Indocyanine green fluorescence-guided lumpectomy of nonpalpable breast cancer versus wire-guided excision: A randomized clinical trial.

Abstract

The use of wire localization (WL) for excisions of nonpalpable breast cancer (NBC) has several disadvantages. The purpose of this study was to evaluate the use of indocyanine green-guided nonpalpable breast cancer lesion localization (INBCL) and to compare it with WL. A total of 62 patients with a preoperative histological diagnosis of NBC lesions that could be visualized with ultrasound and mammography were randomized to INBCL or WL. Patients with preoperatively diagnosed primary ductal carcinoma in situ and multifocal disease were excluded from the study. Significance was considered at P < 0.05. Of all 62 excision, 32 (51.6%) were guided by INBCL and 30 (48.4%) by WL. Both techniques resulted in 100% retrieval of the lesions. The rate of clear margins was significantly higher in the INBCL group (87.5%; 28/32) compared to the WL (63.3%, 19/30) (P=0.026), reducing the requirement of re-excision. When results of the excised tissue are taken into account, the mean volume of the INBCL specimen was 56cm3 less than that of the WL group, although this was not significantly different (P=0.058). INBCL for NBCs was more accurate than WL, because it optimized the surgeon's ability to obtain clear margins. A smaller volume of the tissue may be excised by using INBCL technique. Therefore INBCL is an attractive alternative to WL.