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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

written informed consent

Indication to undergo an ERCP

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Take blood samples

    Diagnostic test

    Blood samples are used to check for polymorphisms in NSAID metabolization genes and to determine the diclofenac levels.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: PEP patients1 intervention
Group B: Control cohort1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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