基于气球的粘膜暴露装置在计算机辅助检测辅助结肠镜中的附加值:随机对照试验 (COMBAT研究)
Simone Rocchetto1,2, Emanuele Rondonotti1, Saverio Alicante3
1Gastroenterology Unit, Valduce Hospital, Como, Italy.
在结肠镜检查期间,将气球装置添加到计算机辅助检测 (CADe) 中并没有改善基于便免疫化学测试 (FIT) 的查中高风险发现的检测. 这表明单独的CADe可能足以进行最佳的腺瘤检测.
科学领域:
- 胃肠病学 胃肠病学
- 内镜检查是指内镜检查.
- 癌症查 癌症查
背景情况:
- 计算机辅助检测 (CADe) 和粘膜暴露设备可以在结肠镜检查期间加强腺瘤检测.
- 便免疫化学测试 (FIT) 是用于结直肠癌查的常见方法.
研究的目的:
- 评估是否将CADe系统与基于气球的粘膜暴露装置相结合,可以在基于FIT的查程序中增加高风险结肠镜检查结果的识别.
- 评估对腺瘤检测率 (ADR) 的影响.
主要方法:
- 进行了一项多中心,开放标签,并行臂随机对照试验.
- 具有FIT阳性的受试者被随机分配到使用气球装置的CADe辅助结肠镜或单独使用CADe辅助结肠镜.
- 主要终点是高风险发现率 (ESGE标准),次要终点是ADR.
主要成果:
- 在CADe+气球手臂 (19.3%) 和CADe手臂 (23.1%) (P=0.24) 的高风险发现中没有发现显著差异.
- 腺瘤检测率也相似:CADe+气球检测率为55.4%,CADe检测率为59.1% (P=0.32).
- 在研究期间没有报告任何不良事件.
结论:
- 在基于FIT的查计划中,在CADe辅助结肠镜检查中添加基于气球的粘膜暴露装置并没有改善高风险特征或瘤病变的检测.
- 潜在的CADe相关的上限效应可能会限制额外设备的好处.
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