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临床试验/NCT00372918
NCT00372918已完成4 期

An Interdisciplinary Interpretation of Transnasal Esophagoscopy Findings

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2006年9月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
98
试验地点
1
主要终点
The intraobserver variability of Transnasal Esophagoscopy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Participants who are unwilling to undergo the study
  • •Patients who have had prior esophagoscopy
  • •Those who do not sign the consent
  • •Pregnant women.

研究组 & 干预措施

1

Other

Transnasal Esophagoscopy

干预措施: Transnasal Esophagoscopy (Procedure)

结局指标

主要结局

The intraobserver variability of Transnasal Esophagoscopy

时间窗: one week apart

The interdisciplinary variability of Transnasal Esophagoscopy

时间窗: one week apaart

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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Interpretation of Transnasal Esophagoscopy Findings | 临床试验