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
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
- 是
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
Michael Vaezi
Medical Director
Vanderbilt University
