PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post-ERCP Acute Pancreatitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing ERCP Age >= 18 years old Intact major papilla Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP Pancreatitis | will define post-ERCP pancreatitis using the Cotton Consensus Criteria with a 3 physician adjudication committee. | 7 days after ERCP | 
| PROM-PEP | 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 | will capture the direct healthcare costs using the Medicare Reimbursement data and express it in 2021 US Dollars. | 30 days |