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临床试验/NCT06288750
NCT06288750Unknown不适用

Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy

Shandong Linglong Yingcheng Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast

研究概览

简要总结

Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Near-infrared fluorescence imaging (NIFI), including the autofluorescence (AF) and indocyanine green fluorescence (ICGF) imaging, is a promising technique to protect PGs. This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy.

详细描述

Postoperative hypoparathyroidism or hypocalcemia is the most frequent complication after total thyroidectomy (TT) . The median incidence of transient and permanent postoperative hypoparathyroidism is 27% (19%-38%) and 1% (0-3%), respectively. Transient hypoparathyroidism can increase the length of hospital stay and the costs of hospitalization for patients. Permanent hypoparathyroidism leads to lifelong medication use, which may severely impair the quality of life of patients. Therefore, identifying the parathyroid glands (PGs) and preserving those with adequate blood perfusion intraoperatively has always been a crucial procedure during thyroidectomy.

Conventional means of identification and assessment of PGs are mainly based on surgeon-dependent identification of their anatomical location and appearance (color, shape, etc.) by the naked eye. However, this visual inspection is often influenced by the experience of the surgeon, intraoperative hemorrhage, ectopic PGs and so on, which makes it difficult to fully protect the PGs.

Currently, there has been an emergence of near-infrared fluorescence imaging (NIFI) that can be applied during thyroid or parathyroid surgery for the evaluation and identification of PGs. This technique mainly exploits the autofluorescence (AF) of PGs and indocyanine green fluorescence (ICGF ) imaging.PGs could exhibit stronger AF than the surrounding tissue under near-infrared light, which can be exploited to accurately identify PGs in real time. Subsequent studies have demonstrated that AF can not only detect PGs intraoperatively in real time and improve the intraoperative identification of PGs but also reduce the incidence of postoperative hypoparathyroidism. However, AF cannot assess the status of PG blood perfusion and consequently is not useful when determining whether PGs need to be autotransplanted.

Indocyanine green (ICG) fluorescence imaging may be a great solution to this problem. ICG is a safe fluorescent dye with fast metabolism and few adverse effects that can quickly combine with plasma proteins after intravenous injection and is widely used in angiography in multiple surgical disciplines. In recent years, several studies have shown that ICGF may be superior in evaluating blood perfusion and predicting the function of PGs in situ, subsequently guiding their autotransplantation. However, ICGF may not be very suitable for the identification of PGs before dissection, as the thyroid gland would also emit intense fluorescence after the injection of ICG, which may lead to difficulties in distinguishing them. Thus, AF and ICGF have their own advantages and disadvantages in the identification and evaluation of PGs, respectively. These two methods can be considered complementary.

In the present study, the investigators used AF in combination with ICGF imaging by one fluorescence imaging system during different steps of the surgical procedure. At the beginning of the operation, AF was used to identify the PGs before any dissection. Then, after the thyroid gland was removed, AF was used again to locate the PGs in situ. Finally, ICGF was applied to evaluate the blood perfusion of the PGs in situ and guide their autotransplantation. The aim of this randomized controlled trial was to assess whether this strategy could reduce the incidence of postoperative hypoparathyroidism and benefit the identification and evaluation of PGs during total thyroidectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients, aged 18 years and above
  • Scheduled for elective total or hemi thyroidectomy
  • Normal liver and renal function
  • No known hypersensitivity for iodine or ICG
  • Able to understand the nature of the study procedures
  • Willing to participate and give written informed consent

排除标准

  • Age < 18 years
  • Liver or renal insufficiency
  • Known ICG, iodine, penicillin or sulfa hypersensitivity
  • Pregnancy or breastfeeding
  • Not able to understand the nature of the study procedure
  • Not willing to participate

研究组 & 干预措施

Traditional surgery group

Active Comparator

Conventional means of identification and assessment of PGs are mainly based on surgeon-dependent identification of their anatomical location and appearance (color, shape, etc.) by the naked eye.

干预措施: No indocyanine green (Device)

结局指标

主要结局

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

发起方
Shandong Linglong Yingcheng Hospital
申办方类型
Network
责任方
Sponsor

研究点 (1)

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