Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quantification of the fluorescent signal of ICG
研究概览
简要总结
This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.
详细描述
Background Thyroid surgery volume continues to increase worldwide over the past few decades. During a total thyroidectomy (TTx), the ultimate goal is to remove all thyroid tissue, whereas damage to adjacent tissue is prevented. However, iatrogenic hypoparathyroidism, as a result of surgical removal or damage to the parathyroid glands, occurs in approximately 30% of the cases. In 2016 near-infrared fluorescence guided surgery with indocyanine green (ICG) was proposed for visualizing viability and blood supply of parathyroid glands during TTx. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins once in the bloodstream, and circulates in the intravascular compartment only. However, one of the limitations of ICG imaging is the subjectivity of the interpretation of fluorescence, which makes the assessment of images inconsistent among studies. There is a clear need for standardization of the evaluation of the perfusion with ICG, since visual evaluation of the fluorescent signal of ICG is not sufficient to reliably predict the perfusion of parathyroid glands.
Main research question To develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy including quantitative evaluations of the fluorescent signal.
Design This will be a proof-of-concept , prospective cohort study of patients undergoing a total thyroidectomy with ICG-guided fluorescent surgery to evaluate tissue perfusion The main study endpoint is quantification of the fluorescent signal of ICG. Secondary outcomes are data from surgery, postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 ≥ 18 years
- •Patients undergoing total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter
- •Patients are eligible for surgery
- •Patients are mentally competent and are able and willing to comply with study procedures
- •Written informed consent
排除标准
- •Patients with a known allergy to ICG or iodinated contrast
- •Pregnant or lactating women
- •Patients with previous neck surgery
研究组 & 干预措施
Indocyanine Green
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Quantification of the fluorescent signal of ICG
时间窗: At time of surgery
Quantification of the fluorescent signal of ICG
次要结局
- Postoperative calcium concentration(Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative))
- Duration of surgery(From start to end of surgery)
- Appearance of parathyroid gland(At time of surgery)
- Postoperative PTH concentration(Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative))
- Rate of prescribed postoperative calcium medication(Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative))
- Rate of prescribed postoperative vitamin D medication(Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative))