Langhans Linnea, Tvedskov Tove F, Klausen Thomas L, Jensen Maj-Britt, Talman Maj-Lis, Vejborg Ilse, Benian Cemil, Roslind Anne, Hermansen Jonas, Oturai Peter S, Bentzon Niels, Kroman Niels
*Department of Plastic Surgery, Breast Surgery and Burns, Rigshospitalet, University of Copenhagen, Denmark †Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Denmark ‡Danish Breast Cancer Group, Rigshospitalet, University of Copenhagen, Denmark §Department of Pathology, Rigshospitalet, University of Copenhagen, Denmark ¶Department of Radiology, Rigshospitalet, University of Copenhagen, Denmark ||Department of Pathology, Herlev Hospital, University of Copenhagen, Denmark **Department of Clinical Physiology and Nuclear Medicine, Herlev Hospital, University of Copenhagen, Denmark ††Department of Breast Surgery, Herlev Hospital, University of Copenhagen, Denmark.
Ann Surg. 2017 Jul;266(1):29-35. doi: 10.1097/SLA.0000000000002101.
To compare the rate of positive resection margins between radioactive seed localization (RSL) and wire-guided localization (WGL) after breast conserving surgery (BCS).
WGL is the current standard for localization of nonpalpable breast lesions in BCS, but there are several difficulties related to the method.
From January 1, 2014 to February 4, 2016, patients with nonpalpable invasive breast cancer or DCIS visible on ultrasound were enrolled in this randomized, multicenter, open-label clinical trial, and randomly assigned to RSL or WGL. The primary outcome was margin status after BCS. Secondary outcomes were duration of the surgical procedure, weight of surgical specimen, and patients' pain perception. Analyses were performed by intention-to-treat (ITT) and per protocol.
Out of 444 eligible patients, 413 lesions representing 409 patients were randomized; 207 to RSL and 206 to WGL. Twenty-three did not meet inclusion criteria, chose to withdraw, or had a change in surgical management and were excluded. The remaining 390 lesions constituted the ITT population. Here, resection margins were positive in 23 cases (11.8%) in the RSL group compared with 26 cases (13.3%) in the WGL group (P = 0.65). The per-protocol analysis revealed no difference in margin status (P = 0.62). There were no significant differences in the duration of the surgical procedure (P = 0.12), weight of the surgical specimen (P = 0.54) or the patients' pain perception (P = 0.28).
RSL offers a major logistic advantage, as localization can be done several days before surgery without any increase in positive resection margins compared with WGL.
比较保乳手术（BCS）后放射性种子定位（RSL）与金属丝引导定位（WGL）的手术切缘阳性率。
WGL是目前BCS中不可触及乳腺病变定位的标准方法，但该方法存在一些困难。
2014年1月1日至2016年2月4日，将超声可见的不可触及浸润性乳腺癌或导管原位癌患者纳入这项随机、多中心、开放标签的临床试验，并随机分配至RSL组或WGL组。主要结局是BCS后的切缘状态。次要结局包括手术时间、手术标本重量和患者的疼痛感受。采用意向性分析（ITT）和符合方案分析。
444例符合条件的患者中，代表409例患者的413个病灶被随机分组；207个病灶分入RSL组，206个病灶分入WGL组。23例不符合纳入标准、选择退出或手术管理发生改变，被排除。其余390个病灶构成ITT人群。在此，RSL组23例（11.8%）手术切缘阳性，而WGL组为26例（13.3%）（P = 0.65）。符合方案分析显示切缘状态无差异（P = 0.62）。手术时间（P = 0.12）、手术标本重量（P = 0.54）或患者的疼痛感受（P = 0.28）均无显著差异。
RSL具有重要的后勤优势，因为与WGL相比，定位可在手术前数天进行，且手术切缘阳性率无任何增加。
