Does Intra-operative MarginProbe Use Reduce Re-excision Rates?

Almost 60% of all patients diagnosed with breast cancer (48000 annually in the UK) undergo breast conserving surgery (BCS. Surgical removal of the cancer aims to reduce the risk of local recurrence and patient mortality. In order to minimise the amount of tissue removed, excision up to the cancer-free area (margins) is undertaken. Further surgery, following initial breast cancer surgery, is required in 25% - 30% of patients because of disease found at the edges of the tissue removed.

Reducing the need for further operations benefits patients (by reducing the number of operations required, improving cosmetic outcome and minimising anxiety) and the NHS (by realising economic benefits).

MarginProbe, a disposable probe which measures the margins of tissue removed during breast cancer surgery, allows the surgeon to remove further tissue during the same surgical procedure to clear any involved margins, minimising subsequent re-operations. Four hundred and sixty patients in 6 specialist Breast Units will be randomly allocated after BCS (and specimen radiology), by telephone randomisation, to either:

• MarginProbe assessment of the surgical specimen with re-excision of margins if required;
• Standard BCS (clinical and radiological clear margins) whereby the wound will be closed and the surgery completed (standard UK practice).

Inclusion criteria

;

• Women aged 18-90 years with DCIS or Invasive Breast cancer containing DCIS diagnosed histopathologically.
• Histologically diagnosed DCIS or invasive lobular cancer in core biopsy (B5a or B5b).
• Tumour size 1.5cm - 4cm and undergoing breast cancer surgery. Written informed consent.

Exclusion criteria

;

• Unsuitable for BCS on basis of tumour size (<1.5cm or >4cm) or stage.
• Radiotherapy contraindicated.
• No histopathological evidence of DCIS or invasive lobular cancer.
• Neoadjuvant chemotherapy.