An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-ERCP Acute Pancreatitis
- Sponsor
- Radboud University Medical Center
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Differences in SNP's in NSAID metabolization genes
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Differences in SNP's in NSAID metabolization genes
Time Frame: 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 Outcomes
- Diclofenac levels(2 hours)
- Correlation diclofenac levels and NSAID metabolization gene polymorphisms(1 month)
- Genes involved in development of PEP(1 month)