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

NCT05267379 | Recruiting

• 1 other identifier: 108224
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

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)

  1 month

Secondary Outcomes (3)

• Diclofenac levels

  2 hours

• Correlation diclofenac levels and NSAID metabolization gene polymorphisms

  1 month

• Genes involved in development of PEP

  1 month

Study Arms (2)

PEP patients

Patients who develop PEP

Diagnostic Test: Take blood samples

Control cohort

Patients who do not develop PEP

Diagnostic Test: Take blood samples

Interventions

Take blood samples DIAGNOSTIC_TEST

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

Control cohort; PEP patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Age ≥ 18 years
• written informed consent
• Indication to undergo an ERCP

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

RadboudUMC

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

• Erwin van Geenen, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike de Jong, MD

CONTACT

0031883207054; mike.dejong@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 4, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

NL (1)