Abstract P1-01-01: Learning Sentinel Node Biopsy in the UK: Results of the NEW START Training Program

Abstract

Background: NEW START-a structured, validated multi-professional surgical training programme, was established to allow rapid transfer of appropriate knowledge and technical skills to ensure safe and competent practice of sentinel lymph node biopsy (SLNB) across the UK. Methods: Multi-professional teams attended a theory/skills-lab course delivering a standardized educational package, following which they performed SLNB in 30 consecutive patients, either concurrently with their standard axillary staging procedure — mentorship training model-or as stand-alone SLNB — apprenticeship training model. An accredited NEW START trainer mentored the first 5 procedures in the participants’ hospital, or all 30 if stand-alone. Validation standards were a localization rate of ≥90% and in the mentorship program where a minimum of 10 cases were node positive, a false-negative rate of ≥10%. SLNB was performed according to a standardised protocol using the combined technique of isotope (0.05-0.1ml of 99mTc-albumin colloid — Nanocoll®) and blue dye (Patent blue V) injected into the tumour quadrant peri-areolar tissue. Isotope was injected intra-dermally and static scintigraphic images were obtained, blue dye was injected sub-dermally after anaesthetic induction. Results: From October 2004 to December 2008, 210 SLNB naive surgeons, in 103 centres, performed 6,685 SLNB procedures of which 31% (2,098/6,685) were node positive. The mentorship training model was followed in 87% (5,849/6,685). Scintigraphy identified axillary lymph node drainage in 85% (5,564/6,511) with an overall SLN localization rate of 98.9% (6,610/6,685, 95% CI 98.6% to 99.1%). Node positivity was higher (P<0.001) for failed (58.7%, 44/75) than successful (31.1%, 2054/6610) localizations. The mentorship false negative rate (FNR) was 8.9% (163/1821, 95% CI 7.7% to 10.4%). The median SLN yield was 2.0 (range 1-11). SLN localization and FNR improved with surgeon caseload so that after 20 procedures the FNR fell below 10% but no statistically significant learning curve was identified. The FNR patients who had one SLN harvested was 14.8%. The FNR rate declined to 9.4%, 6.3%, 4.5% and 4.0% for those patients with 2, 3, 4 and more than 4 SLNs removed. Conclusion: NEW START demonstrates that a standardized injection protocol and structured multi-professional training can abolish learning curves so ensuring patient safety during national adoption of a new technique. Tumor quadrant injection using both isotope and dye has a high localization rate and low false-negative rate. Failed localization indicates higher probability of axillary nodal involvement. It is not necessary to remove more than 4 SLNs to achieve a FNR of less than 5%. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P1-01-01.