人工智能辅助的光学诊断在结肠镜检查期间留下直肠多的安全性 (PRACTICE):一种非劣势的随机对照试验
Giulio Antonelli1, Federico Desideri2, Patrizio Scarozza1
1Gastroenterology and Digestive Endoscopy Unit, Ospedale dei Castelli Hospital, Rome, Italy.
The lancet. Gastroenterology & hepatology
|September 6, 2025
概括
在结肠镜检查期间留下小的,非新发性直筒状息肉与切除所有息肉一样安全. 通过计算机诊断的帮助,这种策略可以减少不必要的手术,而不会影响腺瘤检测率.
科学领域:
- 胃肠病学和内镜
- 癌症学
- 临床试验
背景情况:
- 目前的指导方针建议在结肠镜检查过程中,如果光学预测为非新生体,则在现场留下小 (≤5毫米) 的直指性息肉.
- 这种"留在现场"策略的有效性和安全性尚未通过随机对照试验进行严格评估.
- 计算机辅助检测和诊断系统越来越多地用于帮助内镜医生进行多体表征.
研究的目的:
- 确定光学诊断的非新发性息肉的"留在现场"策略是否与腺瘤检测率 (ADR) 的"切除全部"策略不劣.
- 在随机对照试验中评估"留在现场"方法的瘤安全性.
- 评估计算机辅助光学诊断对聚管理决策的影响.
主要方法:
- 一个开放的,多中心的,非劣势的随机对照试验 (NCT05500248) 涉及895名接受结肠镜检查的成年患者.
- 患者被随机分为1:1的"留在原位"组 (留在原位的非新发性息肉) 或"切除全部"组 (切除所有息肉).
- 光学诊断由白光,蓝光和计算机辅助检测和诊断系统支持;病理学家和调查人员被掩盖为组分配.
主要成果:
- 腺瘤检测率 (ADR) 在"留在现场"组为44. 7%,在"切除全部"组为46. 5% (绝对差异为-1. 8%,95% CI为- 8. 9至4. 9;p非劣势=0. 013),符合非劣势差.
- 两种策略之间没有明显的不良反应差异,这表明"留在现场"的方法不劣.
- 在两组中都没有报告透或出血等结肠镜相关并发症,这表明安全性概况相似.
结论:
- 通过计算机辅助系统支持的光学诊断的"留在现场"策略是ADR测量的瘤安全性.
- 与系统的"切除所有"策略相比,这种方法不会影响腺瘤的检测.
- "留在现场"的策略可以减少不必要的多角切除术,使其成为结肠镜实践的有吸引力的选择.
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