A device for real-time, intraoperative margin assessment in breast-conservation surgery (BCS) of ductal carcinoma in situ (DCIS).

Abstract

e11080 Background: A sufficient margin assessment when excising a DCIS of the breast is difficult. Frozen section is unreliable and intraoperative radiography of the specimen gives only information about the size of the noticed lesion or the microcalcifications. This trial was conducted to study the benefit of a novel device (MarginProbe, Dune Medical Devices. Ltd.) in intraoperative margin assessment for BCS of DCIS and the associated reduction in reoperations. Methods: A multicenter, single arm study was conducted to determine the added benefit of the device use. The device was used as an adjunctive tool to the current practice. The surgeon received real time device output and reacted surgically intraoperatively. Based on the permanent histology report outcome, the added benefit of device use is demonstrated. Analyzed were the first 15 pts. enrolled in our institution (Sept. 2009–Jan. 2010). This preliminary analysis was done because of the excellent results. Results: Patients who benefit from MarginProbe were analyzed (8/15). Device use was associated with improved correct surgical reaction, defined as patients in which all histologically detected positive margins on the main specimen were identified by the device and resected intraoperatively. In 50 % (4/8, 50%) a repeat operation was avoided, in 2 pts. the device did not detect all positive margins (2/8, 25%) and two patients turned out to have invasive cancer (2/25%). Conclusions: Intraoperative use of the MarginProbe for positive margin detection is safe, fast and effective in BCS and decreases the rate of repeat operations by 50%. No significant financial relationships to disclose.