超声弹性成像在甲状腺结节诊断中的应用评价：ElaTION 随机对照试验。

Evaluation of US Elastography in Thyroid Nodule Diagnosis: The ElaTION Randomized Control Trial.

机构信息

From the Institute of Head and Neck Studies and Education (InHANSE), Institute of Cancer and Genomic Sciences (H.M., P.N., T.F.L.), Birmingham Clinical Trials Unit (R.W., A.P., J.T., J.D.), and Institute of Applied Health Research (K.B., A.P.), University of Birmingham, Robert Aitken Building, 2nd Floor, Birmingham, UK, B15 2TT; Department of Imaging Sciences, School of Biomedical Engineering and Imaging Sciences, King's College London, London, UK (P.S.S.); Department of Radiology, King's College Hospital NHS Foundation Trust, London, UK (P.S.S.); Department of Imaging, Imperial College Healthcare NHS Trust, St Mary's Hospital, London, UK (G.M.); Department of Pathology, University Hospitals Leicester, Leicester, UK (P.D.F., K.M.); Department of Head and Neck Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK (N.S.); Department of Radiology, Lister Hospital, Stevenage, UK (K.R.); Department of Radiology, Portsmouth Hospitals University NHS Trust, Portsmouth UK (J.B.); Department of Radiology, Leicester Royal Infirmary, Leicester, UK (R.V.); and Department of Radiology, Mid and South Essex NHS Foundation Trust, Basildon University Hospital, Basildon, UK (T.R.).

出版信息

Radiology. 2024 Oct;313(1):e240705. doi: 10.1148/radiol.240705.

DOI:10.1148/radiol.240705

PMID:39404634

Abstract

Background There is variable evidence and no randomized trials on the benefit of US elastography-guided fine-needle aspiration cytology (FNAC) over conventional US-guided FNAC alone for thyroid nodules. Purpose To compare the efficacy of US elastography-guided FNAC versus US-guided FNAC in reducing nondiagnostic rates for thyroid nodules. Materials and Methods A pragmatic, multicenter randomized controlled trial was performed at 18 secondary and tertiary hospitals across England between February 2015 and September 2018. Eligible adults with single or multiple thyroid nodules who had not previously undergone FNAC were randomized (1:1 ratio) to US elastography FNAC (intervention) or conventional US FNAC (control). The primary outcome was the proportion of patients who have a nondiagnostic cytologic Thy1 (British Thyroid Association system) result following the first FNAC. Results A total of 982 participants (mean age, 51.3 years ± 15 [SD] [IQR, 39-63]; male-to-female ratio, 1:4) were randomized. Of the 493 participants who underwent US elastography, 467 (94.7%) were examined with strain US elastography. There was no difference between the two arms in the nondiagnostic (Thy1) rate following the first FNAC (19% vs 16%; risk difference [RD], 0.03 [95% CI: -0.01, 0.07]; = .11) or in the median time to reach the final definitive diagnosis (3.3 months [IQR, 1.5-6.4] for US elastography FNAC vs 3.4 months [IQR, 1.5-6.2] for US FNAC). All sensitivity analyses supported the primary analysis. Fewer participants in the US elastography FNAC arm underwent diagnostic hemithyroidectomy than in the US FNAC arm (183 of 493 [37%] vs 196 of 489 [40%]), but this was not statistically significant (adjusted RD, 0.02 [95% CI: -0.06, 0.01]; = 0.15). There was no evidence of a difference in malignancy rates between the two arms: 70 of 493 (14%) in US elastography FNAC arm versus 79 of 489 (16%) in US FNAC arm ( = .39). There was also no difference in the rate of benign histologic findings between the groups (RD, -0.01 [95% CI: -0.04, 0.03]; = .7). Conclusion Strain US elastography does not appear to have additional benefit over conventional US FNAC in the diagnosis of malignancy in thyroid nodules. Clinical trial registration no. ISRCTN18261857 Published under a CC BY 4.0 license. See also the editorial by Isikbay and Harwin in this issue.

摘要

背景关于超声弹性成像引导下细针穿刺细胞学检查（FNAC）与传统超声引导下 FNAC 相比对甲状腺结节的益处，证据不一，且尚无随机试验。目的比较超声弹性成像引导下 FNAC 与超声引导下 FNAC 降低甲状腺结节非诊断率的效果。材料与方法 2015 年 2 月至 2018 年 9 月，在英格兰的 18 家二级和三级医院进行了一项务实的、多中心的随机对照试验。将未行 FNAC 的单发性或多发性甲状腺结节的合格成年患者按 1:1 的比例随机分为超声弹性成像 FNAC（干预组）或传统超声 FNAC（对照组）。主要结局是首次 FNAC 后出现非诊断性细胞学 Thy1（英国甲状腺协会系统）结果的患者比例。结果共纳入 982 名参与者（平均年龄 51.3 岁±15[SD] [IQR，39-63]；男：女，1:4）。在 493 名接受超声弹性成像检查的参与者中，有 467 名（94.7%）接受了应变超声弹性成像检查。两组首次 FNAC 后出现非诊断性（Thy1）结果的比例（19%比 16%；风险差 [RD]，0.03[95%CI：-0.01，0.07]； =.11）或达到最终明确诊断的中位时间（超声弹性成像 FNAC 为 3.3 个月 [IQR，1.5-6.4]，超声 FNAC 为 3.4 个月 [IQR，1.5-6.2]）均无差异。所有敏感性分析均支持主要分析结果。与超声 FNAC 组相比，超声弹性成像 FNAC 组行诊断性甲状腺叶切除术的患者较少（超声弹性成像 FNAC 组 183 例[37%]比超声 FNAC 组 196 例[40%]），但差异无统计学意义（调整 RD，0.02[95%CI：-0.06，0.01]； = 0.15）。两组间恶性肿瘤发生率无差异：超声弹性成像 FNAC 组 70 例（14%），超声 FNAC 组 79 例（16%）（ =.39）。两组间良性组织学发现率也无差异（RD，-0.01[95%CI：-0.04，0.03]； =.7）。结论与传统超声 FNAC 相比，应变超声弹性成像在甲状腺结节良恶性诊断中似乎没有额外获益。临床试验注册号 ISRCTN8261857 本文在知识共享署名 4.0 国际许可协议下发布，更多信息请参见本刊官网。本期还刊登了 Isikbay 和 Harwin 的相关述评。