Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- Accuracy of In Vivo determination of colorectal polyps histopathology
研究概览
简要总结
The investigators seek to compare the accuracy of the existing colonoscope model to determine the magnitude of the improvement the investigators can expect in polyp discrimination as neoplastic or non-neoplastic.
详细描述
Information will be collected. Images will be taken.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 18 and older
- •Presenting for surveillance, screening or diagnostic colonoscopy
- •Willingness to provide informed consent
排除标准
- •Inability to provided informed consent
- •Pregnancy
- •Known inflammatory bowel disease
- •Personal or family history of polyposis or nonpolyposis syndrome
- •Emergency colonoscopy/endoscopy
- •Coagulopathy or thrombocytopenia preventing polypectomy
- •Procedure indication for acute bleeding or active colitis
结局指标
主要结局
Accuracy of In Vivo determination of colorectal polyps histopathology
时间窗: 1 year
Compare accuracy of current colonoscope to improved colonoscope for discrimination of polyps as neoplastic versus non-neoplastic. The accuracies of the two approaches will be compared via logistic regression model with the significance of the difference in the accuracies assessed via generalized estimating equation approach to take account of the possible dependence introduced by inclusion of mulitple polyps per patient.
次要结局
- Sensitivity and specificity of In Vivo discrimination of colorectal polyp histopathology in white light and narrow band imaging modes.(1 year)