An observational study in Post-ERCP Acute Pancreatitis, sponsored by Radboud University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Radboud University Medical Center · Observational
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.
This study is a hypothesis driven and hypothesis free analyses of PEP risk variants. Integrative analysis of NSAID pharmacokinetics and-genetics in PEP patients.
Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
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Patients aged 18 years or older with an indication to undergo an ERCP, without pancreatic cancer, chronic pancreatitis, altered anatomy of the upper digestive tract and an ongoing acute pancreatitis.
Exclusion Criteria:
Patients who develop PEP
Diagnostic Test: Take blood samples
Patients who do not develop PEP
Diagnostic Test: Take blood samples
Blood samples are used to check for polymorphisms in NSAID metabolization genes and to determine the diclofenac levels.
Differences in SNP's in NSAID metabolization genes
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)
Time frame: 1 month
Diclofenac levels
Detection of diclofenac levels two hours after diclofenac administration. Levels will be measured in blood samples by high-performance liquid chromatography (HPLC).
Time frame: 2 hours
Correlation diclofenac levels and NSAID metabolization gene polymorphisms
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).
Time frame: 1 month
Genes involved in development of PEP
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.
Time frame: 1 month
Plan to share: Undecided — The dataset used during this study is available from the corresponding author upon reasonable request.
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