High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,146
- 试验地点
- 1
- 主要终点
- Adenoma detection rate (ADR)
研究概览
简要总结
Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.
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
- 否
入选标准
- •referred for colonoscopy
- •signed informed consent
排除标准
- •subtotal colectomy
- •known colorectal tumor or polyp prior to colonoscopy
- •genetic predisposition to colon cancer namely FAP, HNPCC, Hyperplastic polyposis syndrome, juvenile polyposis, Peutz-Jeghers syndrome
- •inflammatory bowel disease
- •primary sclerosering cholangitis
研究组 & 干预措施
Olympus HD
Olympus high-definition
干预措施: High-definition (Diagnostic Test)
Olympus VC
Olympus virtual chromoendoscopy
干预措施: Virtual chromoendoscopy (Diagnostic Test)
Olympus HD + VC
Olympus high-definition + virtual chromoendoscopy
干预措施: High-definition (Diagnostic Test)
Olympus standard
干预措施: Standard (Diagnostic Test)
Fujinon HD + VC
Fujinon high-definition + virtual chromoendoscopy
干预措施: Virtual chromoendoscopy (Diagnostic Test)
Fujinon HD + VC
Fujinon high-definition + virtual chromoendoscopy
干预措施: High-definition (Diagnostic Test)
Fujinon standard
干预措施: Standard (Diagnostic Test)
Fujinon HD
Fujinon high-definition
干预措施: High-definition (Diagnostic Test)
Olympus HD + VC
Olympus high-definition + virtual chromoendoscopy
干预措施: Virtual chromoendoscopy (Diagnostic Test)
Pentax standard
干预措施: Standard (Diagnostic Test)
Pentax HD
Pentax high-definition
干预措施: High-definition (Diagnostic Test)
Pentax VC
Pentax virtual chromoendoscopy
干预措施: Virtual chromoendoscopy (Diagnostic Test)
Pentax HD + VC
Pentax high-definition + virtual chromoendoscopy
干预措施: High-definition (Diagnostic Test)
Pentax HD + VC
Pentax high-definition + virtual chromoendoscopy
干预措施: Virtual chromoendoscopy (Diagnostic Test)
结局指标
主要结局
Adenoma detection rate (ADR)
时间窗: 7-10 days
Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy.
次要结局
- Number of adenomas(7-10 days)
- Type of adenomas(7-10 days)