在北美和欧洲进行的一项前瞻性多国研究中，对增强超声肝脏成像报告和数据系统进行了临床验证。
Clinical validation of contrast-enhanced ultrasound liver imaging reporting and data system in a prospective multinational study in North America and Europe.
发表日期：2023 Aug 08
作者：
Andrej Andrej Lyshchik, Corinne E Wessner, Kristen Bradigan, John R Eisenbrey, Flemming Forsberg, Misung Yi, Scott W Keith, Yuko Kono, Stephanie R Wilson, Alexandra Medellin, Shuchi K Rodgers, Virginia Planz, Aya Kamaya, Lisa Finch, David Fetzer, Annalisa Berzigotti, Paul S Sidhu, Fabio Piscaglia,
来源：
CLINICAL PHARMACOLOGY & THERAPEUTICS
摘要：
本研究旨在确定美国放射学学院增强超声造影（CEUS）肝脏成像报告和数据系统（LI-RADS）LR-5特征对北美或欧洲患者肝细胞癌（HCC）诊断的准确性。从2018年1月至2022年11月，在北美和欧洲的11个学术和非学术中心进行了前瞻性的多国籍队列研究。符合以下条件的患者均可参加研究：具有至少一个之前未经治疗的肝观察结果，该结果在标准临床护理的一部分，通过超声（US）或多相CT或MRI鉴定。所有参与者在进行CT / MRI或组织诊断后的4周内接受了肝脏CEUS检查，使用ACR CEUS LI-RADS对每个参与者的最多2个肝结节进行描述。通过初始CT / MRI，影像随访或CT / MRI不确定结节的组织学确诊作为参考标准。在480名患者的545个结节中，经确认参考标准，73.8％为HCC，5.5％为其他恶性病变，20.7％为非恶性病变。CEUS LR-5对HCC的特异度为95.1％（95％CI 90.1％-97.7％），敏感度为62.9％（95％CI 57.9％- 67.7％），阳性预测值（PPV）为97.3％（95％CI 94.5％-98.7％），阴性预测值（NPV）为47.7％（95％CI 41.7％-53.8％）。此外，良性CEUS表征（LR-1或LR-2）对非恶性肝结节的特异度和PPV均为100％。CEUS LI-RADS表征为HCC风险患者的肝结节提供了准确的分类。ClinicalTrials.gov ID NCT03318380.Copyright © 2023 American Association for the Study of Liver Diseases.
The objective of this study is to determine diagnostic accuracy of the American College of Radiology Contrast-Enhanced Ultrasound (CEUS) Liver Imaging Reporting and Data System (LI-RADS) LR-5 characterization for HCC diagnosis in North American or European patients.Prospective multinational cohort study was performed from 01/2018 through 11/2022 at 11 academic and nonacademic centers in North America and Europe. Patients at risk for HCC with at least one liver observation not previously treated, identified on ultrasound (US) or multiphase CT or MRI performed as a part of standard clinical care were eligible for the study. All participants were examined with CEUS of the liver within 4 weeks of CT / MRI or tissue diagnosis to characterize up to 2 liver nodules per participant using ACR CEUS LI-RADS. Definite HCC diagnosis on the initial CT/MRI, imaging follow-up, or histology for CT/MRI-indeterminate nodules were used as reference standard. A total 545 nodules had confirmed reference standard in 480 patients, 73.8% were HCC, 5.5% other malignancy, and 20.7% were non-malignant. The specificity of CEUS LR-5 for HCC was 95.1% (95% CI 90.1% - 97.7%), sensitivity 62.9% (95% CI 57.9%-67.7%), Positive Predictive Value (PPV) 97.3% (95% CI 94.5% - 98.7%), and Negative Predictive Value (NPV) 47.7% (95% CI 41.7% - 53.8%). In addition, benign CEUS characterization (LR-1 or LR-2) had 100% specificity and 100% PPV for non-malignant liver nodules.CEUS LI-RADS characterization provides accurate categorization of liver nodules in participants at risk for HCC. ClinicalTrials.gov ID NCT03318380.Copyright © 2023 American Association for the Study of Liver Diseases.