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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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This study is a hypothesis driven and hypothesis free analyses of PEP risk variants. Integrative analysis of NSAID pharmacokinetics and-genetics in PEP patients.

Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PEP patients

Patients who develop PEP

Take blood samples

Intervention Type DIAGNOSTIC_TEST

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

Control cohort

Patients who do not develop PEP

Take blood samples

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Take blood samples

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No