with 40%, PEP still occurs after ERCP. In addition, patients with a PEP history have a higher risk to develop recurrence after a subsequent ERCP. This might suggest that an underlying genetic risk may contribute to increasing the incidence of PEP in some patients.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

700

Start Date

2022-03-01

Completion Date

2027-12-01

Last Updated

2025-04-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Take blood samples

Blood samples are used to check for polymorphisms in NSAID metabolization genes and to determine the diclofenac levels.

Locations (1)

RadboudUMC

Nijmegen, Gelderland, Netherlands