Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study
Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study
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DOI：
10.1016/s2468-1253(19)30411-x
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发表时间：
2020-04-01
影响因子：
35.7
通讯作者：
Zhou, Guanyu
中科院分区：
文献类型：
--
作者：
Wang, Pu;Liu, Xiaogang;Zhou, Guanyu
背景 非盲试验表明，采用计算机辅助检测 (CADe) 的结肠镜检查可通过在手术过程中提供视觉警报来改善对结肠息肉和腺瘤的检测。我们的目的是评估CADe系统的有效性，避免潜在的操作偏差。方法我们在中国四川省人民医院草堂分院内窥镜中心进行了双盲随机试验。我们连续招募了接受诊断和筛查结肠镜检查的患者（年龄 18-75 岁）。我们排除了有炎症性肠病、结直肠癌或结直肠手术史或有活检禁忌的患者；我们还排除了之前进行过结肠镜检查不成功以及高度怀疑患有息肉病综合征、炎症性肠病和结直肠癌的患者。我们将患者（1:1）分配到使用 CADe 系统或假系统进行结肠镜检查。随机化是由计算机生成的随机数分配。患者和内窥镜医师不知道随机分配。为了实现屏蔽，系统的输出显示在第二个监视器上，只有负责报告警报的观察员才能看到该监视器。主要结果是腺瘤检出率（ADR），即接受从盲肠到直肠的完整结肠镜检查后检出一个或多个腺瘤的个体比例。主要分析是按照方案进行的。我们还分析了最初被内窥镜医师漏掉但被 CADe 系统检测到的息肉和腺瘤的特征。该试验已完成并在http://www.chictrorg.cn注册，ChiCTR1800017675。结果2018年9月3日至2019年1月11日期间，1046名患者入组该研究，其中36名患者在随机分组前被排除，508名患者接受了使用CADe系统进行结肠镜检查和息肉检测，502名患者接受了假结肠镜检查系统。进一步排除符合排除标准的患者后，CADe组484例患者和假手术组478例患者纳入分析。 CADe 组的 ADR 显着高于假手术组，分配到 CADe 系统的 484 名患者中有 165 名 (34%) 检测到一种或多种腺瘤，而分配到假手术组的 478 名患者中有 132 名 (28%) 被分配到假手术组（比值比 1.36，95% CI 1. 03-1. 79；p=0.030）。所有结肠镜检查过程中均未报告并发症。最初被内窥镜医师漏诊但被 CADe 系统识别出的息肉通常尺寸较小、等色、形状扁平、边界不清晰、部分位于结肠皱襞后面、位于视野边缘。这种息肉可以在结肠镜检查过程中使用高性能 CADe 系统来检测。应研究结肠镜检查期间 CADe 对间期结直肠癌发病率的影响。版权所有 (C) 2020 爱思唯尔有限公司。保留所有权利。
Background Colonoscopy with computer-aided detection (CADe) has been shown in non-blinded trials to improve detection of colon polyps and adenomas by providing visual alarms during the procedure. We aimed to assess the effectiveness of a CADe system that avoids potential operational bias.Methods We did a double-blind randomised trial at the endoscopy centre in Caotang branch hospital of Sichuan Provincial People's Hospital in China. We enrolled consecutive patients (aged 18-75 years) presenting for diagnostic and screening colonoscopy. We excluded patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery or who had a contraindication for biopsy; we also excluded patients who had previously had an unsuccessful colonoscopy and who had a high suspicion for polyposis syndromes, inflammatory bowel disease, and colorectal cancer. We allocated patients (1:1) to colonoscopy with either the CADe system or a sham system. Randomisation was by computer-generated random number allocation. Patients and the endoscopist were unaware of the random assignment. To achieve masking, the output of the system was shown on a second monitor that was only visible to an observer who was responsible for reporting the alerts. The primary outcome was the adenoma detection rate (ADR), which is the proportion of individuals having a complete colonoscopy, from caecum to rectum, who had one or more adenomas detected. The primary analysis was per protocol. We also analysed characteristics of polyps and adenomas missed initially by endoscopists but detected by the CADe system. This trial is complete and is registered with http://www.chictrorg.cn , ChiCTR1800017675.Findings Between Sept 3, 2018, and Jan 11, 2019, 1046 patients were enrolled to the study, of whom 36 were excluded before randomisation, 508 were allocated colonoscopy with polyp detection using the CADe system, and 502 were allocated colonoscopy with the sham system. After further excluding patients who met exclusion criteria, 484 patients in the CADe group and 478 in the sham group were induded in analyses. The ADR was significantly greater in the CADe group than in the sham group, with 165 (34%) of 484 patients allocated to the CADe system having one or more adenomas detected versus 132 (28%) of 478 allocated to the sham system (odds ratio 1.36, 95% CI 1. 03-1. 79; p=0.030). No complications were reported among all colonoscopy procedures. Polyps initially missed by the endoscopist but identified by the CADe system were generally small in size, isochromatic, flat in shape, had an unclear boundary, were partly behind colon folds, and were on the edge of the visual field.Interpretation Polyps initially missed by the endoscopist had characteristics that are sometimes difficult for skilled endoscopists to recognise. Such polyps could be detected using a high-performance CADe system during colonoscopy. The effect of CADe during colonoscopy on the incidence of interval colorectal cancer should be investigated. Copyright (C) 2020 Elsevier Ltd. All rights reserved.