Interpretation of Transnasal Esophagoscopy Findings (TNE)
Primary Purpose
Larynx Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Transnasal Esophagoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Larynx Disease
Eligibility 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.
Sites / Locations
- Vanderbilt ENT Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Transnasal Esophagoscopy
Outcomes
Primary Outcome Measures
The intraobserver variability of Transnasal Esophagoscopy
The interdisciplinary variability of Transnasal Esophagoscopy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372918
Brief Title
Interpretation of Transnasal Esophagoscopy Findings
Acronym
TNE
Official Title
An Interdisciplinary Interpretation of Transnasal Esophagoscopy Findings
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Larynx Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Transnasal Esophagoscopy
Intervention Type
Procedure
Intervention Name(s)
Transnasal Esophagoscopy
Intervention Description
fiberoptic exam of esophagus thru nares
Primary Outcome Measure Information:
Title
The intraobserver variability of Transnasal Esophagoscopy
Time Frame
one week apart
Title
The interdisciplinary variability of Transnasal Esophagoscopy
Time Frame
one week apaart
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael F Vaezi, MD PhD MS
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt ENT Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5280
Country
United States
12. IPD Sharing Statement
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Interpretation of Transnasal Esophagoscopy Findings
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