PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms (PAN-PROMISE)

July 3, 2023 updated by: University of Pennsylvania

A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-Reported Outcome Measure, To Detect and Risk-Stratify Post-ERCP Pancreatitis

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

We are enrolling patients who are undergoing ERCP at our two centers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-ERCP Pancreatitis
Time Frame: 7 days after ERCP
will define post-ERCP pancreatitis using the Cotton Consensus Criteria with a 3 physician adjudication committee.
7 days after ERCP
PROM-PEP
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct Health Care Costs
Time Frame: 30 days
will capture the direct healthcare costs using the Medicare Reimbursement data and express it in 2021 US Dollars.
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Assessment
Time Frame: 30 days
will capture changes in Quality of Life using the SF-12 instrument.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN-PROMISE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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