PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms

Completed

• Conditions: Post-ERCP Acute Pancreatitis

• Registration Number: NCT05310409
• Lead Sponsor: University of Pennsylvania

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 productivity.

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. The study will compare the change of PAN-PROMISE before and after ERCP to the current standard diagnostic criteria for post-ERCP pancreatitis, the Cotton Consensus Criteria. The main limitations of the Cotton-Consensus Criteria are that it fails to capture outpatient or ambulatory morbidity, uses length of stay to define the severity of pancreatitis without accounting for local or systemic complications for pancreatitis, and it has limited sensitivity in patients with chronic symptoms such as patients with chronic pancreatitis or pancreatic adenocarcinoma. These limitations have impeded the evaluation of potential therapies to prevent post-ERCP pancreatitis. PAN-PROMISE will help capture and quantitate the morbidity related to post-ERCP pancreatitis and thus will enhance our ability to optimize outcomes following ERCP.

Study Timeline

• Study Start: 2020-09-15
• Primary Completion: 2021-08-01
• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-04-04
• Study Completion: 2023-01-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. Patients undergoing ERCP
2. Age >= 18 years old
3. Intact major papilla

Exclusion Criteria

1. Unwillingness or inability to consent for the study
2. Age < 18 years
3. Standard contraindications to ERCP
4. Intrauterine pregnancy
5. Prior hepaticojejunostomy in a patient undergoing ERCP for a bile duct indication
6. Prior pancreaticojejunostomy in a patient undergoing ERCP for a pancreatic duct indication
7. Low probability of completing the follow-up
8. Acute pancreatitis (by the Revised Atlanta criteria) in the seven days prior to ERCP.
9. Patients who do not answer at least 80% of the questions on the baseline and 48-hour follow-up survey.
10. Patients who could not be contacted via a telephone call to assess for post-ERCP complications at 48-72 hours.
11. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PROM-PEP	30 days	will capture the work abseentism and loss of productivity using the Work-Productivity and Activity Impairment Questionnaire and will express in in 2021 US Dollars.
Post-ERCP Pancreatitis	7 days after ERCP	will define post-ERCP pancreatitis using the Cotton Consensus Criteria with a 3 physician adjudication committee.

Secondary Outcome Measures

Name	Time	Method
Direct Health Care Costs	30 days	will capture the direct healthcare costs using the Medicare Reimbursement data and express it in 2021 US Dollars.

Trial Locations

Locations (2)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States