PillCam Colon Capsule 2® (PCC2) in the Setting of Colorectal Cancer Screening (CRC) Program: Comparison With a New Integrated Reference Standard
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Sensitivity of PillCam Colon Capsule 2 (R) in identifying significant colonic polyps
研究概览
简要总结
In this study the investigators evaluate the sensitivity of PCC2 (PillCam Colon Capsule 2 (R)) in identifying significant polyps in a CRC (Colo Recatal Cancer) screening program (primary outcome measure).
Each enrolled patient underwent three procedures: colon capsule endoscopy, CT-colonography and optical colonoscopy. In this study the reference standard is represented by the segmental unblinded colonoscopy (the unblinding is based on results of both capsule endoscopy and Ct colonography) The investigators also evaluated the tolerability of PCC2 as compared to optical colonoscopy (OC) and CT-colonography (CTC).
详细描述
Asymptomatic average risk subjects with positive iFOBT (immunochemical Fecal Occult Blood Test), participating the regional screening program, were offered to undergo PCC2 (PillCam Colon Capsule 2 (R)) followed, 21 days later, by CTC and OC performed on the same day. The number, size and location of significant polyps (>6mm) identified by each procedure were compared with the reference standard (RS), which was represented by the segmental unblinded colonoscopy. The unblinding was based on the integration of CTC and PCC2 results. For the PPC2 the quality of the bowel preparation (adequate/inadequate) and the completeness of the examination (capsule excreted still working or visualization of the anal verge) were also reported. In order to evaluate the tolerability, each subject was asked to identify, among the 3 procedures performed, which was the less tolerated one and which one he would be willing to repeat.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •asymptomatic average risk subjects, participating the regional colon cancer screening program, with positive iFOBT referred for colonoscopy
排除标准
- •presence of obstructive symptoms
- •swallowing disorders
- •presence of cardiac pacemaker
结局指标
主要结局
Sensitivity of PillCam Colon Capsule 2 (R) in identifying significant colonic polyps
时间窗: participants are followed for about 1 month
The number, size and location of significant polyps (\>6mm) identified by each procedure were compared with the reference standard (RS), which was represented by the segmental unblinded colonoscopy.
次要结局
- to evaluate the tolerability of PCC2 as compared to optical colonoscopy (OC) and CT-colonography (CTC).(participants are followed for about 1 month)
研究者
Emanuele Rondonotti
MD, PhD
Valduce Hospital