Interpretation of Transnasal Esophagoscopy Findings

Larynx Disease Clinical Trial

— TNE  

Official title:

An Interdisciplinary Interpretation of Transnasal Esophagoscopy Findings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372918
• Other study ID #: 060713
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2006
• Last updated: June 4, 2008
• Start date: September 2006
• Est. completion date: April 2008

Study information

• Verified date: June 2008
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Study participants include persons 18 years and older

• Patients presenting to the Vanderbilt Voice Center and complaining of throat symptoms. These include hoarseness, throat clearing/pain/burning, heartburn, globus sensation, and acidic/sour taste.

• New and return patients will be included.

Exclusion criteria:

• Participants who are unwilling to undergo the study

• Patients who have had prior esophagoscopy

• Those who do not sign the consent

• Pregnant women.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Laryngeal Diseases
• Larynx Disease

Intervention

Procedure:
• Transnasal Esophagoscopy
fiberoptic exam of esophagus thru nares

Locations

Country	Name	City	State
United States	Vanderbilt ENT Clinic	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intraobserver variability of Transnasal Esophagoscopy		one week apart	No
Primary	The interdisciplinary variability of Transnasal Esophagoscopy		one week apaart	No