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

Recruiting

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Diagnostic Test: Take blood samples

• Registration Number: NCT05267379
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-23
• Study Start: 2022-03-01
• Study First Posted: 2022-03-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control cohort	Take blood samples	Patients who do not develop PEP
PEP patients	Take blood samples	Patients who develop PEP

Primary Outcome Measures

Name	Time	Method
Differences in SNP's in NSAID metabolization genes	1 month	Analyzing differences in polymorphisms in NSAID metabolization genes between PEP patients and control patients using Taqman assay. DNA will be isolated from blood samples and analyzed for SNP's of biotransformation enzymes such as UDP-Glucuronosyltransferase-2B7 (UGT2B7) and CYP2C9. This will be done using polymerase chain reaction (PCR) with fluorescent probes specific for a SNP (Taqman assay)

Secondary Outcome Measures

Name	Time	Method
Diclofenac levels	2 hours	Detection of diclofenac levels two hours after diclofenac administration. Levels will be measured in blood samples by high-performance liquid chromatography (HPLC).
Correlation diclofenac levels and NSAID metabolization gene polymorphisms	1 month	To investigate whether there is a correlation between diclofenac levels and NSAID metabolism gene polymorphisms. Using an independent t-test, the investigators will try to find a significant correlation between the diclofenac levels and a difference in single nucleotide polymorphism (SNP).
Genes involved in development of PEP	1 month	To investigate whether the known genes involved in developing acute pancreatitis also are involved in developing PEP. DNA isolated from the blood samples will be analyzed by Miniseq-technique.

Trial Locations

Locations (1)

RadboudUMC; 🇳🇱 Nijmegen, Gelderland, Netherlands