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Completed

NCT Number: NCT00372918

Interpretation of Transnasal Esophagoscopy Findings

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt ENT Clinic

Nashville, Tennessee, 37232-5280, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transnasal Esophagoscopy

Procedure

fiberoptic exam of esophagus thru nares

Primary outcomes

  1. The intraobserver variability of Transnasal Esophagoscopy

    Time frame: one week apart

  2. The interdisciplinary variability of Transnasal Esophagoscopy

    Time frame: one week apaart

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

An Interdisciplinary Interpretation of Transnasal Esophagoscopy Findings

Acronym: TNE

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 7, 2006
Registry last updated
Jun 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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