Does the use of an Intraoperative device to assess margins reduce need for reexcison after breast conserving surgery: Multicentre Randomised Controlled Trial

Abstract

Background: The ABS audit of 17,045 cancers indicates that re-excision is required in 20% of invasive cancers and up to 30% of non-invasive DCIS to clear margins after Breast Conservation(BCS). A further 8% of patients undergo a third procedure to convert to a mastectomy. Reducing the need for further operations benefits patients. To determine if the use of the MarginProbe, a CE device on the removed surgical specimen margin, (after tumour excision and tissue specimen radiography of a breast cancer (with surrounding ductal carcinoma in situ [DCIS]) or DCIS) reduces rates of surgical re-excision operations, when compared to standard practice. we performed a multicentre UK randomised controlled trial. We aimed to compare the total number of re-excision procedures required following BCS because of positive margins less than 1 mm (circumferentially) and the number of patients presenting with excision margins greater than 1 mm circumferentially clear after BCS, judged by histopathological assessment. Additionally we determined Quality of life and health related facility measures (EQ5D) between patient groups. The Trial randomised women aged 18 to 90 years, with early cancer larger than 1.5 cm (invasive breast cancer with surrounding DCIS or DCIS alone, histologically diagnosed by core biopsy), scheduled to undergo BCS. All 10 UK centres agreed the protocol and were proctored (trained in the use of the device) for their first 5 cases. Results: In total 467 patients were randomised by block allocation, 242 underwent marginprobe assessment intraoperatively and 225 no probe assessment (control). Seventyeight patients required a repeat lumpectomy/excision within 9 months (40 MarginProbe & 38 Control). DCIS, rexcision rate was 20.5% and Invasive cancer was 13.5%.Re-excision rates did not differ between the groups (39/94 = 41.5% MarginProbe & 35/89 = 39.3% Control patients with closest margin width <1 mm had re-excision within 9 months). However 0.7% MarginProbe & 2.2% Control patients with closest margin width >1 mm had re-excision within 9 months. Rexcision rate in the Marginprobe arm varied across centres from 6.5 to 33.3% (Highest Centre rexcision rate vs lowest centre p = 0.0029) and controls from 7.5%–45%. There was no difference in the tissue weight excised between the treatment groups. Neither Body Image or Sexual Adjustment sub-scales at 9 months differed between the treatment groups, after adjusting for baseline scores FACT-B TOI Quality of Life scores between patients who had re-excision & those that didn’t differ, at any of the follow-up time points (1,3,9 months). Conclusion: Due to variation in margin clearance between centres, no effect of marginprobe device use on clearance was identified. Although the idea of intraoperative testing of margins to prevent recurrence appealed to patients, device use did not impact outcomes.