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甲状腺结节一线诊断方法中核心针活检的诊断效能和安全性:一项前瞻性队列研究。

Diagnostic Efficacy and Safety of Core Needle Biopsy as a First-Line Diagnostic Method for Thyroid Nodules: A Prospective Cohort Study.

机构信息

Department of Radiology, Chung-Ang University College of Medicine, Chung-Ang University Hospital, Seoul, Korea.

Department of Radiology, University of Ulsan College of Medicine, Gangneung Asan Hospital, Gangneung, Korea.

出版信息

Thyroid. 2020 Aug;30(8):1141-1149. doi: 10.1089/thy.2019.0444. Epub 2020 Apr 28.

DOI:10.1089/thy.2019.0444
PMID:32228167
Abstract

The diagnostic role of ultrasonography (US)-guided core needle biopsy (CNB) as a first-line diagnostic method for thyroid nodules remains controversial. This study was performed to determine the diagnostic efficacy and safety of CNB as a first-line diagnostic method for thyroid nodules. From February 2016 to January 2018, CNB was prospectively performed by an experienced radiologist in all consecutive patients with thyroid nodules indicated for fine-needle aspiration (FNA). Three patients refused this protocol. Finally, 212 consecutive patients with 248 thyroid nodules were enrolled in this prospective study. Combined CNB/FNA was selectively performed in 43 patients. The diagnostic efficacy of CNB was evaluated by the rate of inconclusive results (nondiagnostic or indeterminate results), and its feasibility was estimated by calculating the successful biopsy rate and by measuring the procedure time from the time of the initial skin puncture to the last withdrawal of the biopsy needle from the skin. The safety of the procedure was evaluated by the major and minor complication rates. A US evaluation was performed before and after manual self-compression to assess for hemorrhage at the biopsy site, and delayed complications were assessed 5-7 days after the biopsy. Any hemorrhage that did not require hospitalization was classified as a minor complication. CNB was performed once ( = 125, 50.4%), twice ( = 122, 49.2%), or three times ( = 1, 0.4%) per nodule. The diagnostic results of CNB were as follows: nondiagnostic (0.8%), benign (63.3%), indeterminate (10.1%), follicular neoplasm (3.2%), suspected malignancy (2.4%), and malignancy (20.1%); the rate of inconclusive results was 10.9%. The successful biopsy rate of CNB was 100%, and the median procedure time was 102 seconds (interquartile range 51-181 seconds). There were no major or delayed complications. There were 6 cases (2.8%) of minor complications, which included 2 cases (0.9%) with symptomatic hematomas and 4 cases (1.9%) with asymptomatic small hematomas. The findings confirm that CNB is effective in reducing the rate of inconclusive results and it is safe. CNB may be used as an alternative first-line diagnostic method for thyroid nodules by an experienced operator.

摘要

超声引导下细针穿刺活检(CNB)作为甲状腺结节的一线诊断方法的诊断作用仍存在争议。本研究旨在确定 CNB 作为甲状腺结节一线诊断方法的诊断效果和安全性。

从 2016 年 2 月至 2018 年 1 月,所有因细针抽吸(FNA)指征而接受甲状腺结节的经验丰富的放射科医生均前瞻性地进行 CNB。有 3 名患者拒绝该方案。最终,这项前瞻性研究共纳入了 212 例连续患者的 248 个甲状腺结节。43 例患者选择性地进行了 CNB/FNA 联合检查。通过无诊断结果(非诊断或不确定结果)的比例评估 CNB 的诊断效果,并通过计算成功活检率和从初始皮肤穿刺到最后从皮肤中抽出活检针的过程时间来评估其可行性。通过主要和次要并发症的发生率来评估该程序的安全性。在手动自我压缩前后进行 US 评估,以评估活检部位的出血情况,并在活检后 5-7 天评估迟发性并发症。无需住院治疗的任何出血均被归类为轻微并发症。

每个结节进行 1 次( = 125,50.4%)、2 次( = 122,49.2%)或 3 次( = 1,0.4%)CNB。CNB 的诊断结果如下:无诊断结果(0.8%)、良性(63.3%)、不确定(10.1%)、滤泡性肿瘤(3.2%)、疑似恶性(2.4%)和恶性(20.1%);无诊断结果的比例为 10.9%。CNB 的成功活检率为 100%,中位操作时间为 102 秒(四分位距 51-181 秒)。没有发生主要或迟发性并发症。有 6 例(2.8%)轻微并发症,包括 2 例(0.9%)有症状性血肿和 4 例(1.9%)无症状性小血肿。

这些发现证实 CNB 可有效降低无诊断结果的比例,且安全。经验丰富的操作者可将 CNB 作为甲状腺结节的一线诊断方法的替代方法。

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