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

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

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).

Keywords: Breast conservation surgery; Ductal carcinoma in situ; Intraoperative margin assessment; Radiofrequency spectroscopy; Surgical margins.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Breast Neoplasms / pathology
  • Breast Neoplasms / surgery*
  • Carcinoma, Intraductal, Noninfiltrating / pathology
  • Carcinoma, Intraductal, Noninfiltrating / surgery*
  • Cohort Studies
  • Female
  • Germany
  • Humans
  • Intraoperative Care
  • Mastectomy, Segmental / instrumentation*
  • Neoplasm Recurrence, Local / prevention & control*
  • Patient Satisfaction
  • Product Surveillance, Postmarketing
  • Reoperation
  • Spectrum Analysis / instrumentation