NCT01184781已完成不适用
Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.
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
- 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
- 否
入选标准
- •Age > 18 years old
- •Patient with 40 years old and first degree relative affected by colo rectal cancer at age ≥ 60 ans
- •Patient with 40 years old or ten years before the age at affected disease in case or first deree relative colo rectal cancer before 60 years old.
- •Fecal occult blood test positive
- •Personal history of adenomatous polyps
- •Personnal history of acromegaly
- •Patient with social insurance
- •Persons already participating in another clinical trial..
- •Signature of informed consent
排除标准
- •Pregnancy or breast feeding woman
- •Déficience mentale du sujet rendant sa participation à l'essai impossible
- •Pacemaker or all electronic devices implanted
- •Patient with swallowing disorder, or digestive stricture know or suspected by the investigator
- •Previous history of intestinal surgery, radiotherapy or inflammatory bowel disease
- •Previous history of polyadenomatous congenital disease, Lynch syndrome
- •Intolerance with dompéridon and/or bisacodyl
- •Intolerance with oral intake of NaP, polyethylen glycol (PEG) or macrogol
- •Colonoscopy contre indication for anesthesiologic reasons
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 7 days
The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer.
次要结局
- Pain Scores on the Visual Analog Scale(7 days)
研究者
研究点 (3)
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