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PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms

Sponsor
University of Pennsylvania (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05310409
Collaborator
(none)
700
Enrollment
2
Locations
32.5
Anticipated Duration (Months)
350
Patients Per Site
10.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-Reported Outcome Measure, To Detect and Risk-Stratify Post-ERCP Pancreatitis
    Actual Study Start Date :
    Sep 15, 2020
    Actual Primary Completion Date :
    Aug 1, 2021
    Anticipated Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Post-ERCP Pancreatitis [7 days after ERCP]

      will define post-ERCP pancreatitis using the Cotton Consensus Criteria with a 3 physician adjudication committee.

    2. 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.

    Secondary Outcome Measures

    1. Direct Health Care Costs [30 days]

      will capture the direct healthcare costs using the Medicare Reimbursement data and express it in 2021 US Dollars.

    Other Outcome Measures

    1. Quality of Life Assessment [30 days]

      will capture changes in Quality of Life using the SF-12 instrument.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143
    2 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    • Principal Investigator: Michael L Kochman, MD, University of Pennsylvania
    • Principal Investigator: Mustafa Arain, MD, University of California, San Francisco
    • Principal Investigator: Nikhil R Thiruvengadam, MD, Loma Linda University School of Medicine.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT05310409
    Other Study ID Numbers:
    • PAN-PROMISE
    First Posted:
    Apr 4, 2022
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatitis

    Study Results

    No Results Posted as of Jul 27, 2022