An observational study in Post-ERCP Acute Pancreatitis, sponsored by University of Pennsylvania. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-05.
Sponsored by University of Pennsylvania · Observational
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.
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.
University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
We are enrolling patients who are undergoing ERCP at our two centers.
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Exclusion Criteria:
Post-ERCP Pancreatitis
will define post-ERCP pancreatitis using the Cotton Consensus Criteria with a 3 physician adjudication committee.
Time frame: 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.
Time frame: 30 days
Direct Health Care Costs
will capture the direct healthcare costs using the Medicare Reimbursement data and express it in 2021 US Dollars.
Time frame: 30 days
Quality of Life Assessment
will capture changes in Quality of Life using the SF-12 instrument.
Time frame: 30 days
Plan to share: No
Ran from Sep 2020 to primary completion in Aug 2021, 10 months.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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