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临床试验/NCT04204317
NCT04204317已完成不适用

Does Parathyroid Autofluorescence Reduces Unintensional Parathyroidectomy During Total Thyroidectomy?

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy.

研究概览

简要总结

The aim of the study is to evaluate the effectiveness of autofluorescence in the intraoperative preservation of parathyroids during total thyroidectomy

详细描述

Real-time intraoperative identification and functional maintenance of structures are of major importance in endocrine surgery, with a critical role in clinical outcomes and patients' quality of life. Despite the advances in preoperative imaging techniques, there is still need for precise intraoperative visualizing. Limitations of naked eye inspection and subjectivity of palpation are imposing challenges even for the most experienced surgeons. Nowadays, attention is attracted to intraoperative imaging techniques using Near Infrared Fluorescence (NIRF) with endogenous or exogenous contrast agents. These imaging techniques are attractive in biomedicine due to its high penetration depth and low scattering in human tissue.

Autofluorescence is the ability of several natural substances or drugs to be fluorescent after the absorbance of light or radiation. It has been already proved that parathyroid glands emit their own light after near-infrared (NIR) around 820nm , providing high contrast to the surrounding tissues. This made near-infrared autofluorescence a potential useful tool in hands of experienced endocrine surgeons in order to distinguish parathyroid glands from other anatomic structures during thyroidectomies.

Approximately 7.6% of thyroid surgeries resulted in hypoparathyroidism, with 75% of these cases being transient and 25% being chronic. The mechanisms that underlie hypoPTH are related to disruption of parathyroid arterial supply or venous drainage, mechanical injury, thermal or electrical injury, and either intentional or inadvertent partial or complete removal.

The aim of the present study is to evaluate the value of intra-operative autofluorescence imaging concerning the unintentional excision rate of parathyroids during total thyroidectomy. Moreover, the investigators are going to evaluate correlation of autofluorescence with 24 hours post-operative PTH.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patient is over 18 years old
  • Patient scheduled for a non-emergency operation
  • Patient eligible for total thyroidectomy

排除标准

  • Patient is participating in another clinical trial which may affect this study's outcomes
  • Prior operation in the neck
  • Primary or secondary hyperparathyroidism
  • Vitamin D deficiency
  • Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)

结局指标

主要结局

The contribution of intra-operative autofluorescence imaging on unintentional excision rate of parathyroids during total thyroidectomy.

时间窗: 6 months

The aim of the study is to evaluate the use of autofluorescence to distinguish parathyroid glands during thyroidectomy

次要结局

  • Identifying and analyzing problematic groups of patients(6 months)
  • Detecting the changes of practice in performing total thyroidectomy when monitoring parathyroids with autofluorescence.(6 months)
  • Comparing autofluorescence monitored minimal invasive total thyroidectomy with classic minimal invasive total thyroidectomy(6 months)
  • Correlating autofluorescence with 24 hours post-operative PTH.(7 months)
  • Identifying the cut-off points that predict low PTH levels (less than 20pg/ml)(7 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Papavramidis Theodossis

Assistant Professor of Surgery

Aristotle University Of Thessaloniki

研究点 (1)

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