From the Department of Interventional Ultrasound, Fifth Medical Center of Chinese PLA General Hospital, No. 28 Fuxing Road, Haidian District, Beijing 100853, China (F.X., J.M.L., Z.Y.H., F.Y.L., J.Y., P.L.); Department of Cadet Corps, Chinese PLA Medical School, Beijing, China (F.X.); Department of Ultrasound Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (M.X.X.); Department of Ultrasound, Third Xiangya Hospital, Central South University, Hunan, China (P.Z.); Department of Ultrasound, Aero-space Center Hospital, Beijing, China (L.L.); Department of Ultrasound, Tianjin Medical University General Hospital, Tianjin, China (G.M.Z.); Department of Ultrasound, The First Affiliated Hospital of Dalian Medical University, Dalian, China (Y.C.); Department of Ultrasound, Yantai Hospital of Shandong Wendeng Orthopaedics & Traumatology, Yantai, China (S.R.W.); Department of Ultrasound, Jinan Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan, China (C.L.); and Department of Ultrasound, Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, China (Z.B.C.).
Radiology. 2023 Jun;307(5):e221408. doi: 10.1148/radiol.221408.
Background Current guidelines recommend the use of conventional US for risk stratification and management of thyroid nodules. However, fine-needle aspiration (FNA) is often recommended in benign nodules. Purpose To compare the diagnostic performance of multimodality US (including conventional US, strain elastography, and contrast-enhanced US [CEUS]) with the American College of Radiology Thyroid Imaging Reporting and Data System (TI-RADS) in the recommendation of FNA for thyroid nodules to reduce unnecessary biopsies. Materials and Methods In this prospective study, 445 consecutive participants with thyroid nodules from nine tertiary referral hospitals were recruited between October 2020 and May 2021. With univariable and multivariable logistic regression, the prediction models incorporating sonographic features, evaluated with interobserver agreement, were constructed and internally validated with bootstrap resampling technique. In addition, discrimination, calibration, and decision curve analysis were performed. Results A total of 434 thyroid nodules confirmed at pathologic analysis (259 malignant thyroid nodules) in 434 participants (mean age, 45 years ± 12 [SD]; 307 female participants) were included. Four multivariable models incorporated participant age, nodule features at US (proportion of cystic components, echogenicity, margin, shape, punctate echogenic foci), elastography features (stiffness), and CEUS features (blood volume). In recommending FNA in thyroid nodules, the highest area under the receiver operating characteristic curve (AUC) was 0.85 (95% CI: 0.81, 0.89) for the multimodality US model, and the lowest AUC was 0.63 (95% CI: 0.59, 0.68) for TI-RADS ( < .001). At the 50% risk threshold, 31% (95% CI: 26, 38) of FNA procedures could be avoided with multimodality US compared with 15% (95% CI: 12, 19) with TI-RADS ( < .001). Conclusion Multimodality US had better performance in recommending FNA to avoid unnecessary biopsies than the TI-RADS. Clinical trial registration no. NCT04574258 © RSNA, 2023
背景 当前指南建议使用常规超声(US)对甲状腺结节进行风险分层和管理。然而,在良性结节中通常推荐进行细针抽吸活检(FNA)。目的 比较多模态超声(包括常规 US、应变弹性成像和对比增强超声[CEUS])与美国放射学会甲状腺影像报告和数据系统(TI-RADS)在推荐甲状腺结节进行 FNA 以减少不必要的活检方面的诊断性能。
材料与方法 本前瞻性研究纳入了 2020 年 10 月至 2021 年 5 月期间来自 9 家三级转诊医院的 445 例连续甲状腺结节患者。采用单变量和多变量逻辑回归方法,构建了包含超声特征的预测模型,并采用自举重采样技术进行内部验证。此外,还进行了区分度、校准度和决策曲线分析。
结果 434 例(434 名参与者,平均年龄 45 岁±12[标准差];307 名女性)接受了病理分析证实的 434 个甲状腺结节(259 个恶性甲状腺结节)。4 个多变量模型纳入了参与者年龄、US 下的结节特征(囊性成分比例、回声、边缘、形状、点状回声焦点)、弹性成像特征(硬度)和 CEUS 特征(血流)。在推荐甲状腺结节进行 FNA 方面,多模态 US 模型的受试者工作特征曲线下面积(AUC)最高,为 0.85(95%置信区间:0.81,0.89),而 TI-RADS 的 AUC 最低,为 0.63(95%置信区间:0.59,0.68)(<.001)。在 50%风险阈值下,与 TI-RADS 相比,多模态 US 可避免 31%(95%置信区间:26,38)的 FNA 操作,而 TI-RADS 可避免 15%(95%置信区间:12,19)(<.001)。
结论 多模态 US 在推荐 FNA 以避免不必要的活检方面优于 TI-RADS。
临床试验注册号 NCT04574258
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