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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05267379
Other study ID # 108224
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date December 1, 2025

Study information

Verified date February 2024
Source Radboud University Medical Center
Contact Mike de Jong, MD
Phone 0031883207054
Email mike.dejong@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Take blood samples
Blood samples are used to check for polymorphisms in NSAID metabolization genes and to determine the diclofenac levels.

Locations

Country Name City State
Netherlands RadboudUMC Nijmegen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 1 month
Secondary Diclofenac levels Detection of diclofenac levels two hours after diclofenac administration. Levels will be measured in blood samples by high-performance liquid chromatography (HPLC). 2 hours
Secondary 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). 1 month
Secondary 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. 1 month
See also
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