A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery

Tanir M. Allweis, Zvi Kaufman, Shlomo Lelcuk, Itzhak Pappo, Tami Karni, Shlomo Schneebaum, Rona Spector, Asher Schindel, Dan Hershko, Moshe Zilberman, Joel Sayfan, Yuri Berlin, Amram Hadary, Oded Olsha, Haim Paran, Mordechai Gutman, Moshe Carmon

Research output: Contribution to journalArticlepeer-review

Abstract

Background: This randomized, double-arm trial was designed to study the benefit of a novel device (MarginProbe, Dune Medical Devices, Caesarea, Israel) in intraoperative margin assessment for breast-conserving surgery (BCS) and the associated reduction in reoperations. Methods: In the device group, the probe was applied to the lumpectomy specimen and additional tissue was excised according to device readings. Study arms were compared by reoperation rates and by correct surgical reaction confirmed by histology. Results: Three hundred patients were enrolled. Device use was associated with improved correct surgical reaction, defined as additional re-excision in all histologically detected positive margins, with tumor within 1 mm of inked margin. The repeat lumpectomy rate was significantly reduced by 56% in the device arm: 5.6% versus 12.7% in the control arm. There were no differences in excised tissue volume or cosmetic outcome. Conclusions: Intraoperative use of the MarginProbe for positive margin detection is safe and effective in BCS and decreases the rate of repeat operations.

Original languageEnglish
Pages (from-to)483-489
Number of pages7
JournalAmerican Journal of Surgery
Volume196
Issue number4
DOIs
StatePublished - Oct 2008
Externally publishedYes

Keywords

  • Breast cancer
  • Breast-conserving surgery
  • Intraoperative margin assessment
  • Lumpectomy
  • Positive margins
  • Surgical margins

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