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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05310409
Recruitment Status : Active, not recruiting
First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Post-ERCP Acute Pancreatitis

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. We 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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 : September 15, 2020
Actual Primary Completion Date : August 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis




Primary Outcome Measures :
  1. Post-ERCP Pancreatitis [ Time Frame: 7 days after ERCP ]
    We will define post-ERCP pancreatitis using the Cotton Consensus Criteria with a 3 physician adjudication committee.

  2. PROM-PEP [ Time Frame: 30 days ]
    We 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 [ Time Frame: 30 days ]
    We 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 [ Time Frame: 30 days ]
    We will capture changes in Quality of Life using the SF-12 instrument.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
We are enrolling patients who are undergoing ERCP at our two centers.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05310409


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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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.
Publications:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT05310409    
Other Study ID Numbers: PAN-PROMISE
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases