JPRN-jRCTs032190061已完成3 期
The validation study of detectability and diagnostic accuracy of AI-aided endoscopic diagnosis system for colonoscopy; multicentric study - CAD-COLON study
Tamai Naoto0 个研究点目标入组 358 人开始时间: 2019年7月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 358
研究概览
简要总结
A total of 358 patients were enrolled and 179 patients were assigned to the SC-first group or CADe-first group. The AMR of the CADe-first group was significantly lower than that of the SC-first group (13.8%vs.36.7%,P<0.0001). Similar results were observed for the polyp miss rate (14.2%vs.40.6%,P<0.0001). The adenoma detection rate of CADe-assisted colonoscopy was 64.5%, which was significantly higher than that of standard colonoscopy (53.6%;P=0.036).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 < 80age old（—）
- 性别
- All
入选标准
- •In patients scheduled for colonoscopy / treatment, patients who meet the following criteria.
- •1.40-80 years old
- •2.Patients who gave written informed consent based on their own intention after receiving sufficient explanation about this study
- •3.Informed consensus has been obtained that endoscopic resection should be performed if a lesion is found
- •4.The examination purpose is for screening of colon cancer or surveillance after endoscopic treatment of colorectal lesions
排除标准
- •1.Patients with known inflammatory bowel disease and colonic stenosis
- •2.Patients with known familial adenomatous polyposis syndrome
- •3.Patients with known colorectal cancer/polyp
- •4.Patients who have had colon surgery in the past (except for appendectomy and surgery on the anus)
- •5.Patients with high risk of bleeding after endoscopic treatment, and difficult management of anticoagulation or antiplatelet agent.
- •6.Patients with severe organ failure (cirrhosis of Child C, heart failure of ACC / AHA stage D)
- •7.Pregnant patient
- •8.Patients who are judged as ineligible for registration by attending doctors
研究者
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