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Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis (PEP-PREPARE)

N

Nicola Frei

Status

Unknown

Conditions

Post-ERCP Acute Pancreatitis

Treatments

Other: Visual analogue scale

Study type

Observational

Funder types

Other

Identifiers

NCT04770857
CTU 19/036

Details and patient eligibility

About

Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from < 2% up to 40%.

Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP.

This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age >18 years
  • Scheduled for ERCP for any reason

Exclusion criteria

  • Absence of consent
  • Language barrier
  • No endoscopic advance to the papilla vateri
  • Active pancreatitis at the time of the procedure
  • Mental disability

Trial contacts and locations

1

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Central trial contact

Nicola Fabian Frei, MD

Data sourced from clinicaltrials.gov

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