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Interpretation of Transnasal Esophagoscopy Findings (TNE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00372918
First Posted: September 7, 2006
Last Update Posted: June 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
  Purpose
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 Intervention Phase
Larynx Disease Procedure: Transnasal Esophagoscopy Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Interdisciplinary Interpretation of Transnasal Esophagoscopy Findings

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • The intraobserver variability of Transnasal Esophagoscopy [ Time Frame: one week apart ]
  • The interdisciplinary variability of Transnasal Esophagoscopy [ Time Frame: one week apaart ]

Enrollment: 98
Study Start Date: September 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Transnasal Esophagoscopy
Procedure: Transnasal Esophagoscopy
fiberoptic exam of esophagus thru nares

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372918


Locations
United States, Tennessee
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
  More Information

Responsible Party: Michael F. Vaezi, MD, PhD, MS epi, Vanderbilt University Medical Center Department of GI Research
ClinicalTrials.gov Identifier: NCT00372918     History of Changes
Other Study ID Numbers: 060713
First Submitted: September 5, 2006
First Posted: September 7, 2006
Last Update Posted: June 5, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases