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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure
- •Patients at or over 17 years
排除标准
- •Previous thyroid surgery
- •Patients below 17 years
研究组 & 干预措施
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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: Identification of parathyroid glands (PGs) (Diagnostic Test)
结局指标
主要结局
Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion
时间窗: 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
时间窗: 1 year
İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)
次要结局
- Central lymph node dissetion (CLND)(1 year)
研究者
Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
A. Prof. of General Surgery and Surgical Oncology
Umraniye Education and Research Hospital