Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 314
- 试验地点
- 4
- 主要终点
- Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)
研究概览
简要总结
This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy.
The NBI is a so-called "virtual" electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention.
The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient with 1 or more polyps less than 20 mm observed during colonoscopy
排除标准
- •Patient with an emergency colonoscopy for ongoing digestive bleeding or occlusion symptoms
- •Patient with chronic inflammatory bowel disease (IBD): Crohn's disease or unclassified colitis
- •Patient with familial adenomatous polyposis
- •Pregnant or lactating woman
- •Minor patient
- •Major patient under tutorship, curatorship, or deprived of liberty
- •Patient unable to understand protocol and / or give express consent
- •Patient not affiliated with a social security system or beneficiary of such a scheme
- •Patient hospitalized or treated without their consent
结局指标
主要结局
Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)
时间窗: An average of 1 month
Number of polyps characterized as scalloped (NICE II-) by NBI relative to the number of polyps characterized as scalloped in standard histology
次要结局
未报告次要终点