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Interpretation of Transnasal Esophagoscopy Findings

NCT ID: NCT00372918

Last Updated: 2008-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Larynx Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Transnasal Esophagoscopy

Group Type OTHER

Transnasal Esophagoscopy

Intervention Type PROCEDURE

fiberoptic exam of esophagus thru nares

Interventions

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Transnasal Esophagoscopy

fiberoptic exam of esophagus thru nares

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Vanderbilt University Medical Center Department of GI Research

Principal Investigators

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Michael F Vaezi, MD PhD MS

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt ENT Clinic

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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060713

Identifier Type: -

Identifier Source: org_study_id