Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03063398 |
| Other study ID # |
STUDY19080096 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 21, 2017 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
