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.
Pre-implementation: standard sentinel node procedure using 99mTc-nanocolloid, which implies 99mTc injection the day or the morning before surgery. Transition period: participating surgeons will receive on-site training, proctoring, and ongoing guidance from experienced surgeons and early adopters of the ICG method from St. Antonius Hospital, Utrecht, The Netherlands until they achieve confidence and proficiency in using ICG for SLNB. Post-implementation: 5 mg (2 ml) ICG will be injected periareolar after administration of general anesthesia and before incision. The SLN will be visualized by fluorescent imaging using a fluorescence camera. Main study endpoints: Primary endpoint is the identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG. Secondary endpoints are total number of LNs removed, detection time, total operative time, complications and (serious) adverse events, loco regional recurrence after 1 year follow-up, pre-implementation expectations regarding ICG, post-implementation experiences regarding ICG including barriers and success factors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
ICG used as a tracer for sentinel lymph node instead of technetium 99
technetium 99 used as a tracer for sentinel lymph node instead of ICG
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, Italy
RECRUITINGIdentification 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 (%)
Time frame: through study completion, an average of 1 year
Percentage of SLNs that has 99mTc uptake/ is fluorescent
Percentage of sentinel lymph nodes that have an absorption of 99mTc and are fluorescent (%)
Time frame: through study completion, an average of 1 year
Detection time
Detection time is defined as time between skin incision and SLN resection in minutes (min)
Time frame: through study completion, an average of 1 year
Total operative time
Registration of the duration of the total surgical procedure including the SN-procedure (min or h)
Time frame: through study completion, an average of 1 year
Number of complications and (serious) adverse events
registration of the number of serious adverse events and complications, including seroma, wound infection and bleeding
Time frame: through study completion, an average of 1 year
loco regional recurrence after 1 year follow-up
number of regional loco recurrences assessed through clinical examinations
Time frame: through study completion, an average of 1 year
The pathology of SLNs identified
number of micro and macro metastases and isolated tumor cells (ITCs)
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Time frame: through study completion, an average of 1 year