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The American Society of Breast Surgeons.
Annals of Surgical Oncology

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A Randomized Prospective Study of Lumpectomy Margin Assessment with Use of MarginProbe in Patients with Nonpalpable Breast Malignancies

Freya Schnabel MD, Susan K. Boolbol MD, Mark Gittleman MD, Tami Karni MD, Lorraine Tafra MD, Sheldon Feldman MD, Alice Police MD, Neil B. Friedman MD, Scott Karlan MD, Dennis Holmes MD, Shawna C. Willey MD, Moshe Carmon MD, Kristen Fernandez MD, Stephanie Akbari MD, Jay Harness MD, Lisa Guerra MD, Thomas Frazier MD, Karen Lane MD, Rache M. Simmons MD, Alison Estabrook MD, Tanir Allweis MD
Breast Oncology
Volume 21, Issue 5 / May , 2014

Abstract

Background

The presence of tumor cells at the margins of breast lumpectomy specimens is associated with an increased risk of ipsilateral tumor recurrence. Twenty to 30 % of patients undergoing breast-conserving surgery require second procedures to achieve negative margins. This study evaluated the adjunctive use of the MarginProbe device (Dune Medical Devices Ltd, Caesarea, Israel) in providing real-time intraoperative assessment of lumpectomy margins.

Methods

This multicenter randomized trial enrolled patients with nonpalpable breast malignancies. The study evaluated MarginProbe use in addition to standard intraoperative methods for margin assessment. After specimen removal and inspection, patients were randomized to device or control arms. In the device arm, MarginProbe was used to examine the main lumpectomy specimens and direct additional excision of positive margins. Intraoperative imaging was used in both arms; no intraoperative pathology assessment was permitted.

Results

In total, 596 patients were enrolled. False-negative rates were 24.8 and 66.1 % and false-positive rates were 53.6 and 16.6 % in the device and control arms, respectively. All positive margins on positive main specimens were resected in 62 % (101 of 163) of cases in the device arm, versus 22 % (33 of 147) in the control arm (p < 0.001). A total of 19.8 % (59 of 298) of patients in the device arm underwent a reexcision procedure compared with 25.8 % (77 of 298) in the control arm (6 % absolute, 23 % relative reduction). The difference in tissue volume removed was not significant.

Conclusions

Adjunctive use of the MarginProbe device during breast-conserving surgery improved surgeons’ ability to identify and resect positive lumpectomy margins in the absence of intraoperative pathology assessment, reducing the number of patients requiring reexcision. MarginProbe may aid performance of breast-conserving surgery by reducing the burden of reexcision procedures for patients and the health care system.

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