The COMBO CAD Study: Characterization cOMparison Between twO CAD Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- AI-assisted optical diagnosis performance
研究概览
简要总结
Implementation of clinical strategies based on optical diagnosis of <5 mm colorectal polyps may lead to a substantial saving of economic and financial resources. Despite this, 84.2% of European endoscopists reported not to use such strategies - also named as leave-in situ and resect- and-discard - in their practice due to the fear of an incorrect optical diagnosis.
Indeed, accuracy of optical diagnosis is operator-dependent, and values reported in the community setting are below the safety thresholds proposed for its incorporation in clinical practice.
Artificial intelligence (AI) is being increasingly explored in different domains of medicine, particularly those entailing image analysis. As optical diagnosis involves subitaneous processing of multiple images, searching for specific visual clues, and recognizing well-defined visual patterns, AI systems has the potential to help endoscopists in distinguish neoplastic from non-neoplastic polyps, making the characterization process more reliable and objective. Computer-Aided-Diagnosis systems aiming at characterization are called CADx.
Preliminary data on CADx showed a high feasibility and accuracy of AI for optical diagnosis of colorectal polyp, and initial experiences in clinical practice confirmed preliminary results.
To assess the potential benefit and risk of AI-assisted optical diagnosis with standard colonoscopy, we exploited two new Computer-Aided-Diagnosis systems (CAD-EYE® Fujifilm Co., and GI-Genius® Medtronic) that provide the endoscopist with a real-time polyp characterization without the need of optical magnification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 40 or older undergoing a colonoscopy for gastrointestinal symptoms, fecal immunohistochemical test positivity, primary screening or post-polypectomy surveillance
排除标准
- •subjects with personal history of CRC, or IBD.
- •Subjects 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
AI-assisted optical diagnosis performance
时间窗: 6 Months
AI-assisted optical diagnosis performance
次要结局
- AI alone optical diagnosis performance(6 Months)
