Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Tenerife, Spain.
Unidad de Investigación, Hospital Universitario de Canarias, Tenerife, Spain.
Gastrointest Endosc. 2023 Mar;97(3):528-536.e1. doi: 10.1016/j.gie.2022.09.029. Epub 2022 Oct 11.
BACKGROUND AND AIMS: Artificial intelligence-based computer-aid detection (CADe) devices have been recently tested in colonoscopies, increasing the adenoma detection rate (ADR), mainly in Asian populations. However, evidence for the benefit of these devices in the occidental population is still low. We tested a new CADe device, namely, ENDO-AID (OIP-1) (Olympus, Tokyo, Japan), in clinical practice. METHODS: This randomized controlled trial included 370 consecutive patients who were randomized 1:1 to CADe (n = 185) versus standard exploration (n = 185) from November 2021 to January 2022. The primary endpoint was the ADR. Advanced adenoma was defined as ≥10 mm, harboring high-grade dysplasia, or with a villous pattern. Otherwise, the adenoma was nonadvanced. ADR was assessed in both groups stratified by endoscopist ADR and colon cleansing. RESULTS: In the intention-to-treat analysis, the ADR was 55.1% (102/185) in the CADe group and 43.8% (81/185) in the control group (P = .029). Nonadvanced ADRs (54.8% vs 40.8%, P = .01) and flat ADRs (39.4 vs 24.8, P = .006), polyp detection rate (67.1% vs 51%; P = .004), and number of adenomas per colonoscopy were significantly higher in the CADe group than in the control group (median [25th-75th percentile], 1 [0-2] vs 0 [0-1.5], respectively; P = .014). No significant differences were found in serrated ADR. After stratification by endoscopist and bowel cleansing, no statistically significant differences in ADR were found. CONCLUSIONS: Colonoscopy assisted by ENDO-AID (OIP-1) increases ADR and number of adenomas per colonoscopy, suggesting it may aid in the detection of colorectal neoplastic lesions, especially because of its detection of diminutive and flat adenomas. (Clinical trial registration number: NCT04945044.).
背景与目的:基于人工智能的计算机辅助检测(CADe)设备最近已在结肠镜检查中进行了测试,提高了腺瘤检出率(ADR),主要是在亚洲人群中。然而,这些设备在西方人群中获益的证据仍然较少。我们在临床实践中测试了一种新的 CADe 设备,即 ENDO-AID(OIP-1)(奥林巴斯,东京,日本)。
方法:这项随机对照试验纳入了 2021 年 11 月至 2022 年 1 月期间连续 370 例随机 1:1 分配至 CADe 组(n=185)或标准探查组(n=185)的患者。主要终点为 ADR。高级别腺瘤定义为≥10mm、伴高级别异型增生或绒毛状形态。否则,腺瘤为非高级别。根据内镜医师的 ADR 和结肠清洁度对两组进行分层,评估 ADR。
结果:在意向治疗分析中,CADe 组的 ADR 为 55.1%(102/185),对照组为 43.8%(81/185)(P=0.029)。非高级别 ADR(54.8%比 40.8%,P=0.01)和扁平型 ADR(39.4%比 24.8%,P=0.006)、息肉检出率(67.1%比 51%,P=0.004)和每例结肠镜检查的腺瘤数量在 CADe 组显著高于对照组(中位数[25 分位数-75 分位数],1[0-2]比 0[0-1.5];P=0.014)。锯齿状 ADR 无显著差异。根据内镜医师和肠道清洁度分层后,ADR 无统计学差异。
结论:ENDO-AID(OIP-1)辅助结肠镜检查可提高 ADR 和每例结肠镜检查的腺瘤数量,提示其可能有助于发现结直肠肿瘤性病变,尤其是因为其可检测到微小和扁平的腺瘤。(临床试验注册号:NCT04945044.)
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