Confocal Laser Microscopy in Non Erosive Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD
研究概览
简要总结
Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this study is to identify the use of this new technique in diagnosing reflux in patients who have normal appearing esophagus.
详细描述
Gastroesophageal reflux disease (GERD) remains a major problem in the United States affecting about 20% of Americans. Upper endoscopy (EGD) is commonly used to diagnose and grade GERD based on mucosal breaks and erosions. It is now evident from multiple studies however that the majority of GERD patients (50-70%) have negative EGDs.These patients are refered to as "Non Erosive Reflux Disease" (NERD) patients.Confocal Laser Microscopy (CLM) is a new endoscopic technique that offers the advantage of detecting histologic changes during real time endoscopy and thus can diagnose NERD. We thus propose to study the sensitivity and specificity of CLM in predicting NERD. We hypothesize that CLM can reliably diagnose NERD in the appropriate clinical setting based on intrapapillary capillary loop patterns. This will be a pilot study after which a randomized trial will evaluate the reversibility of these changes after PPI therapy as seen by CLM
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years to 85 years old who are referred for an upper endoscopy for symptoms of reflux disease
- •Patients who are able to give informed consent
排除标准
- •Patients with a history of Erosive esophagitis
- •Patients with a history of Barrett's esophagus
- •Patients who on upper endoscopy have any current evidence of erosive esophagitis, Barrett's esophagus or varices
- •Patients who are unable or unwilling to undergo endoscopic evaluation
- •Patients who are unable to give informed consent
- •Patients with a known coagulopathy who are unable to be off therapy
结局指标
主要结局
To assess the sensitivity, specificity, negative and positive predictive value of CLM in diagnosing NERD
时间窗: at time of procedure
次要结局
- To assess the additional charges of implementing CLM in EGD(at time of procedure)
研究者
Kenneth K. Wang
VanCleve Professor of Gastroenterology Research
Mayo Clinic