Detection and Classification of Colon Polyps: A Comparison of High Definition White Light and Narrow Band Imaging (Endoscopic Trimodal Imaging; ETMI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- 1. Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI
研究概览
简要总结
Colon cancer is the third most common cancer in western society. To prevent colon cancer it is recommended for people to undergo a screening colonoscopy at the age of fifty. The purpose of the colonoscopy is to remove polyps, since some of these lesions are precancerous. Precancerous polyps are called adenomas. This method of prevention is effective, but the standard colonoscopy currently used does not detect all polyps. Studies have reported a polyp miss rate of about 24%. Furthermore, we are unable to distinguish precancerous polyps from benign polyps, also known as hyperplastic polyps, with standard colonoscopy. This results in all polyps being removed at time of colonoscopy, even the benign polyps.
To help improve the detection of colon polyps new endoscopic technologies have been developed. These technologies include high definition white light (HDWL)and high definition narrow band imaging (HDNBI). HDWL improves the overall resolution of the images seen during colonoscopy. HDNBI can help us better classify polyps by enhancing their tissue appearance as well as seeing small blood vessels and capillaries.
The goal of this study to determine if HDNBI imaging shows an increased polyp detection rate when compared to the current standard colonoscopy. In addition to develop a classification system to help better differentiate between precancerous polyps and their benign counterparts using HDWL and HDNBI.
详细描述
II. Hypothesis:
- The use of NBI colonoscopy will reduce the miss rate for colon polyps compared to standard white light imaging.
- HDWl and HDNBI are more accurate than standard colonoscopy for the classification of adenomatous polyps in comparison to other non-premalignant polyps.
III. Specific Aims:
- Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI
- Estimate the accuracy of standard white light, HDWL and HDNBI imaging modes for the classification of adenomatous (premalignant) versus non-adenomatous (hyperplastic, inflammatory, normal) polyps.
- Examine the inter-observer agreement for classification of adenomatous versus non-adenomatous polyps based on standard, NBI and HDWL imaging.
IV. Research Design and Methods:
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
- 是
入选标准
- •Age 18 years or older.
- •Informed written consent
排除标准
- •History of inflammatory bowel disease.
- •Patients with severe cardiopulmonary disease precluding colonoscopy.
- •Presence of conditions not allowing for polypectomy or biopsy (e.g. coagulation disorder).
- •Known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc)
- •Sub-optimal preparation for the procedure, which will be determined by patient history or based on the initial colonoscopy.
结局指标
主要结局
1. Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI
时间窗: 2 years
次要结局
- 2. Estimate the accuracy of standard white light, HDWL and HDNBI imaging modes for the classification of adenomatous (premalignant) versus non-adenomatous (hyperplastic, inflammatory, normal) polyps.(2 years)