Background

Artificial intelligence systems have been developed to improve polyp detection. We aimed to evaluate the effect of real-time computer-aided detection (CADe) on the adenoma detection rate (ADR) in routine colonoscopy.

Methods

This single-centre randomised controlled trial (COLO-GENIUS) was done at the Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France. All consecutive individuals aged 18 years or older who were scheduled for a total colonoscopy and had an American Society of Anesthesiologists score of 1–3 were screened for inclusion. After the caecum was reached and the colonic preparation was appropriate, eligible participants were randomly assigned (1:1; computer-generated random numbers list) to either standard colonoscopy or CADe-assisted colonoscopy (GI Genius 2.0.2; Medtronic). Participants and cytopathologists were masked to study assignment, whereas endoscopists were not. The primary outcome was ADR, which was assessed in the modified intention-to-treat population (all randomly assigned participants except those with misplaced consent forms). Safety was analysed in all included patients. According to statistical calculations, 20 endoscopists from the Clinique Paris-Bercy had to include approximately 2100 participants with 1:1 randomisation. The trial is complete and registered with ClinicalTrials.gov, NCT04440865.

Findings

Between May 1, 2021, and May 1, 2022, 2592 participants were assessed for eligibility, of whom 2039 were randomly assigned to standard colonoscopy (n=1026) or CADe-assisted colonoscopy (n=1013). 14 participants in the standard group and ten participants in the CADe group were then excluded due to misplaced consent forms, leaving 2015 participants (979 [48·6%] men and 1036 [51·4%] women) in the modified intention-to-treat analysis. ADR was 33·7% (341 of 1012 colonoscopies) in the standard group and 37·5% (376 of 1003 colonoscopies) in the CADe group (estimated mean absolute difference 4·1 percentage points [95% CI 0·0–8·1]; p=0·051). One bleeding event without deglobulisation occurred in the CADe group after a large (>2 cm) polyp resection and resolved after a haemostasis clip was placed during a second colonoscopy.

Interpretation

Our findings support the benefits of CADe, even in a non-academic centre. Systematic use of CADe in routine colonoscopy should be considered.

Funding

None.

中文翻译：

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常规结肠镜检查中计算机辅助实时检测结直肠腺瘤的效果（COLO-GENIUS）：单中心随机对照试验

背景

人工智能系统的开发旨在改善息肉检测。我们的目的是评估实时计算机辅助检测（CADe）对常规结肠镜检查中腺瘤检出率（ADR）的影响。

方法

这项单中心随机对照试验(COLO-GENIUS) 在消化内窥镜检查室进行，Pôle Digestif Paris-Bercy，Clinique Paris-Bercy，夏朗东勒蓬，法国。对所有计划进行全结肠镜检查且美国麻醉医师协会评分为 1-3 的连续 18 岁或以上个体进行筛选。到达盲肠且结肠准备适当后，符合条件的参与者被随机分配（1:1；计算机生成的随机数字列表）接受标准结肠镜检查或 CADe 辅助结肠镜检查（GI Genius 2.0.2；美敦力）。参与者和细胞病理学家对研究任务不知情，而内窥镜医师则不然。主要结局是 ADR，在修改后的意向治疗人群中进行评估（所有随机分配的参与者，除了那些错误同意的参与者）形式）。对所有纳入的患者进行安全性分析。根据统计计算，巴黎贝西诊所的 20 名内窥镜医师必须以 1:1 随机化的方式纳入约 2100 名参与者。该试验已完成并在ClinicalTrials.gov注册，NCT04440865。

发现

2021年5月1日至2022年5月1日期间，对2592名参与者进行了资格评估，其中2039名参与者被随机分配接受标准结肠镜检查（n=1026）或CADe辅助结肠镜检查（n=1013）。标准组的 14 名参与者和 CADe 组的 10 名参与者因同意书放错位置而被排除，留下 2015 名参与者（979 [48·6%] 男性和 1036 [51·4%] 女性）参与修改后的意向性研究。 -治疗分析。标准组的 ADR 为 33·7%（1012 例结肠镜检查中的 341 例），CADe 组为 37·5%（1003 例结肠镜检查中的 376 例）（估计平均绝对差异 4·1 个百分点 [95% CI 0·0–8] ·1]；p=0·051)。CADe 组在大（> 2 cm）息肉切除后发生了一起没有去球化的出血事件，并在第二次结肠镜检查期间放置止血夹后解决。

解释

我们的研究结果支持了 CADe 的好处，即使是在非学术中心也是如此。应考虑在常规结肠镜检查中系统地使用 CADe。

资金

没有任何。