Eltoum Noon, Zamora Kathryn, Murray Adrian, West John, Willis Joseph, Chieh Angela, Li Yufeng, Li Mei, Park Jeong Mi, Woodard Stefanie
Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
J Breast Imaging. 2024 Nov 5;6(6):610-620. doi: 10.1093/jbi/wbae050.
Inaccurate breast biopsy marker placement and marker migration during stereotactic biopsy procedures compromise their reliability for lesion localization and precise surgical excision. This trial evaluated the impact of 5-mm predeployment retraction of the marker introducer on marker migration, investigating other potential factors that influence the outcome.
This parallel, randomized controlled trial enrolled women aged ≥18 years undergoing stereotactic breast biopsy at a single institution from May 2020 through August 2022. The study was approved by the institutional review board at the University of Alabama at Birmingham (UAB). Patients were randomized to intervention (5-mm introducer retraction before marker deployment) or control (standard marker placement) by drawing a labeled paper. The primary outcome was the distance of marker migration on immediate postprocedure mammogram.
Of 251 patients enrolled, 223 were analyzed; 104 received the intervention, and 119 received control. Mean (SD) marker migration was 12.1 (14.9) mm in the intervention group vs 9.8 (14.9) mm, with differences between groups estimated at 2.3 mm (SE = 1.9, P = .2312) (d = 0.16; 95% CI, 1.5-6.0). Effects of age, breast density, thickness, and biopsy approach showed no statistical significance. In exploratory models, central lesions exhibited 5.7 mm less migration than proximal lesions (95% CI, 0.7-10.6; P = .025), and each body mass index (BMI) unit increase was associated with 0.3 mm greater migration (95% CI, 0-0.6; P = .044).
Retracting the marker introducer 5 mm before deployment did not reduce migration. Higher BMI and certain lesion locations were all associated with marker migration, highlighting the need to investigate biomechanical factors and techniques to optimize breast marker placement.Clinical Trials Registration: NCT04398537.
在立体定向活检过程中，乳腺活检标记物放置不准确以及标记物移位会影响其在病变定位和精确手术切除中的可靠性。本试验评估了标记物导入器预部署5毫米回缩对标记物移位的影响，并研究了其他影响结果的潜在因素。
这项平行随机对照试验纳入了2020年5月至2022年8月在单一机构接受立体定向乳腺活检的18岁及以上女性。该研究得到了阿拉巴马大学伯明翰分校（UAB）机构审查委员会的批准。通过抽取有标签的纸张，将患者随机分为干预组（标记物部署前导入器回缩5毫米）或对照组（标准标记物放置）。主要结局是术后即刻乳房X线摄影中标记物的移位距离。
在纳入的251例患者中，对223例进行了分析；104例接受干预，119例接受对照。干预组标记物平均（标准差）移位为12.1（14.9）毫米，对照组为9.8（14.9）毫米，组间差异估计为2.3毫米（标准误=1.9，P=0.2312）（d=0.16；95%置信区间，1.5-6.0）。年龄、乳腺密度、厚度和活检方法的影响无统计学意义。在探索性模型中，中央病变的移位比近端病变少5.7毫米（95%置信区间，0.7-10.6；P=0.025），体重指数（BMI）每增加一个单位，移位增加0.3毫米（95%置信区间，0-0.6；P=0.044）。
部署前将标记物导入器回缩5毫米并不能减少移位。较高的BMI和某些病变位置均与标记物移位有关，这突出表明需要研究生物力学因素和技术以优化乳腺标记物的放置。临床试验注册：NCT04398537。
