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临床试验/NCT06169735
NCT06169735终止4 期

Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 417 人开始时间: 2024年4月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
417
试验地点
2
主要终点
Percentage of Parathyroid Glands identified by ICG

研究概览

简要总结

The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery.

详细描述

The accurate identification of the parathyroid gland is a crucial aspect of thyroid and parathyroid surgery. Failing to recognize the parathyroid gland during thyroidectomy can result in the inadvertent removal of the gland, leading to postoperative hypocalcemia. On the other hand, during parathyroidectomy, there is a risk of mistaking other structures, such as lymph nodes, for parathyroid adenomas, which can leave the patient without a cure. Currently UAB employs intraoperative PTH or radioactive isotope techniques in conjunction with surgeon judgment. However, both methods have limitations, including being time-consuming, posing logistical challenges, and not providing feedback before gland removal.

Parathyroid fluorescence is a relatively new technology. It was initially discovered that the parathyroid gland emits fluorescence, which distinguishes it from the surrounding tissues. Additionally, indocyanine green dye is readily taken up by the parathyroid gland, making its detection easy to the naked eye. Research has demonstrated that parathyroid fluorescence, with or without indocyanine green, is not only safe but also helps reduce postoperative hypocalcemia and locate lesions in patients with imaging-negative parathyroid adenomas. However, the current use of parathyroid fluorescence is not standardized, and further studies are needed to explore its clinical utility in terms of cure rates and postoperative complications.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • age greater than 18 years old

排除标准

  • Patients with iodine or shellfish allergies would be excluded.
  • Patients with allergy to indocyanine green.
  • Pregnancy

研究组 & 干预措施

Parathyroid patients

Experimental

patients who require parathyroid identification and preservation during parathyroid surgery maneuver

干预措施: SPY Portable Handheld Imaging (Device)

Parathyroid patients

Experimental

patients who require parathyroid identification and preservation during parathyroid surgery maneuver

干预措施: Indocyanine green (Drug)

结局指标

主要结局

Percentage of Parathyroid Glands identified by ICG

时间窗: 20 minutes

Measuring the percentage of the number of glands per participant that emit fluorescence. ICG Administration: All enrolled patients with scheduled thyroidectomy or parathyroidectomy will receive a standard cervical incision that afford access to either side of neck. Following sufficient exposure of thyroid, 25 mg of indocyanine green (ICG), reconstituted in 10 ml of sterile water, will be administered intravenously. A dosage of 1 ml of this solution will be injected into a peripheral IV line, followed by a 5 ml flush of normal saline to ensure the propagation of the dye within the vascular compartment. Fluorescent Imaging: Approximately 30 seconds post-administration, the parathyroid glands are expected to exhibit fluorescence under near-infrared imaging. The emitted fluorescence is anticipated to persist for approximately 20 minutes, allowing ample time for intraoperative evaluation of parathyroid viability and perfusion.

次要结局

未报告次要终点

研究者

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

Herbert Chen

Professor

University of Alabama at Birmingham

研究点 (2)

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