Understanding genetic and pharmacokinetic factors in post-ERCP pancreatitis
Official title: An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Run by Radboud University Medical Center · NCT05267379 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT05267379 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are scheduled to undergo an ERCP.
✕Probably not a fit
Patients with pancreatic cancer, chronic pancreatitis, ongoing acute pancreatitis, or altered anatomy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While studies on post-ERCP pancreatitis exist, this integrative approach focusing on genetic and pharmacokinetic factors is relatively novel.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Can a rectal NSAID alone prevent pancreatitis after ERCP instead of also placing a pancreatic duct stent?
This trial will see if giving a rectal NSAID by itself prevents pancreatitis after ERCP in high-risk adults as well as giving both a rectal NSAID and a pancreatic duct stent.
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Using intravenous fluids to prevent pancreatitis after ERCP procedures
This study tests if different types of intravenous fluids can help prevent pancreatitis in patients undergoing ERCP procedures.
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Using Tacrolimus and Indomethacin to Prevent Pancreatitis After ERCP
This study is testing if taking a medication called tacrolimus before a procedure to remove bile duct stones can help prevent pancreatitis in patients.
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Short-stay aggressive hydration to prevent post-ERCP pancreatitis
This trial tests whether a short, high-volume IV hydration with Lactated Ringer's plus a rectal indomethacin can prevent post-ERCP pancreatitis in adults undergoing ERCP.
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Low-dose versus standard-dose indomethacin to prevent pancreatitis after ERCP
This test sees if a lower rectal dose of indomethacin prevents pancreatitis as well as the standard 100 mg dose in adults undergoing ERCP.
-
Comparing early and late pancreatic stent placement to prevent post-ERCP pancreatitis
This study is testing whether placing a pancreatic stent right after a procedure or later can help prevent pancreatitis in patients who have a difficult time with bile duct access.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.