Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope. In this study, our hypotheses are as following: 1. Multimodal method enables to increase identification rate of SLNB 2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome 3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy
Indocyanine green Advantages: provides visualization of sentinel lymph node without incision Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
86
Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation
Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Time to sentinel lymph node biopsy
From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up).
Time frame: up to 6 months
Identification rate of sentinel lymph node biopsy
The number of participants with sentinel lymph node detection is assessed up to 13 months.
Time frame: 13 months
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