TNE: Interpretation of Transnasal Esophagoscopy Findings

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT00372918
Collaborator
(none)
98
1
1
19
5.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transnasal Esophagoscopy
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
An Interdisciplinary Interpretation of Transnasal Esophagoscopy Findings
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Transnasal Esophagoscopy

Procedure: Transnasal Esophagoscopy
fiberoptic exam of esophagus thru nares

Outcome Measures

Primary Outcome Measures

  1. The intraobserver variability of Transnasal Esophagoscopy [one week apart]

  2. The interdisciplinary variability of Transnasal Esophagoscopy [one week apaart]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt ENT Clinic Nashville Tennessee United States 37232-5280

Sponsors and Collaborators

  • Vanderbilt University

Investigators

  • Principal Investigator: Michael F Vaezi, MD PhD MS, Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00372918
Other Study ID Numbers:
  • 060713
First Posted:
Sep 7, 2006
Last Update Posted:
Jun 5, 2008
Last Verified:
Jun 1, 2008
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2008