This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
Clinically node-negative, DCIS or invasive stage T1-T3 breast cancer confirmed by biopsy
Preoperative axillary ultrasound to confirm clinical node-negative status
Indication for breast cancer surgery with SLNB via axillar incision
Written informed consent according to national regulations
Patients < 18 years old.
Indication for breast cancer surgery with SLNB via mastectomy incision
Known allergy for ICG, intravenous contrast or iodine
History of axillary lymph node dissection
Parallel
ICG used as a tracer for sentinel lymph node
Procedure/SurgeryICG used as a tracer for sentinel lymph node instead of technetium 99
technetium 99 used as a tracer for sentinel lymph node
Procedure/Surgerytechnetium 99 used as a tracer for sentinel lymph node instead of ICG
Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG
measure the percentage of sentinel lymph nodes identified by the 99mTc nanocolloid or the ICG fluorescent signal (%)
Percentage of SLNs that has 99mTc uptake/ is fluorescent
Percentage of sentinel lymph nodes that have an absorption of 99mTc and are fluorescent (%)
Detection time
Detection time is defined as time between skin incision and SLN resection in minutes (min)
Total operative time
Registration of the duration of the total surgical procedure including the SN-procedure (min or h)
Number of complications and (serious) adverse events
registration of the number of serious adverse events and complications, including seroma, wound infection and bleeding
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