Understanding genetic and pharmacokinetic factors in post-ERCP pancreatitis
An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
This study is trying to find out how genetic factors and how the body processes medications affect the risk of developing pancreatitis after a specific procedure called ERCP.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT05267379 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the genetic and pharmacokinetic factors that contribute to the risk of post-ERCP pancreatitis (PEP). It will involve collecting blood samples from patients who are scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP) to analyze potential risk variants. The study seeks to understand why some patients experience PEP despite preventive measures, such as the administration of rectal NSAIDs. By integrating pharmacokinetic data with genetic information, the research hopes to uncover underlying mechanisms that could inform better prevention strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled to undergo an ERCP.
Not a fit: Patients with pancreatic cancer, chronic pancreatitis, ongoing acute pancreatitis, or altered anatomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for post-ERCP pancreatitis, reducing morbidity and healthcare costs.
How similar studies have performed: While studies on post-ERCP pancreatitis exist, this integrative approach focusing on genetic and pharmacokinetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nijmegen, Gelderland
- RadboudUMC — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Erwin van Geenen, MD, PhD — Radboud University Medical Center
- Study coordinator: Mike de Jong, MD
- Email: mike.dejong@radboudumc.nl
- Phone: 0031883207054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.