Interpretation of Transnasal Esophagoscopy Findings

Phase 4

Completed

• Conditions: Larynx Disease
• Interventions: Procedure: Transnasal Esophagoscopy

• Registration Number: NCT00372918
• Lead Sponsor: Vanderbilt University

Brief Summary

The purpose of this study is to determine the prevalence of esophageal pathology in patients with voice disorders. In addition, , the intra- and interdisciplinary variability regarding the identification of esophageal pathology will be analyzed in this study.

Detailed Description

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-07
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-04
• Last Update Posted: 2008-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Transnasal Esophagoscopy	Transnasal Esophagoscopy

Primary Outcome Measures

Name	Time	Method
The intraobserver variability of Transnasal Esophagoscopy	one week apart
The interdisciplinary variability of Transnasal Esophagoscopy	one week apaart

Trial Locations

Locations (1)

Vanderbilt ENT Clinic; 🇺🇸 Nashville, Tennessee, United States