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.
RCT Entities:
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: Jane J Keating; Jeffrey J Runge; Sunil Singhal; Sarah Nims; Ollin Venegas; Amy C Durham; Gary Swain; Shuming Nie; Philip S Low; David E Holt Journal: Cancer Date: 2016-11-07 Impact factor: 6.860
Authors: Barbara L Smith; Michele A Gadd; Conor R Lanahan; Upahvan Rai; Rong Tang; Travis Rice-Stitt; Andrea L Merrill; David B Strasfeld; Jorge M Ferrer; Elena F Brachtel; Michelle C Specht Journal: Breast Cancer Res Treat Date: 2018-06-09 Impact factor: 4.872
Authors: Anees B Chagpar; Nina R Horowitz; Brigid K Killelea; Theodore Tsangaris; Peter Longley; Sonia Grizzle; Michael Loftus; Fangyong Li; Meghan Butler; Karen Stavris; Xiaopan Yao; Malini Harigopal; Veerle Bossuyt; Donald R Lannin; Lajos Pusztai; Amy J Davidoff; Cary P Gross Journal: Ann Surg Date: 2017-01 Impact factor: 12.969
Authors: Rick G Pleijhuis; Maurits Graafland; Jakob de Vries; Joost Bart; Johannes S de Jong; Gooitzen M van Dam Journal: Ann Surg Oncol Date: 2009-07-17 Impact factor: 5.344