RecruitingNCT05267379

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

Sponsor

Radboud University Medical Center

Enrollment

700 participants

Start Date

Mar 1, 2022

Study Type

OBSERVATIONAL

Conditions

Post-ERCP Acute Pancreatitis

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting data from patients who undergo ERCP — a procedure to examine and treat bile and pancreatic ducts — to understand why some patients develop pancreatitis (inflammation of the pancreas) afterward. Researchers want to identify genetic and drug-related factors that increase this risk. You may be eligible if: - You are 18 years or older - You are scheduled to have an ERCP procedure - You have provided written informed consent You may NOT be eligible if: - You have pancreatic cancer - You have chronic pancreatitis - You are currently experiencing acute pancreatitis - Your anatomy is altered in a way that changes how bile or pancreatic fluids drain (e.g., certain post-surgical changes) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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