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

Radboud University Medical Center

Status: Enrolling

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Diagnostic Test: Take blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT05267379

108224

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

700 participants in 2 patient groups

PEP patients

Description:

Patients who develop PEP

Treatment:

Diagnostic Test: Take blood samples

Control cohort

Description:

Patients who do not develop PEP

Treatment:

Diagnostic Test: Take blood samples