Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; Endoscopy Unit, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.
Endoscopy Unit, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy.
Lancet Gastroenterol Hepatol. 2024 Nov;9(11):1010-1019. doi: 10.1016/S2468-1253(24)00222-X. Epub 2024 Sep 17.
The resect-and-discard strategy allows endoscopists to replace post-polypectomy pathology with real-time prediction of polyp histology during colonoscopy (optical diagnosis). We aimed to investigate the benefits and harms of implementing computer-aided diagnosis (CADx) for polyp pathology into the resect-and-discard strategy.
In this systematic review and meta-analysis, we searched MEDLINE, Embase, and Scopus from database inception to June 5, 2024, without language restrictions, for diagnostic accuracy studies that assessed the performance of real-time CADx systems, compared with histology, for the optical diagnosis of diminutive polyps (≤5 mm) in the entire colon. We synthesised data for three strategies: CADx-alone, CADx-unassisted, and CADx-assisted; when the endoscopist was involved in the optical diagnosis, we synthesised data exclusively from diagnoses for which confidence in the prediction was reported as high. The primary outcomes were the proportion of polyps that would have avoided pathological assessment (ie, the proportion optically diagnosed with high confidence; main benefit) and the proportion of polyps incorrectly predicted due to false positives and false negatives (main harm), directly compared between CADx-assisted and CADx-unassisted strategies. We used DerSimonian and Laird's random-effects model to calculate all outcomes. We used Higgins I to assess heterogeneity, the Grading of Recommendations, Assessment, Development, and Evaluation approach to rate certainty, and funnel plots and Egger's test to examine publication bias. This study is registered with PROSPERO, CRD42024508440.
We found 1019 studies, of which 11 (7400 diminutive polyps, 3769 patients, and 185 endoscopists) were included in the final meta-analysis. Three studies (1817 patients and 4086 polyps [2148 neoplastic and 1938 non-neoplastic]) provided data to directly compare the primary outcome measures between the CADx-unassisted and CADx-assisted strategies. We found no significant difference between the CADx-assisted and CADx-unassisted strategies for the proportion of polyps that would have avoided pathological assessment (90% [88-93], 3653 [89·4%] of 4086 polyps diagnosed with high confidence vs 90% [95% CI 85-94], 3588 [87·8%] of 4086 polyps diagnosed with high confidence; risk ratio 1·01 [95% CI 0·99-1·04; I=53·49%; low-certainty evidence; Egger's test p=0·18). The proportion of incorrectly predicted polyps was lower with the CADx-assisted strategy than with the CADx-unassisted strategy (12% [95% CI 7-17], 523 [14·3%] of 3653 polyps incorrectly predicted with a CADx-assisted strategy vs 13% [6-20], 582 [16·2%] of 3588 polyps incorrectly diagnosed with a CADx-unassisted strategy; risk ratio 0·88 [95% CI 0·79-0·98]; I=0·00%; low-certainty evidence; Egger's test p=0·18).
CADx did not produce benefit nor harm for the resect-and-discard strategy, questioning its value in clinical practice. Improving the accuracy and explainability of CADx is desired.
European Commission (Horizon Europe), the Japan Society of Promotion of Science, and Associazione Italiana per la Ricerca sul Cancro.
切除并丢弃策略允许内镜医生在结肠镜检查（光学诊断）期间用息肉组织学的实时预测来替代息肉切除后的病理检查。我们旨在研究将计算机辅助诊断（CADx）应用于息肉病理纳入切除并丢弃策略的益处和危害。
在这项系统评价和荟萃分析中，我们检索了 MEDLINE、Embase 和 Scopus 数据库，检索时间截至 2024 年 6 月 5 日，无语言限制，以评估实时 CADx 系统的性能，该系统用于整个结肠的微小息肉（≤5mm）的光学诊断，并与组织学进行比较。我们综合了三种策略的数据：CADx-单独、CADx-非辅助和 CADx-辅助；当内镜医生参与光学诊断时，我们仅综合了报告对预测有信心的诊断数据。主要结局是避免病理评估的息肉比例（即光学诊断为高可信度的息肉比例；主要益处）和由于假阳性和假阴性而错误预测的息肉比例（主要危害），直接比较 CADx-辅助和 CADx-非辅助策略之间的差异。我们使用 DerSimonian 和 Laird 的随机效应模型计算所有结局。我们使用 Higgins I 评估异质性，使用 Grading of Recommendations, Assessment, Development, and Evaluation 方法评估确定性，并使用漏斗图和 Egger 检验检查发表偏倚。本研究在 PROSPERO 注册，CRD42024508440。
我们发现了 1019 项研究，其中 11 项（7400 个微小息肉，3769 名患者和 185 名内镜医生）纳入最终的荟萃分析。三项研究（1817 名患者和 4086 个息肉[2148 个肿瘤性和 1938 个非肿瘤性]）提供了数据，可直接比较 CADx-非辅助和 CADx-辅助策略之间的主要结局指标。我们没有发现 CADx-辅助和 CADx-非辅助策略之间在避免病理评估的息肉比例方面有显著差异（90%[88-93]，4086 个息肉中有 3653 个诊断为高可信度 vs 90%[95%CI 85-94]，4086 个息肉中有 3588 个诊断为高可信度；风险比 1.01[95%CI 0.99-1.04；I=53.49%；低确定性证据；Egger 检验 p=0.18]）。CADx-辅助策略的错误预测息肉比例低于 CADx-非辅助策略（12%[95%CI 7-17]，3653 个息肉中有 523 个预测错误的 CADx-辅助策略 vs 13%[6-20]，3588 个息肉中有 582 个预测错误的 CADx-非辅助策略；风险比 0.88[95%CI 0.79-0.98]；I=0.00%；低确定性证据；Egger 检验 p=0.18）。
CADx 既没有给切除并丢弃策略带来益处，也没有带来危害，这对其在临床实践中的应用提出了质疑。希望提高 CADx 的准确性和可解释性。
欧洲委员会（地平线欧洲）、日本学术振兴会和意大利癌症研究协会。
