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Recruiting NCT05267379

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

Conditions: Post-ERCP Acute Pancreatitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 700
Sponsor: Radboud University Medical Center

Location: RadboudUMC Nijmegen Gelderland

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.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years * written informed consent * Indication to undergo an ERCP Exclusion Criteria: * Pancreatic cancer * Chronic pancreatitis * Ongoing acute pancreatitis * Altered anatomy, defined as anatomical variations in which gall and/or pancreatic juices (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05267379). StuddyBuddy aggregates publicly available trial information.