Status:
COMPLETED
PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms
Lead Sponsor:
University of Pennsylvania
Conditions:
Post-ERCP Acute Pancreatitis
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to use a validated patient-reported outcome measure to evaluate how many patients have symptoms of pancreatitis after ERCP and how it correlates with their quality of life and...
Detailed Description
This project will measure the impact of a recently validated patient-reported outcome measure for acute pancreatitis, PAN-PROMISE, to detect post-ERCP pancreatitis symptoms and capture its morbidity. ...
Eligibility Criteria
Inclusion
- Patients undergoing ERCP
- Age \>= 18 years old
- Intact major papilla
Exclusion
- Unwillingness or inability to consent for the study
- Age \< 18 years
- Standard contraindications to ERCP
- Intrauterine pregnancy
- Prior hepaticojejunostomy in a patient undergoing ERCP for a bile duct indication
- Prior pancreaticojejunostomy in a patient undergoing ERCP for a pancreatic duct indication
- Low probability of completing the follow-up
- Acute pancreatitis (by the Revised Atlanta criteria) in the seven days prior to ERCP.
- Patients who do not answer at least 80% of the questions on the baseline and 48-hour follow-up survey.
- Patients who could not be contacted via a telephone call to assess for post-ERCP complications at 48-72 hours.
- Patients who speak a language other than English, Spanish, Bulgarian, Mandarin, English, French, German, Greek, Hungarian, Italian, Korean, Polish, Portuguese, Romanian, Russian, Turkish, Ukrainian, or Hindi (as the PAN-PROMISE has only been translated and validated in these languages.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT05310409
Start Date
September 15 2020
End Date
January 1 2023
Last Update
July 5 2023
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104