Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) imaging has been recently introduced, and has been suggested as a useful tool for the identification and preservation of the parathyroid glands (PGs) during total thyroidectomy (TT). ICG can also be used for sentinel lymph node (SLN) biopsy to predict the micrometastases in central lymph nodes (CLN) in thyroid carcinoma, and central lymph node dissection can reduce local recurrence.
Incidence of thyroid cancer has doubled between 1980 and 2020, and it is now the fifth most common malignant tumor among women. The majority are papillary thyroid cancer (PTC), and TT is the procedure of choice. Since the micrometastasis rate of the central lymph nodes (CLNs) is about 30% to 90% in PTC, CLN dissection can improve the prognosis and reduce tumor recurrence as well as provide accurate information for the evaluation of tumor staging. However, TT procedure has some important complications such as vocal cord paralysis (VCP) and hypocalcemia (due to accicental parathyroidectomy or damage to the parathyroid gland-PG- vasculature). Use of intraoperative nerve monitoring (IONM) has reduced the rate of VCP. However, the incidence of postoperative hypocalcemia is still high (15-70%), and it is now the most common complication of TT. Intraoperative identification of SLNs and PGs can help surgeon to overcome these problems.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Standard TT procedure for thyroid carcinoma, for both groups
Standard CLND for thyroid carcinoma, for both groups
Intrathyroidal injection of ICG for SL biopsy, for only experimental group
Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
Umraniye Education and Research Hospital, Department of General Surgery
Istanbul, Turkey (Türkiye)
RECRUITINGInvolvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion
Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy
Time frame: 1 year
Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast
İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)
Time frame: 1 year
Central lymph node dissetion (CLND)
Number of positive lymph nodes (micrometastases)
Time frame: 1 year
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