Exploratory Study of Potential Pulmonary Aspiration Markers From Bronchoalveolar Lavage Fluid (Pepsin)
The purpose of this study is to learn if chemicals from the mouth or stomach can be found in the lungs. This may suggest a process called aspiration. This study may help us understand if aspiration plays a role in different lung diseases.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Exploratory Study of Potential Pulmonary Aspiration Markers From Bronchoalveolar Lavage Fluid"|
BALF specimens will be collected by the MCF Biospecimen Facility at the time of the bronchoscopy. A minimum of 5 mL will be collected. Specimen processing will include centrifugation to separate the cell pellet from the supernatant. The supernatant will be stored in 2 mL cryovials, and stored at -70°C until time of testing for the pepsin-ELISA. Storage will allow retesting at another date if the assay is modified or if another substance of interest arises in the course of the study that requires re-testing of the specimens. The clinical sample will also be tested through the Mayo Clinic medical laboratory for bilirubin, pepsinogen, amylase, and lipase.
|Study Start Date:||January 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
This study is a single center, prospective, observational study of determining pepsin levels in BALF samples obtained from consecutive bronchoscopies at the Mayo Clinic Jacksonville. It is inherently an exploratory pilot study to confirm whether pepsin in BAL can act as a marker of gastric to pulmonary aspiration and whether specific association to pulmonary pathologies can be identified.
As an overview, all patients who are undergoing a bronchoscopy for clinical indications will be screened for potential participation in the study by obtaining BALF samples during the procedure for laboratory analyses. The BALF will then be tested for pepsin at the Thoracic Diseases Research Unit (Mayo Clinic Rochester) using a commercially available ELISA kit, and the ancillary markers will be analyzed per the clinical laboratory. Internal controls will be defined as normals when subjects have no lung dysfunction, no respiratory symptoms, and no lung parenchymal infiltrates on chest radiographs.
The primary aims of this project parallels the short-term hypotheses stated above:
- Confirm pepsin can be detected and quantitated in BALF obtained during a routine bronchoscopy.
- Identify specific pulmonary pathologies that are more often associated with increased pepsin BAL levels.
- Identify a normal range of pepsin in BALF in control normals.
- Identify any correlation of pepsin BAL levels with reflux, swallow, or respiratory symptoms (standardized questionnaires).
- Identify any correlation between pepsin BAL levels and lung function test or radiographic abnormalities.
Secondary aims of the study will include exploratory analyses of lesser defined potential aspiration markers including bilirubin, lipase, amylase, and pepsinogen. Analyses of these markers will parallel the analyses performed for pepsin.
The focus of the study is to:
- definitively identify whether pulmonary aspiration is occurring;
- quantitate the burden of aspiration that is occurring (i.e., dose);
- localize from where aspiration is occurring (e.g., gastric, duodenal, biliary, oropharyngeal, nasal);
- identify what is specifically being aspirated (e.g., acid, exogenous oils, bacteria, gastric contents, bile, gastric enzymes, pancreatic enzymes).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915941
|United States, Florida|
|Jacksonville, Florida, United States, 32224|