Novel Breath Test to Detect Early Stage Chronic Pancreatitis
The goal of this study is to evaluate the feasibility of using a non-invasive, non-radioactive Pancreatic Breath Test (PBT) as a diagnostic tool to detect early stages of chronic pancreatitis (CP). If successful, this method could have important advantages over existing diagnostic tests for detecting early stage CP. This diagnostic breath test may have a clinical impact if it leads to early detection of CP and intervention to mitigate disease progression.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Phase 1 Study of the Pancreatic Breath Test to Detect Early Stage Chronic Pancreatitis Utilizing the Secretin Stimulation Test|
- Output of C13-CO2 [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]Change in C13-CO2 compared to baseline values at 5, 10, and 15 minutes
Biospecimen Retention: Samples Without DNA
|Study Start Date:||May 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Mild to Moderate CP
Subjects must have a history compatible with chronic pancreatitis.
Subjects must be in good health of greater than 18 years of age.
Disorders of the pancreas affect more than one million persons in this country with nearly $3 billion in health care costs. The incidence rate of chronic pancreatitis (CP) is rapidly increasing and may be related to expanded alcohol abuse. Advanced CP can be easily detected by imaging techniques. However, mild to moderate CP presents a more difficult challenge for clinicians. Imaging techniques fail to recognize less advanced CP cases about 40% of the time. The gold standard for monitoring early stage CP is the secretin stimulation test. However, the secretin stimulation test is only done in a few US centers.
The investigators have developed the Pancreatic Breath Test (PBT) as an alternative to the secretin stimulation test. The breath test uses a tracer dose of sodium 13C-bicarbonate to detect the amount of bicarbonate released after stimulation of the pancreatitis by a meal (liquid Ensure). A normal pancreas releases unlabeled bicarbonate upon stimulation, decreasing the ratio of 13C/12C of exhaled carbon dioxide. This ratio will change much less in a diseased pancreas.
A case-control study in 25 mild to moderate CP patients and 25 healthy controls will be utilized to show feasibility of the new breath test.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184573
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Phillip P Toskes, MD||University of Florida at Gainesville|
|Principal Investigator:||David A Wagner, PhD||Metabolic Solutions Inc.|