Department of Radiology, Catholic University of the Sacred Heart, Rome, Italy.
Department of Radiology, Catholic University of the Sacred Heart, Rome, Italy.
Clin Breast Cancer. 2017 Nov;17(7):536-543. doi: 10.1016/j.clbc.2017.02.008. Epub 2017 Mar 6.
The aim of the present study was to assess the diagnostic accuracy of ultrasound-guided core needle biopsy (US-CNB) of breast lesions, comparing smaller needles (16- and 18-gauge) with the 14-gauge needle, and to analyze the lesion characteristics influencing US-CNB diagnostic performance.
All the patients provided informed consent before the biopsy procedure. The data from breast lesions that had undergone US-CNB in our institution from January 2011 to January 2015 were retrospectively reviewed. The inclusion criterion was the surgical histopathologic examination findings of the entire lesion or radiologic follow-up data for ≥ 24 months. The exclusion criterion was the use of preoperative neoadjuvant therapy. The US-CNB results were compared with the surgical pathologic results or with the follow-up findings in the 3 needle size groups (14-, 16-, and 18-gauge). The needle size- and lesion characteristic-specific diagnostic accuracy parameters were evaluated. Statistical analysis was performed using a dedicated software program, and P ≤ .01 was considered significant.
A total of 1118 US-CNB cases (1042 patients) were included. Of the 1118 cases, 630 (56.3%) were in the 14-gauge group, 136 (12.2%) in the 16-gauge, and 352 (31.5%) in the 18-gauge needle group. Surgery was performed on 800 lesions (71.6%). Of these, 619 were malignant, 77 were high risk, and 104 were benign. The remaining 318 lesions (28.4%) underwent follow-up imaging studies. All the lesions were stable and, therefore, were considered benign. No differences were observed in the diagnostic accuracy parameters among the 3 needle size groups (P > .01). The false-negative rate was greater for lesions < 10 mm (7.2%) (P < .01) but without statistically significant differences among the 3 gauges (P > .01).
US-CNB performed with small needles (16 and 18 gauge) had the same diagnostic accuracy as that performed with 14-gauge needles, regardless of the lesion characteristics.
本研究旨在评估超声引导下核心针活检（US-CNB）对乳腺病变的诊断准确性，比较小直径（16-18 号）和 14 号针的诊断准确性，并分析影响 US-CNB 诊断性能的病变特征。
所有患者在活检前均签署知情同意书。回顾性分析 2011 年 1 月至 2015 年 1 月在我院接受 US-CNB 的乳腺病变患者的资料。纳入标准为：整个病变的手术组织病理学检查结果或放射学随访数据≥24 个月。排除标准为术前新辅助治疗。将 US-CNB 结果与手术病理结果或 3 种针径组（14、16 和 18 号）的随访结果进行比较。评估了针径和病变特征特异性诊断准确性参数。使用专用软件程序进行统计分析，P≤0.01 为有统计学意义。
共纳入 1118 例 US-CNB 病例（1042 例患者）。1118 例中，630 例（56.3%）为 14 号针组，136 例（12.2%）为 16 号针组，352 例（31.5%）为 18 号针组。800 例病变进行了手术（71.6%）。其中 619 例为恶性病变，77 例为高危病变，104 例为良性病变。其余 318 例病变（28.4%）进行了随访影像学检查。所有病变均稳定，因此被认为是良性的。3 种针径组的诊断准确性参数无差异（P＞0.01）。<10mm 的病变假阴性率较高（7.2%）（P＜0.01），但 3 种针径之间无统计学差异（P＞0.01）。
使用小直径（16 和 18 号）的 US-CNB 具有与 14 号针相同的诊断准确性，与病变特征无关。
