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NCT Number: NCT05267379

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

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.

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Key information

Conditions

Post-ERCP Acute Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Take blood samples

Diagnostic Test

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

Primary outcomes

  1. Differences in SNP's in NSAID metabolization genes

    Time frame: 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 outcomes

  1. Diclofenac levels

    Time frame: 2 hours

    Detection of diclofenac levels two hours after diclofenac administration. Levels will be measured in blood samples by high-performance liquid chromatography (HPLC).

  2. Correlation diclofenac levels and NSAID metabolization gene polymorphisms

    Time frame: 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).

  3. Genes involved in development of PEP

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mike de Jong, MD

CONTACT

[email protected]

0031883207054

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: G-PEP

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2022
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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