Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,905
- 试验地点
- 28
- 主要终点
- Adenoma detection rate
研究概览
简要总结
The investigators plan to conduct a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyp. This study will be performed using web-based research network, e-VELOS in Korea.
详细描述
Various endoscopic tools have been tried to reduce polyp missing rate which has been reported to be 20-25%. Transparent cap-assisted colonoscopy has been suggested to improve visualization of the lesion that are difficult to access, such as tangentially located lesions and those located within a limited luminal space. Chromoendoscopy with indigocarmine spraying was reported to increases the detection rates of polyp, especially in right colon and rectum. However, there also have been mixed results regarding polyp detection rates of the endoscopic methods. Moreover, there is no data regarding the impact of the screening tools on longterm recurrence rate of colorectal polyp. Therefore, in this study, we intend to perform a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyps. This study will be performed using web-based research network, e-VELOS in Korea.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All asymptomatic colonoscopic examinees
排除标准
- •Familial history of hereditary colorectal cancer
- •History of colorectal cancer
- •Patients had received colonoscopy examination before
- •Familial or past history of FAP(familiar adenomatous polyposis)
- •Colonic polyposis syndrome
- •Prior colonic resection of any part of the colon
- •Allergy to indigo carmine
- •Inflammatory bowel disease
- •Pregnancy
- •Inability to provide informed consent
结局指标
主要结局
Adenoma detection rate
时间窗: 7 days is needed to confirm the pathologic examination.
The proportion of subjects with at least one adenoma
次要结局
- Advanced adenoma detection rate(7 days is needed to confirm the pathologic examination.)
- Cancer detection rate(7 days is needed to confirm the pathologic examination.)
- Surveillance(7 - 14 days)
- Serrated adenoma detection rate(7 days is needed to confirm the pathologic examination.)
- Proximal adenoma detection rate(7 days is needed to confirm the pathologic examination.)
- Proximal serrated polyp detection rate(7 days is needed to confirm the pathologic examination.)
研究者
Hyun-Soo Kim
Professor
Korean Association for the Study of Intestinal Diseases