Image-Enhanced Endoscopy for the Diagnosis of Non-Erosive Reflux Disease: A Prospective Case-Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Squamo-columnar junction vascularity (graded as present or absent by endoscopist using IEE)
研究概览
简要总结
When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not respond to conventional treatment (a class of medications called proton pump inhibitors), it is important to be able to distinguish between erosive GERD and non-erosive GERD (called NERD).
Currently the best method the investigators have to make this distinction is esophageal 24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus through the nose and having the catheter maintained in this position for 24 hours This test is invasive, can be uncomfortable, and it is expensive and time consuming.
The investigators are hoping that image enhanced technology will identify characteristics that are found more commonly in patients with non-erosive GERD compared to controls and therefore provide evidence that may allow us to replace pH and impedance testing with the image enhanced endoscopy as the best way to diagnose NERD.
Participants will be either patients undergoing an upper endoscopy as part of their standard clinical evaluation for heartburn that does not respond to PPIs or patients undergoing standard clinical evaluation endoscopy for other reasons.
详细描述
Evaluation of the utility of image-enhanced endoscopy (IEE) in the diagnosis of non-erosive reflux disease (NERD), defined as heartburn documented to be associated with reflux on impedance-pH testing in the absence of erosions on standard white-light endoscopy (WLE) during initial endoscopy.
The investigators will examine the following characteristics for IEE sensitivity, specificity, positive predictive values, and negative predictive value: squamo-columnar junction (SCJ) vascularity, micro-erosions, SCJ pit pattern, and combinations of these characteristics. The investigators will also look at abnormal morphology of intra-papillary capillary loops (IPCLS) using the newer generation Narrow Band Light (NBI-190 endoscopes and assess the identification of their presence using I-scan. Additionally, the investigators will examine real-time diagnostic yield of reflux diseases by IEE (in vivo diagnosis of reflux disease) and analyze obtained images and results to calculate inter-observer agreement.
IEE utilized will be commonly available I-scan (Pentax) and Narrow Band Imaging (Olympus).
Consecutive patients who meet eligibility criteria and are scheduled for upper endoscopy at locations specified in this record will be invited to participate.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for an upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices without heartburn or other GERD symptoms and patients scheduled for upper endoscopy for heartburn not resolving with PPIs
排除标准
- •Patients who have evidence of erosive esophagitis under white-light endoscopy
- •Patients with Barrett's esophagus or esophageal malignancy on prior or current endoscopy
- •Patients unable or unwilling to sign informed consent
结局指标
主要结局
Squamo-columnar junction vascularity (graded as present or absent by endoscopist using IEE)
时间窗: Once--at endoscopy
次要结局
- Presence or absence of micro-erosions identified by endoscopist using IEE(Once at endoscopy)
- Squamo-columnar junction pit pattern (graded as round or non-round by endoscopist using IEE)(Once at endoscopy)
研究者
Loren Laine
Professor of Medicine, Digestive Diseases
Yale University