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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-ERCP Acute Pancreatitis
• Intervention / Treatment: Other: Visual analogue scale

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Nicola Fabian Frei, MD; Phone Number: +41 71 494 99 68; Email: nicolafabian.frei@kssg.ch

Study Locations

• Switzerland
  • Sankt Gallen, Switzerland, 9007
    • Kantonsspital Sankt Gallen
    • Contact: Nicola Fabian Frei, MD; Phone Number: +41 71 494 99 68; Email: nicolafabian.frei@kssg.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for ERCP for any reason at the study center will be asked for participation.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Association between Pain 1 hour after ERCP	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Predictive value of VAS for PEP Predictive value of VAS for PEP	1 hour
Association between VAS level and severity of PEP	1 hour

Collaborators and Investigators

• Sponsor: Nicola Frei

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: CTU 19/036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No