Post-ERCP Acute Pancreatitis
Conditions
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.
Detailed description
This study is a hypothesis driven and hypothesis free analyses of PEP risk variants. Integrative analysis of NSAID pharmacokinetics and-genetics in PEP patients.
Interventions
DIAGNOSTIC_TESTTake blood samples
Blood samples are used to check for polymorphisms in NSAID metabolization genes and to determine the diclofenac levels.
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in SNP's in NSAID metabolization genes | 1 month | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diclofenac levels | 2 hours | Detection of diclofenac levels two hours after diclofenac administration. Levels will be measured in blood samples by high-performance liquid chromatography (HPLC). |
| Correlation diclofenac levels and NSAID metabolization gene polymorphisms | 1 month | 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). |
| Genes involved in development of PEP | 1 month | 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. |
Countries
Netherlands
Contacts
CONTACTMike de Jong, MD
PRINCIPAL_INVESTIGATORErwin van Geenen, MD, PhD
Radboud University Medical Center
Outcome results
None listed