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MarginProbe®--德国保乳手术中导管原位癌的上市后研究的最终结果。

MarginProbe®--final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ.

机构信息

Department of Gynecology and Obstetrics, Agaplesion Markus Hospital, Germany.

Breast Cancer Center, Hospital Essen Mitte, Germany.

出版信息

Breast. 2014 Feb;23(1):94-6. doi: 10.1016/j.breast.2013.11.002. Epub 2013 Dec 2.

DOI:10.1016/j.breast.2013.11.002
PMID:24291375
Abstract

The goal in breast conserving surgery (BCS) of ductal carcinoma in situ (DCIS) is removal of the tumor with a clear surgical margin. However, re-excision rates are regrettably high. To date, there are no adequate procedures for intraoperative margin assessment of DCIS. A multicenter, single arm study was conducted to evaluate the benefit of a novel device (MarginProbe®) in intraoperative margin assessment during BCS of DCIS, the associated reduction of re-excisions and the cosmetic outcome of the treated patients. We present results of 42 patients enrolled in 3 German institutions. The device was used as an adjunctive tool to standard of care. The device use was associated with a reduction in re-excision rates by 56%, from 39% to 17% (p = 0.018).

摘要

保乳手术(BCS)治疗导管原位癌(DCIS)的目标是在保证切缘阴性的情况下彻底切除肿瘤。但遗憾的是,该术式的局部复发率仍较高。目前,针对 DCIS 术中切缘评估尚无明确有效的方法。本研究旨在评估 MarginProbe®在 DCIS 保乳术中评估切缘的有效性,及其降低局部复发率和改善美容效果的作用。该多中心、单臂研究共纳入了 3 家德国医疗机构的 42 名患者。该设备作为标准治疗的辅助工具使用。结果显示,与标准治疗相比,该设备可使局部复发率降低 56%,从 39%降至 17%(p = 0.018)。

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