Breast Radiology Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
Department of Cardiac Thoracic Vascular Sciences and Public Health, Unit of Biostatistics, Epidemiology and Public Health, University of Padova, Padova, Italy.
Breast. 2021 Aug;58:93-105. doi: 10.1016/j.breast.2021.04.007. Epub 2021 Apr 22.
Pre-operative localization of non-palpable breast lesions with non-wired non-ionizing (NWNI) techniques may improve clinical outcomes as reoperation rate, cosmetic outcome and contribute to organizational aspects improvement in breast-conserving surgery (BCS). However only limited literature is available and clinical studies involving these forefront devices are often small and non-randomized. Furthermore, there is a lack of consensus on free margins and cosmetic outcomes definitions. The objective of the present meta-analysis was to determine the crude clinical outcomes reported for the NWNI techniques on BCS. A literature search was performed of PubMed, Embase and Scopus databases up to February 2021 in order to select all prospective or retrospective clinical trials on pre-operative breast lesion localization done with NWNI devices. All studies were assessed following the PRISMA recommendations. Continuous outcomes were described in averages corrected for sample size, while binomial outcomes were described using the weighted average proportion. Twenty-seven studies with a total of 2103 procedures were identified. The technique is consolidated, showing for both reflectors' positioning and localization nearly the 100% rate of success. The re-excision and clear margins rates were 14% (95% CI, 11-17%) and 87% (80-92%), respectively. Overall, positive margins rates were 12% (8-17%). In studies that compared NWNI and wire localization techniques, positive margin rate is lower for the first techniques (12%, 6-22% vs 17%, 12-23%) and re-excision rate is slightly higher using the latter (13%, 9-19% vs 16%, 13-18%). Pre-operative NWNI techniques are effective in the localization of non-palpable breast lesions and are promising in obtaining clear (or negative) margins minimizing the need for re-excision and improving the cosmetic outcomes. Randomized trials are needed to confirm these findings.
术前应用无导丝非电离（NWNI）技术定位不可触及的乳腺病变可能会改善临床结果，降低再次手术率和改善美容效果，并有助于提高保乳手术（BCS）的组织学方面。然而，目前仅有有限的文献可用，涉及这些前沿设备的临床研究通常规模较小且是非随机的。此外，游离切缘和美容效果的定义尚缺乏共识。本荟萃分析的目的是确定 NWNI 技术在 BCS 中的临床结果。通过检索 PubMed、Embase 和 Scopus 数据库，对截至 2021 年 2 月的所有关于 NWNI 设备进行术前乳腺病变定位的前瞻性或回顾性临床试验进行了文献检索。所有研究均按照 PRISMA 建议进行评估。连续变量的结果以经样本量校正的平均值表示，而二项式变量的结果以加权平均比例表示。共确定了 27 项研究，共 2103 例手术。该技术已经成熟，定位反射器的成功率接近 100%。再次切除和切缘清晰的比例分别为 14%（95%CI，11-17%）和 87%（80-92%）。总体而言，阳性切缘率为 12%（8-17%）。在比较 NWNI 和导丝定位技术的研究中，前者的阳性切缘率较低（12%，6-22%比 17%，12-23%），而后者的再次切除率略高（13%，9-19%比 16%，13-18%）。术前 NWNI 技术在定位不可触及的乳腺病变方面是有效的，并有望获得清晰（或阴性）的切缘，从而最大限度地减少再次切除的需要，改善美容效果。需要进行随机试验来证实这些发现。
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