跳至主要内容
临床试验/NCT01194323
NCT01194323已完成不适用

Biology in Patients With Reflux Esophagitis and Mucosal Impedance

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Change in local impedance of the esophageal mucosa

研究概览

简要总结

GERD is a common condition in the western world. In most cases, the diagnostic is established by good response to empiric proton pump inhibitor (PPI) therapy. When the patient symptoms are refractory to therapy, multiple invasive tests are available. The results of those tests (EGD, manometry, Ph monitoring and impedance) are clues that the physician use together to establish the diagnostic. No test however can be use alone because of their poor specificity and sensitivity. Recently, microscopy has been used to detect dilated intercellular space in between distal esophageal cells tissue; unfortunately this marker again failed to diagnose GERD.

In search of more sensitive and specific markers of GERD, we propose to assess if acid exposure affects: 1) gene and proteins expression in the esophageal/post-cricoid area tissue; and 2) local impedance of the mucosa. The secondary aim of this proposal is to determine if correlation exists between the two approaches.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • Less than 18 years of age
  • Unable to provide informed consent
  • Use of acid suppressive therapy within last 14 days
  • known history of Barrett's esophagus, gastric surgery, alcoholism, significant motility condition
  • contraindications to biopsy such as taking anticoagulants other than aspirin (coumadin, plavix) or allergies to local anesthetic

结局指标

主要结局

Change in local impedance of the esophageal mucosa

时间窗: Chronic exposure

We are assessing if acid exposure affects local impedance of the mucosa

Change in gene and protein expression due to acid exposure in the esophagus

时间窗: Chronic exposure

We are assessing if acid exposure affects gene and protein expression in the esophageal/post-cricoid area tissue

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Vaezi

Medical Director

Vanderbilt University Medical Center

研究点 (1)

Loading locations...

相似试验