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

Post-ERCP Acute Pancreatitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

This study is a hypothesis driven and hypothesis free analyses of PEP risk variants. Integrative analysis of NSAID pharmacokinetics and-genetics in PEP patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05267379
Study type Observational
Source Radboud University Medical Center
Contact Mike de Jong, MD
Phone 0031883207054
Email mike.dejong@radboudumc.nl
Status Recruiting
Phase
Start date March 1, 2022
Completion date December 1, 2025
View Details
See also
  Status Clinical Trial Phase
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Recruiting NCT02830984 - ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP N/A
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Active, not recruiting NCT04425993 - Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention N/A