Near-infrared (NIR) Fluorescence Imaging With Indocyanine Green (ICG) for Identification of Sentinel Lymph Nodes and Parathyroid Glands During Total Thyroidectomy: Prospective Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure
- •Patients at or over 17 years
Exclusion Criteria
- •Previous thyroid surgery
- •Patients below 17 years
Arms & Interventions
Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy
Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC)
Standard TT+CLND procedure only
Intervention: Total thyroidectomy (TT) (Procedure)
Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy
Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC)
Standard TT+CLND procedure only
Intervention: Central lymph node dissection (CLND) (Procedure)
Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
Experimental group- Sentinel lymph node dissection (SLND) after intratumoral indocyanine green (ICG) injection and visualization of all 4 parathyroid glands with infra-red (NIR) fluorescence after intravenous (iv) ICG injection, during total thyroidectomy and central lymph node dissection (CLND).
TT+CLND with NIR fluorescence ICG
Intervention: Total thyroidectomy (TT) (Procedure)
Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
Experimental group- Sentinel lymph node dissection (SLND) after intratumoral indocyanine green (ICG) injection and visualization of all 4 parathyroid glands with infra-red (NIR) fluorescence after intravenous (iv) ICG injection, during total thyroidectomy and central lymph node dissection (CLND).
TT+CLND with NIR fluorescence ICG
Intervention: Central lymph node dissection (CLND) (Procedure)
Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
Experimental group- Sentinel lymph node dissection (SLND) after intratumoral indocyanine green (ICG) injection and visualization of all 4 parathyroid glands with infra-red (NIR) fluorescence after intravenous (iv) ICG injection, during total thyroidectomy and central lymph node dissection (CLND).
TT+CLND with NIR fluorescence ICG
Intervention: Sentinel lymph node (SLN) bopsy (Diagnostic Test)
Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
Experimental group- Sentinel lymph node dissection (SLND) after intratumoral indocyanine green (ICG) injection and visualization of all 4 parathyroid glands with infra-red (NIR) fluorescence after intravenous (iv) ICG injection, during total thyroidectomy and central lymph node dissection (CLND).
TT+CLND with NIR fluorescence ICG
Intervention: Identification of parathyroid glands (PGs) (Diagnostic Test)
Outcomes
Primary Outcomes
Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion
Time Frame: 1 year
Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy
Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast
Time Frame: 1 year
İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)
Secondary Outcomes
- Central lymph node dissetion (CLND)(1 year)
Investigators
Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
A. Prof. of General Surgery and Surgical Oncology
Umraniye Education and Research Hospital