NCT03063398

Post Acute Pancreatitis Pancreatic Exocrine Insufficiency

PAPPEI: Post Acute Pancreatitis Pancreatic Exocrine Insufficiency

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 196 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 * Measure the incidence of exocrine pancreatic insufficiency at 12 months after an attack of AP. Secondary endpoints * Identify subgroups of patients at risk for EPI at 12 months after an attack of AP based on severity classification, etiology, and demographics. * Measure the incidence of transient (present at 3 but no at 12 months) and persistent (present both at 3 and 12 months after AP) exocrine pancreatic insufficiency following an AP attack. * Measure the incidence of nutritional deficiencies, and impaired quality of life at 3 and 12 months from an attack of AP. * Assess whether EPI is associated with nutritional deficiencies or impaired quality of life at 3 and 12 months from an AP attack.

Conditions

• Acute Pancreatitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	No intervention, this is an observational study	Assessment for exocrine pancreatic insufficiency

Timeline

• Start date: 2017-06-21
• Primary completion: 2023-02-01
• Completion: 2024-06-30
• First posted: 2017-02-24
• Last updated: 2024-07-16

Locations

3 sites across 1 country: United States