title: A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery.
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.
authors.affiliation: Hadassah Hebrew University Medical Center, Jerusalem, Israel. Tanir@hadassah.org.il
authors.forename: Tanir M
authors.initials: TM
authors.lastname: Allweis
authors.forename: Zvi
authors.initials: Z
authors.lastname: Kaufman
authors.forename: Shlomo
authors.initials: S
authors.lastname: Lelcuk
authors.forename: Itzhak
authors.initials: I
authors.lastname: Pappo
authors.forename: Tami
authors.initials: T
authors.lastname: Karni
authors.forename: Shlomo
authors.initials: S
authors.lastname: Schneebaum
authors.forename: Rona
authors.initials: R
authors.lastname: Spector
authors.forename: Asher
authors.initials: A
authors.lastname: Schindel
authors.forename: Dan
authors.initials: D
authors.lastname: Hershko
authors.forename: Moshe
authors.initials: M
authors.lastname: Zilberman
authors.forename: Joel
authors.initials: J
authors.lastname: Sayfan
authors.forename: Yuri
authors.initials: Y
authors.lastname: Berlin
authors.forename: Amram
authors.initials: A
authors.lastname: Hadary
authors.forename: Oded
authors.initials: O
authors.lastname: Olsha
authors.forename: Haim
authors.initials: H
authors.lastname: Paran
authors.forename: Mordechai
authors.initials: M
authors.lastname: Gutman
authors.forename: Moshe
authors.initials: M
authors.lastname: Carmon
mesh_terms: D001943:Breast Neoplasms / Q000473:pathology* / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007430:Intraoperative Care / Q000295:instrumentation*; D015412:Mastectomy, Segmental / Q000295:instrumentation*; D008875:Middle Aged; D011446:Prospective Studies; D012086:Reoperation; D016896:Treatment Outcome