Interpretation of Transnasal Esophagoscopy Findings (TNE)
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|ClinicalTrials.gov Identifier: NCT00372918|
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : June 5, 2008
|Condition or disease||Intervention/treatment||Phase|
|Larynx Disease||Procedure: Transnasal Esophagoscopy||Phase 4|
Throat symptoms are common complaints for many patients. Some symptoms are thought to be attributable to laryngopharyngeal reflux (i.e. the reflux of stomach acid to the level of the larynx). It is unclear what role laryngopharyngeal reflux (LPR) has in producing throat symptoms and its relationship to laryngeal pathology. LPR may be more carefully diagnosed if knowledge could be obtained regarding the presence of esophageal manifestations of reflux of stomach acid. Although LPR may occur in the absence of esophageal manifestations, the presence may make this diagnosis more probable. If so, therapy can be more carefully directed.
Using a flexible endoscope, otolaryngologists perform transnasal flexible laryngoscopy. This requires only topical anesthesia and occurs in the clinic setting. The small caliber transnasal esophagoscope was developed in recent years and is performed in a similar manner. It can provide key information regarding esophageal pathology. This obviates the need for administration of anesthesia (i.e. other than the topical, non-sedating agent). Transnasal flexible laryngoscopy is considered to be the standard of care for evaluation of the larynx. Transnasal esophagoscopy is an extension of this standard of care.
There are a number of studies demonstrating the safety and utility of transnasal esophagoscopy in humans. Typically these studies are composed of retrospectively on a select group of patients. Additionally the TNE findings are reviewed by one medical discipline. This study will be the first prospective analysis of TNE in which the findings will be reviewed in a multidisciplinary manner (i.e. otolaryngologists and gastroenterologist). Also, the population involved will be more general than previous studies, representing a myriad of throat symptoms.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Interdisciplinary Interpretation of Transnasal Esophagoscopy Findings|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
Procedure: Transnasal Esophagoscopy
fiberoptic exam of esophagus thru nares
- The intraobserver variability of Transnasal Esophagoscopy [ Time Frame: one week apart ]
- The interdisciplinary variability of Transnasal Esophagoscopy [ Time Frame: one week apaart ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372918
|United States, Tennessee|
|Vanderbilt ENT Clinic|
|Nashville, Tennessee, United States, 37232-5280|
|Principal Investigator:||Michael F Vaezi, MD PhD MS||Vanderbilt University|