An observational study in Acute Pancreatitis, sponsored by Ohio State University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Ohio State University · Observational
This study is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an AP attack.
This study is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an AP attack. A blood sample will be collected for measurement of nutritional markers and a fecal sample for elastase-1, and data regarding demographics, etiology, history of previous pancreatitis episodes, and their hospital course (imaging findings, interventions, length of stay, intensive care admission, and severity based on the Revised Atlanta Classification) will be obtained from medical records at hospital discharge. Subsequently, each subject will be prospectively followed at 3 months and 1 year after hospital discharge. In each follow-up, he/she will be asked to answer a questionnaire focusing on symptoms of exocrine pancreatic insufficiency and quality of life. Furthermore, blood and stool samples will be collected at the 3 and 12-month follow up for measurement of nutritional markers and fecal elastase-1 levels.
Based on available literature and our own data, we hypothesize that a significant fraction of AP patients develop EPI that may persist up to 1 year after the discharge, and result in nutritional deficiencies and impaired QOL. This study will help to clarify the incidence, natural history and duration of EPI, as well as identify subgroups of patients at high risk of EPI after AP. It will serve as the basis for the design of future randomized controlled trials of pancreatic enzyme replacement following AP. This is a novel proposal by an investigator with extensive experience and a well-established record in AP research from an internationally known pancreas center of excellence. The methodological strength of our proposal lies on its prospective nature, the 1-year follow up with serial assessments of EPI, nutritional status and QOL, and the detailed phenotypical characterization of the AP patient cohort.
Primary endpoints
Secondary endpoints
759 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's enrollment of 196 is close to the median of 179 across 282 observational studies indexed under Pancreatitis.
Browse Pancreatitis studies →Ohio State University is the lead sponsor of 661 studies on the registry; 148 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
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Men and women, at least 18 years of age, admitted at the University of Pittsburgh Medical Center with an AP attack defined as the presence of 2 or more of the following criteria:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Men and women, at least 18 years of age, admitted at the University of Pittsburgh Medical Center with an AP attack defined as the presence of 2 or more of the following criteria:
Exclusion Criteria:
Such patients will be followed and assessed for the development of Exocrine Pancreatic Insufficiency. 'No intervention, this is an observational study.
Diagnostic Test: No intervention, this is an observational study
Assessment for exocrine pancreatic insufficiency
Exocrine pancreatic insufficiency at 12 months
Fecal elastase-1 levels EPI below 200 mcg/g stool,
Time frame: 12 months
Plan to share: Undecided — In the future, the data may be shared with other entities. If so, the research data/documents will be coded and subject identifiers removed prior to access by the external persons.
Ran from Jun 2017 to primary completion in Feb 2023, 67 months.
Of 120 non-industry observational studies under Pancreatitis, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 127. This study's 67 months is above that.
Counting every sponsor, half of 125 studies reached it within 42 months; a quarter within 20 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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