A Prospective Clinical Study to Evaluate Narrow Band Imaging and Magnifying Colonoscopy for the Histologic Prediction of Colorectal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification
研究概览
简要总结
The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.
详细描述
The accuracy of histologic prediction for the colorectal polyps with the use of narrow band imaging is evaluated between the test group with magnifying colonoscopy and the control group without magnifying colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with colorectal polyps which are in need of EMR
排除标准
- •pregnancy, IBD, colorectal cancer, etc.
研究组 & 干预措施
control group
histologic prediction only with the narrow band imaging (without magnification)
test group
histologic prediction with narrow band imaging plus magnification
干预措施: NBI with magnification (Device)
结局指标
主要结局
Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification
时间窗: After 1 week
After radomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. After 1 week, confirmed pathologic diagnosis and predicted histologic diagnosis based on endoscopic observation are compared and its accuracy is evaluated.
次要结局
- Sensitivity of the endoscopic histologic prediction with NBI plus magnification(1 Week)
- Specificity of the endoscopic histologic prediction with NBI plus magnification(1 Week)
- Positive predictive value of the endoscopic histologic prediction with NBI plus magnification(1 Week)
- Negative predictive value of the endoscopic histologic prediction with NBI plus magnification(1 Week)