RESUMEN
BACKGROUND: Early diagnosis of malignant axillary nodes in breast cancer guides the extent of axillary surgery: patients with known axillary malignancy receive a more extensive single operation at the same time as surgery to their breast. A multicentre randomised controlled trial assessed whether a Computed Tomography (CT) scan of the axilla could more accurately diagnose malignant axillary lymph node involvement in patients with newly diagnosed breast cancer when compared to usual care. METHODS: Patients with newly diagnosed breast cancer (identified via screening and symptomatic pathways) at two NHS Trusts in the North East of England were recruited and randomised in equal numbers. Both groups received routine diagnostic and surgical care. In addition, one group received a CT scan of their axilla on the same side as the breast cancer. The primary endpoint was the need to undergo a second axillary surgical procedure. FINDINGS: The trial recruited 297 patients of whom 291 contributed to findings. The proportion of patients undergoing a second operation was similar (CT vs UC: 19.4% vs. 19.7%; CT-UC: -0.3%, 95%CI: = -9.5% to 8.9%, χ2 [1]: p = 1.00). Patients in the two groups were similar before treatment, had similar types and grade of cancer, experienced similar patterns of post-operative complications and reported similar experiences of care. INTERPRETATION: CT scan-guided care did not result in a change in the number of patients requiring a second operation; similar numbers of patients needed further axillary surgery in both groups. New diagnostic imaging technologies regularly enter NHS centres. It is important these are evaluated rigorously before becoming routine care.