Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Diagnostic efficacy
研究概览
简要总结
Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax).
Several previous studies have indicated that NBI without magnification can be useful for real-time differentiation of diminutive colonic neoplasias.
To date, however, there are no studies comparing NBI with other imaging systems (FICE or i-Scan) for differentiation of diminutive colonic polyps.
The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in real-time prediction of diminutive colonic polyps.
In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will be observed with conventional colonoscopy, thereafter will be observed with new imaging systems.
Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by reference to histological results obtained by endoscopic biopsy or polypectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •screening or surveillance colonoscopy
- •age over 18
- •informed consent
排除标准
- •history of inflammatory bowel diseases
- •history of hereditary colorectal cancers and polyposis syndrome
- •inability to give informed consent
- •use of antiplatelet agent and anticoagulants
- •pregnancy
结局指标
主要结局
Diagnostic efficacy
时间窗: about 1 year
Sensitivity, specificity, and diagnostic accuracy
次要结局
未报告次要终点
研究者
Chang Kyun Lee
MD, PhD
Soon Chun Hyang University