跳至主要内容
临床试验/NCT01204931
NCT01204931已完成不适用

Can We Predict Who Has GERD? Systematic Evaluation of Role of pH Monitoring and the Specific Physiologic pH Parameters in Defining GERD, Bravo, Impedence and SISAP

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 254 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
254
试验地点
1
主要终点
Symptom Index (SI) and Symptom Associated Probability (SAP)

研究概览

简要总结

Gastroesophageal reflux disease (GERD) is currently defined as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications". Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group pH monitoring has emerged as an important physiologic test to determine the degree of esophageal acid exposure and to assess the association between patients' persistent symptoms and acid reflux events. The aims of this study are to assess the sensitivity and specificity of symptom associated indices and determine the best parameter for predicting GERD from a list of conventional pH measurement findings.

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

  • Male and female subjects ages 18 or older
  • Presenting to the Vanderbilt GI outpatient clinic with symptoms of GERD
  • Undergoing upper endoscopy and wireless pH monitoring (standard of care)
  • Erosive disease: presence of esophageal mucosal injuries documented
  • Non-erosive disease: normal esophagogastroduodenoscopy (EGD) with symptoms
  • Control group: normal subjects without symptoms of GERD

排除标准

  • Anti-reflux therapy within 7 days prior to the pH study
  • Previous neck, esophagus, or stomach surgery
  • Major motility disorders
  • Previous neck, esophagus, or stomach cancer or radiations

结局指标

主要结局

Symptom Index (SI) and Symptom Associated Probability (SAP)

时间窗: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring

Assess the sensitivity and specificity of symptom association indices (SI and SAP)regarding gastroesophageal reflux disease (GERD)

Predicting gastroesophageal reflux disease (GERD)

时间窗: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring

Determine the best parameter for predicting gastroesophageal reflux disease (GERD) from a list of conventional pH measurement findings.

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

研究点 (1)

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