Abstract
Background Sentinel lymph node biopsy (SLNB) by means of radio-guided surgery (RGS) is the standard for pathologic staging of axillary lymph nodes in breast patients. Herein, a prospective clinical study was performed to assess the efficacy and effectiveness of indocyanine green (ICG) compared to RGS. Patients and Methods: Between 2016 and 2017, 54 patients with early.stage breast cancer <2 cm and clinically negative lymph node underwent combined SLNB by means of ICG with HyperEye Medical System (HEMS) and standard RGS at the Breast Unit of “Ospedale Policlinico San Martino” in Genoa-Italy. Results: At least one sentinel lymph node was identified by ICG in 52 out of 54 patients with 96.3% detection rate of ICG as compared to 100% with RGS. ICG detection was cheaper if the cost of the device was not included; when also this cost was added, the breakeven point could have been reached when at least 118 patients undergo ICG detection of SLNB, with an expected saving of about 254.00 € per patient. Conclusions: The efficacy of ICG was quite acceptable and, as regards its effectiveness, the amortization of the higher costs of HEMS will be faster in high-volume as compared to low-volume centers (3 months vs. 17 months) due to the initial cost of the instrumentation.
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