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The Learning Curve in Sentinel Node Biopsy: The ALMANAC Experience

From the University Department of Surgery (DC, REM) and Department of Epidemiology, Statistics and Public Health (RGN), University of Wales College of Medicine, Heath Park, Cardiff, United Kingdom, on behalf of the ALMANAC Trialists Group.

Correspondence: Address correspondence and reprint requests to: Robert E. Mansel, MS, FRCS, Principal Investigator, ALMANAC Trial, University Department of Surgery, University of Wales College of Medicine, Heath Park, Cardiff CF14 4XN, United Kingdom; Fax: 029-2076-1623; E-mail: manselre{at}cf.ac.uk

ABSTRACT

Sentinel node biopsy (SNB) is a minimally invasive procedure to stage the axilla in patients with breast cancer. Like any new surgical procedure, it is associated with a learning curve. This article describes the learning curve as part of the ALMANAC trial. The first phase of this trial is a validation phase in which surgeons perform SNB followed by an immediate axillary dissection in a consecutive series of 40 patients with invasive breast cancer. Each surgeon completes a mandatory program of proctored training during this phase. Surgeons who achieve a localization rate of 90% or more and a false-negative rate of 5% or less are eligible to proceed to the randomized phase. All 13 surgeons who completed 40 procedures as part of the validation phase of the ALMANAC trial achieved the set target. This study shows that a standardized training program allows surgeons to achieve a satisfactory localization rate and an acceptable false-negative rate after 40 SNBs.

Key Words: Breast cancer • False-negative rate • Learning curve • Localization rate • Sentinel node biopsy

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