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期刊来源：Ann Intern Med

原文链接：https://doi.org/10.7326/M24-0086

摘要内容如下：

背景

实时预测结直肠小息肉的组织学特征可以避免切除和/或病理评估，从而降低结肠镜检查的费用。先前的研究表明，计算机辅助诊断（CADx）是高度准确的，尽管它并没有超过专家内镜医师。

客观

在真实环境中，评估普通内镜医师在CADx辅助前后组织学预测的诊断性能。

设计

前瞻性、多中心、单组研究。（ClinicalTrials.gov：NCT04437615）

设置

全美6个中心。

参与者

1252名接受结肠镜检查的连续患者和49名在实时预测息肉组织学特征方面具有不同经验的普通内镜医师。

干预

在常规结肠镜检查中实时使用CADx。

测量

主要终点是无CADx辅助和CADx辅助的组织学预测5 mm或更小的腺瘤的敏感性和特异性。出于临床目的，根据位置和置信水平提供了额外的估计值。

结果

在1252名患者中，CADx设备诊断了2695个5 mm或更小的息肉（96%）。无辅助组和辅助组之间的敏感性没有差异（90.7%vs.90.8%；P=0.52）。CADx辅助组的特异性更高（59.5%vs.64.7%；P<0.001）。在所有2695个5mm或更小的息肉中，在CADx辅助组和非辅助组中分别有88.2%和86.1%（P<0.001）可以在没有病理评估的情况下切除和丢弃。在743个直径小于等于5 mm的直肠乙状结肠息肉中，有49.5%（CADx辅助组）和47.9%（无辅助组）的息肉可以原位保留而不切除（P<0.001）。

局限性

在临床试验之外，基于CADx的决策可能有所不同。

结论

CADx辅助并未导致光学诊断的敏感性增加。尽管有轻微的增加，但CADx辅助诊断的特异性仍然不理想。

主要资金来源

奥林巴斯美国公司担任临床研究赞助商。

英文原文如下：

Abstracts

BACKGROUND  Real-time prediction of histologic features of small colorectal polyps may prevent resection and/or pathologic evaluation and therefore decrease colonoscopy costs. Previous studies showed that computer-aided diagnosis (CADx) was highly accurate, though it did not outperform expert endoscopists.

OBJECTIVE  To assess the diagnostic performance of histologic predictions by general endoscopists before and after assistance from CADx in a real-life setting.

DESIGN  Prospective, multicenter, single-group study. (ClinicalTrials.gov: NCT04437615).

SETTING  6 centers across the United States.

PARTICIPANTS  1252 consecutive patients undergoing colonoscopy and 49 general endoscopists with variable experience in real-time prediction of polyp histologic features.

INTERVENTION  Real-time use of CADx during routine colonoscopy.

MEASUREMENTS  The primary end points were the sensitivity and specificity of CADx-unassisted and CADx-assisted histologic predictions for adenomas measuring 5 mm or less. For clinical purposes, additional estimates according to location and confidence level were provided.

RESULTS  The CADx device made a diagnosis for 2695 polyps measuring 5 mm or less (96%) in 1252 patients. There was no difference in sensitivity between the unassisted and assisted groups (90.7% vs. 90.8%; P = 0.52). Specificity was higher in the CADx-assisted group (59.5% vs. 64.7%; P < 0.001). Among all 2695 polyps measuring 5 mm or less, 88.2% and 86.1% (P < 0.001) in the CADx-assisted and unassisted groups, respectively, could be resected and discarded without pathologic evaluation. Among 743 rectosigmoid polyps measuring 5 mm or less, 49.5% and 47.9% (P < 0.001) in the CADx-assisted and unassisted groups, respectively, could be left in situ without resection.

LIMITATION  Decision making based on CADx might differ outside a clinical trial.

CONCLUSION  CADx assistance did not result in increased sensitivity of optical diagnosis. Despite a slight increase, the specificity of CADx-assisted diagnosis remained suboptimal.

PRIMARY FUNDING SOURCE  Olympus America Corporation served as the clinical study sponsor.

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