NCT04892966已完成不适用
Texture and Color Enhancement Imaging (TXI) Versus Standard White-light (WLI) Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 747 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 747
- 试验地点
- 2
- 主要终点
- Adenoma Detection Rate (ADR)
研究概览
简要总结
This two parallel arms, randomized, multicenter trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of adenoma detection. Secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All >40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance
排除标准
- •patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD).
- •Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
- •patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale <2 in any colonic segment).
- •patients with previous colonic resection.
- •patients on antithrombotic therapy, precluding polyp resection.
- •patients who were not able or refused to give informed written consent.
结局指标
主要结局
Adenoma Detection Rate (ADR)
时间窗: 1 year
the proportion of participants with at least one adenoma (per-patient analysis)
次要结局
- polyps, adenomas, advanced adenomas and Sessile Serrated Polyps (SSP) per subject(1 year)
- Withdrawal time(1 year)
- Advanced ADR(1 year)
- proximal and flat adenomas detection rate(1 year)
研究者
Giulio Antonelli
MD, Consultant Gastroenterologist, PhD Student
University of Roma La Sapienza
研究点 (2)
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