Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Calcemia
研究概览
简要总结
The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia.
详细描述
The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:
- To study the correlation between parathyroid vascularization (intraoperative fluorescence intensity) and postoperative glandular function (serum calcium and parathormone levels).
- To compare the surgeon's subjective assessment of parathyroid fluorescence in the groups of patients with and without postoperative hypocalcemia.
- To compare the objective assessment of parathyroid fluorescence, by using specific computer software developed ad hoc, in the groups of patients with and without postoperative hypocalcemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection.
- •Visualization of 2 or more parathyroid glands during the surgical act.
- •Normal renal and hepatic functions.
- •Absence of a history of hypersensitivity reactions to iodine or indocyanine green.
- •Able to understand the nature and protocol of the study and its procedures
- •Willingness to participate with the subsequent signing of informed consent.
排除标准
- •Age <18 years
- •Hepatic or renal insufficiency
- •Hypersensitivity to iodine or to indocyanine green.
- •Pregnancy or lactation
- •Inability to understand the nature and procedures of the study.
- •Patients with known preoperative hyperparathyroidism.
研究组 & 干预措施
ICG
Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Calcemia
时间窗: Day 1 after surgery
Serum calcium level at 24 hours postoperatively
Objective parathyroid fluorescence
时间窗: Intraoperatively
Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.
Subjective parathyroid fluorescence
时间窗: Intraoperatively
Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured on a subjective analogue scale (0: no fluorescence, 1: hypofluorescence or heterogeneous fluorescence, 2: homogeneous hyperfluorescence).
次要结局
- Vitamin D(Preoperative blood test)
- PTH preop(Immediately before surgery)
- Time(Inmediately after surgery)
- Sex(Baseline)
- Age(Baseline)
- Body mass index(Baseline)
- Surgery date(Baseline)
- Preoperative diagnosis(Baseline)
- PTH 10 min(10 minutes post-thyroidectomy)
- Surgery(Inmediately after surgery)
- Parathyroid glands(During surgery)
- Thyroid weight(during the first month after surgery)
- Drain(Inmediately after surgery)
- Stay(During the first month after surgery)
- Complications(During the first month after surgery)
- PTH day 1(Day 1 after surgery)
- Parathyroid gland location(During surgery)
- Pathologic result(during the first month after surgery)
- PG in piece(during the first month after surgery)