NCT05267379 An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
| NCT ID | NCT05267379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Post-ERCP Acute Pancreatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2022-03-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Erwin van Geenen, MD, PhD
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT05267379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-ERCP Acute Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05267379 currently recruiting?
Yes, NCT05267379 is actively recruiting participants. Contact the research team at mike.dejong@radboudumc.nl for enrollment information.
Where is the NCT05267379 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT05267379 clinical trial?
NCT05267379 is sponsored by Radboud University Medical Center. The principal investigator is Erwin van Geenen, MD, PhD at Radboud University Medical Center. The trial plans to enroll 700 participants.