RecruitingNCT05267379

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


Sponsor

Radboud University Medical Center

Enrollment

700 participants

Start Date

Mar 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria4

  • 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.

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Interventions

DIAGNOSTIC_TESTTake blood samples

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


Locations(1)

RadboudUMC

Nijmegen, Gelderland, Netherlands

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NCT05267379


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