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Clinical Trials/NCT04770857
NCT04770857
Unknown
Not Applicable

Evaluation of Post-Post-Endoscopic Retrograde Cholangiopancreaticography Pain (ERCP) as a Predictor for Post-ERCP Pancreatitis

Nicola Frei1 site in 1 country1,000 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-ERCP Acute Pancreatitis
Sponsor
Nicola Frei
Enrollment
1000
Locations
1
Primary Endpoint
Association between Pain 1 hour after ERCP
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
August 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Nicola Frei
Responsible Party
Sponsor Investigator
Principal Investigator

Nicola Frei

MD

Cantonal Hospital of St. Gallen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Association between Pain 1 hour after ERCP

Time Frame: 1 hour

Secondary Outcomes

  • Predictive value of VAS for PEP Predictive value of VAS for PEP(1 hour)
  • Association between VAS level and severity of PEP(1 hour)

Study Sites (1)

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