Department of Research and Innovation, South Tyneside and Sunderland NHS Foundation Trust, South Tyneside District Hospital, South Shields, UK; Population Health Sciences Institute, Newcastle University Centre for Cancer, Faculty of Medical Sciences, Newcastle University, Newcastle Upon Tyne, UK.
Population Health Sciences Institute, Newcastle University Centre for Cancer, Faculty of Medical Sciences, Newcastle University, Newcastle Upon Tyne, UK.
Lancet Gastroenterol Hepatol. 2024 Oct;9(10):911-923. doi: 10.1016/S2468-1253(24)00161-4. Epub 2024 Aug 14.
Increased polyp detection during colonoscopy is associated with decreased post-colonoscopy colorectal cancer incidence and mortality. The COLO-DETECT trial aimed to assess the clinical effectiveness of the GI Genius intelligent endoscopy module for polyp detection, comparing colonoscopy assisted by GI Genius (computer-aided detection [CADe]-assisted colonoscopy) with standard colonoscopy in routine practice.
We did a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial in 12 National Health Service (NHS) hospitals (ten NHS Trusts) in England, among adults (aged ≥18 years) undergoing planned colonoscopy for gastrointestinal symptoms or for surveillance due to personal or family history (ie, symptomatic indications), or colorectal cancer screening. Randomisation (1:1) to CADe-assisted colonoscopy or standard colonoscopy was done with a web-based dynamic adaptive algorithm, immediately before colonoscopy, with stratification by age group, sex, colonoscopy indication (screening or symptomatic), and NHS Trust. Recruiting staff, participants, and colonoscopists were unmasked to trial allocation; histopathologists, co-chief investigators, and trial statisticians were masked. CADe-assisted colonoscopy consisted of standard colonoscopy plus the GI Genius module active for at least the entire inspection phase of colonoscope withdrawal. The primary outcome was mean adenomas per procedure (total number of adenomas detected divided by total number of procedures); the key secondary outcome was adenoma detection rate (proportion of colonoscopies with at least one adenoma). Analysis was by intention to treat (ITT), with outcomes compared between groups by mixed-effects regression modelling, in which effect estimates were adjusted for randomisation stratification variables. Data were imputed for outcome measures with more than 5% missing values. All participants who underwent colonoscopy were assessed for safety. The trial is registered on ISRCTN (ISRCTN10451355) and ClinicalTrials.gov (NCT04723758), and is complete.
Between March 29, 2021, and April 6, 2023, 2032 participants (1132 [55·7%] male, 900 [44·3%] female; mean age 62·4 years [SD 10·8]) were recruited and randomly assigned: 1015 to CADe-assisted colonoscopy and 1017 to standard colonoscopy. 1231 (60·6%) participants were undergoing screening and 801 (39·4%) had symptomatic indications. Mean adenomas per procedure was 1·56 (SD 2·82; n=1001 participants with available data) in the CADe-assisted colonoscopy group versus 1·21 (1·91; n=1009) in the standard colonoscopy group, representing an adjusted mean difference of 0·36 (95% CI 0·14-0·57; adjusted incidence rate ratio 1·30 [95% CI 1·15-1·47], p<0·0001). Adenomas were detected in 555 (56·6%) of 980 participants in the CADe-assisted colonoscopy group versus 477 (48·4%) of 986 in the standard colonoscopy group, representing a proportion difference of 8·3% (95% CI 3·9-12·7; adjusted odds ratio 1·47 [95% CI 1·21-1·78], p<0·0001). Numbers of adverse events were similar between the CADe-assisted colonoscopy and standard colonoscopy groups (adverse events: 25 vs 19; serious adverse events: four vs six), and no adverse events in the CADe-assisted colonoscopy group were deemed to be related to GI Genius use on independent review.
Results of the COLO-DETECT trial support the use of GI Genius to increase detection of premalignant colorectal polyps in routine colonoscopy practice.
Medtronic.
结肠镜检查中息肉检出率的增加与结直肠癌发病率和死亡率的降低有关。COLO-DETECT 试验旨在评估 GI Genius 智能内镜模块在息肉检测方面的临床效果，将 GI Genius 辅助的结肠镜检查（计算机辅助检测 [CADe]-辅助结肠镜检查）与常规实践中的标准结肠镜检查进行比较。
我们在英格兰的 12 家国民保健服务（NHS）医院（10 家 NHS 信托）进行了一项多中心、开放性、平行臂、实用随机对照试验，纳入了接受计划结肠镜检查的成年人（年龄≥18 岁），这些患者的检查原因包括胃肠道症状或因个人或家族史（即症状指征）、结直肠癌筛查而进行的监测。通过基于网络的动态自适应算法，在结肠镜检查前立即对 CADe-辅助结肠镜检查或标准结肠镜检查进行随机分组（1:1），并按年龄组、性别、结肠镜检查指征（筛查或症状）和 NHS 信托进行分层。招募工作人员、参与者和结肠镜检查医生均未参与试验分配；病理学家、共同首席研究员和试验统计学家进行了盲法。CADe-辅助结肠镜检查包括标准结肠镜检查加 GI Genius 模块，该模块在结肠镜检查退镜的整个检查阶段至少处于活动状态。主要结局是每例手术的平均腺瘤数（检测到的腺瘤总数除以手术总数）；关键次要结局是腺瘤检出率（至少检出一个腺瘤的结肠镜检查比例）。分析采用意向治疗（ITT），通过混合效应回归模型比较组间结局，在模型中，效应估计值根据随机化分层变量进行调整。对于缺失值超过 5%的结局测量指标进行了数据插补。所有接受结肠镜检查的患者均进行了安全性评估。该试验在 ISRCTN（ISRCTN10451355）和 ClinicalTrials.gov（NCT04723758）上注册，现已完成。
2021 年 3 月 29 日至 2023 年 4 月 6 日，共纳入 2032 名参与者（1132 名[55.7%]男性，900 名[44.3%]女性；平均年龄 62.4 岁[标准差 10.8]），并随机分为 CADe-辅助结肠镜检查组（n=1015）和标准结肠镜检查组（n=1017）。1231 名（60.6%）参与者接受筛查，801 名（39.4%）有症状指征。在可获得数据的 1001 名参与者中，CADe-辅助结肠镜检查组的平均腺瘤数为 1.56（标准差 2.82），而标准结肠镜检查组为 1.21（1.91），调整后的平均差异为 0.36（95%置信区间 0.14-0.57；调整后的发病率比 1.30[95%置信区间 1.15-1.47]，p<0.0001）。在可获得数据的 1009 名参与者中，CADe-辅助结肠镜检查组中有 555 名（56.6%）检测到腺瘤，而标准结肠镜检查组中有 477 名（48.4%），差异比例为 8.3%（95%置信区间 3.9-12.7；调整后的优势比 1.47[95%置信区间 1.21-1.78]，p<0.0001）。CADe-辅助结肠镜检查组和标准结肠镜检查组的不良事件数量相似（不良事件：25 例 vs 19 例；严重不良事件：4 例 vs 6 例），并且在 CADe-辅助结肠镜检查组中，没有不良事件被认为与 GI Genius 的使用有关。
COLO-DETECT 试验的结果支持在常规结肠镜检查实践中使用 GI Genius 来增加癌前结直肠息肉的检出率。
美敦力公司。
