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The Efficacy of Real-time Computer-aided Detection of Colonic Neoplasia in Community Practice: A Pragmatic Randomized Controlled Trial
Clinical Gastroenterology and Hepatology ( IF 12.6 ) Pub Date : 2024-03-02 , DOI: 10.1016/j.cgh.2024.02.021
Nikhil R. Thiruvengadam , Pejman Solaimani , Manish Shrestha , Seth Buller , Rachel Carson , Breanna Reyes-Garcia , Ronaldo D. Gnass , Bing Wang , Natalie Albasha , Paul Leonor , Monica Saumoy , Raul Coimbra , Arnold Tabuenca , Wichit Srikureja , Steve Serrao

The use of computer-aided detection (CADe) has increased the adenoma detection rates (ADRs) during colorectal cancer (CRC) screening/surveillance in randomized controlled trials (RCTs) but has not shown benefit in real-world implementation studies. We performed a single-center pragmatic RCT to evaluate the impact of real-time CADe on ADRs in colonoscopy performed by community gastroenterologists. We enrolled 1100 patients undergoing colonoscopy for CRC screening, surveillance, positive fecal-immunohistochemical tests, and diagnostic indications at one community-based center from September 2022 to March 2023. Patients were randomly assigned (1:1) to traditional colonoscopy or real-time CADe. Blinded pathologists analyzed histopathologic findings. The primary outcome was ADR (the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy (APC), sessile-serrated lesion detection rate, and non-neoplastic resection rate. The median age was 55.5 years (interquartile range, 50–62 years), 61% were female, 72.7% were of Hispanic ethnicity, and 9.1% had inadequate bowel preparation. The ADR for the CADe group was significantly higher than the traditional colonoscopy group (42.5% vs 34.4%; = .005). The mean APC was significantly higher in the CADe group compared with the traditional colonoscopy group (0.89 ± 1.46 vs 0.60 ± 1.12; < .001). The improvement in adenoma detection was driven by increased detection of <5 mm adenomas. CADe had a higher sessile-serrated lesion detection rate than traditional colonoscopy (4.7% vs 2.0%; = .01). The improvement in ADR with CADe was significantly higher in the first half of the study (47.2% vs 33.7%; = .002) compared with the second half (38.7% vs 34.9%; = .33). In a single-center pragmatic RCT, real-time CADe modestly improved ADR and APC in average-detector community endoscopists. ( number, NCT05963724).

中文翻译:

实时计算机辅助检测结肠肿瘤在社区实践中的功效:一项实用的随机对照试验

计算机辅助检测 (CADe) 的使用提高了随机对照试验 (RCT) 结直肠癌 (CRC) 筛查/监测期间的腺瘤检出率 (ADR),但在实际实施研究中尚未显示出益处。我们进行了一项单中心实用性随机对照试验,以评估实时 CADe 对社区胃肠病学家进行的结肠镜检查中 ADR 的影响。我们于 2022 年 9 月至 2023 年 3 月在一个社区中心招募了 1100 名接受结肠镜检查的患者,以进行 CRC 筛查、监测、粪便免疫组织化学检测阳性和诊断指征。患者被随机分配 (1:1) 接受传统结肠镜检查或实时结肠镜检查CAD。盲法病理学家分析了组织病理学结果。主要结局是 ADR(患有至少 1 种组织学证实的腺瘤或癌的患者百分比)。次要结果是结肠镜检查(APC)检出的腺瘤、无蒂锯齿状病变检出率和非肿瘤性切除率。中位年龄为 55.5 岁(四分位数范围,50-62 岁),61% 为女性,72.7% 为西班牙裔,9.1% 肠道准备不足。 CADe 组的 ADR 显着高于传统结肠镜检查组(42.5% vs 34.4%;= .005)。与传统结肠镜检查组相比,CADe 组的平均 APC 显着较高(0.89 ± 1.46 vs 0.60 ± 1.12;< .001)。腺瘤检测的改进是由于 <5 mm 腺瘤的检测增加而推动的。 CADe 的无蒂锯齿状病变检出率高于传统结肠镜检查(4.7% vs 2.0%;= .01)。与研究下半年 (38.7% vs 34.9%; = .33) 相比,CADe 的 ADR 改善在研究的前半部分 (47.2% vs 33.7%; = .002) 显着更高。在单中心实用随机对照试验中,实时 CADe 适度改善了普通检测社区内窥镜医师的 ADR 和 APC。 (编号,NCT05963724)。
更新日期:2024-03-02
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