Further surgery following BCS is required in 25% of patients with invasive cancers and associated DCIS, and up to 30% of patients due to disease found at the edge of the tissue removed. There is an urgent need to reduce the re-operation rate for the benefit of both patients and the NHS. The MarginProbe is a disposable CE-marked device which measures the margins of tissue excised at the time of BCS (namely margins of <1mm width which includes both positive margins and ‘no tumour at ink’). This allows surgeons to perform cavity re-excisions at the time of initial surgery and avoids re-operation. This study will randomise 460 patients from six specialist breast units to either MarginProbe assessment of the surgical specimen with re-excision if required or standard BCS (clinically and radiologically clear margins) in which the wound will be closed and surgery completed (cavity shave may be performed based on specimen X-ray).
The primary aim of the study is to determine whether the MarginProbe device reduces the need for a second surgical procedure and improves margin clearance (at least a 1mm circumferential margin) by enabling removal of involved margins during the same procedure. The main outcome measure will be the number of patients requiring second re-excision surgery within nine months of their first BCS procedure. The study will compare the number of patients in both groups with excision margins greater than 1mm after BCS on histopathological evaluation. The study will also address quality of life and cosmetic outcomes and health related quality of life and cosmetic appearance will be assessed by individuals who are blinded to the use of MarginProbe. This study will potentially identify and validate a cost-effective and new technology which can reduce NHS costs, reduce the number of re-excisions and benefit patients.
- Women aged 18 - 90 years with DCIS or invasive breast cancer containing DCIS diagnosed histopathologically
- Histologically diagnosed DCIS or invasive ductal or lobular cancer on core biopsy (B5a or B5b)
- Tumour size 1.5cm 4cm and undergoing breast conserving surgery
- Written informed consent
Contact information will be available in due course.