Kuon Yeng Escalante Cristina M, Siu Xiao Tania, Kono Yuko, Piscaglia Fabio, Wilson Stephanie R, Medellin Alexandra, Rodgers Shuchi K, Planz Virginia, Kamaya Aya, Fetzer David T, Berzigotti Annalisa, Sidhu Paul S, Wessner Corinne E, Bradigan Kristen, Eisenbrey John R, Forsberg Flemming, Lyshchik Andrej
Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
Medicine, Gastroenterology and Hepatology, University of California San Diego, San Diego, California, USA.
J Ultrasound Med. 2025 Feb;44(2):349-357. doi: 10.1002/jum.16608. Epub 2024 Oct 29.
Contrast-enhanced ultrasound (CEUS) Liver Imaging Reporting and Data System (LI-RADS) is used to definitively diagnose hepatocellular carcinoma (HCC) in patients at risk. However, the user variability associated with CEUS LI-RADS has not been validated in North American and European patients. This study aims to evaluate the inter-reader agreements of CEUS LI-RADS features for, and final categorization of, HCC in patients at risk.
This retrospective multicenter clinical study used the database of a previous prospective multinational study, evaluating the accuracy of CEUS LI-RADS for HCC diagnosis in patients at risk. All cases were first evaluated by a site physician performing/supervising the CEUS examination. Randomly selected cases were re-evaluated by a blinded central reader. Final diagnosis was confirmed with the reference standard, which was a composite of imaging tests and histology. Cohen's kappa test was used to evaluate inter-reader agreement.
This study included 150 liver nodules and 58.0% (87/150) were confirmed as HCC, 4.7% (7/150) non-HCC malignancies, 22.7% (34/150) had no confirmed final diagnosis, and 14.7% (22/150) were nonmalignant. Inter-reader agreements were substantial for CEUS LI-RADS categorization (κ = 0.61; 95% confidence interval [CI]: 0.51-0.71) and major features assessment (ranged κ = 0.64-0.78), LR-5 (κ = 0.65; 95% CI: 0.52-0.77), and LR-M (κ = 0.67; 95% CI: 0.44-0.90), while for LR-1 and LR-2 categorization was almost perfect (κ = 0.85; 95% CI: 0.65-1.00).
Our study reported a substantial inter-reader agreement for overall CEUS LI-RADS categorization, especially for LR-5 and LR-M, and major imaging features of HCC, further confirming CEUS LI-RADS as a valuable and reliable tool for diagnosis of HCC.
对比增强超声(CEUS)肝脏影像报告和数据系统(LI-RADS)用于对有风险的患者进行肝细胞癌(HCC)的明确诊断。然而,与CEUS LI-RADS相关的使用者变异性在北美和欧洲患者中尚未得到验证。本研究旨在评估有风险患者中CEUS LI-RADS特征对HCC的读者间一致性以及最终分类情况。
这项回顾性多中心临床研究使用了先前一项前瞻性跨国研究的数据库,评估CEUS LI-RADS对有风险患者HCC诊断的准确性。所有病例首先由进行/监督CEUS检查的现场医生进行评估。随机选择的病例由一位不知情的中心阅片者重新评估。最终诊断通过参考标准确认,该标准是影像学检查和组织学的综合结果。采用Cohen's kappa检验评估读者间的一致性。
本研究纳入了150个肝结节,其中58.0%(87/150)被确诊为HCC,4.7%(7/150)为非HCC恶性肿瘤,22.7%(34/150)未得到最终确诊,14.7%(22/150)为非恶性。读者间在CEUS LI-RADS分类(κ = 0.61;95%置信区间[CI]:0.51 - 0.71)、主要特征评估(κ范围为0.64 - 0.78)、LR-5(κ = 0.65;95% CI:0.52 - 0.77)和LR-M(κ = 0.67;95% CI:0.44 - 0.90)方面的一致性较高,而对于LR-1和LR-2分类几乎是完美的(κ = 0.85;95% CI:0.65 - 1.00)。
我们的研究报告了在CEUS LI-RADS总体分类方面读者间具有较高的一致性,尤其是对于LR-5和LR-M以及HCC的主要影像学特征,进一步证实了CEUS LI-RADS是诊断HCC的一种有价值且可靠的工具。