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临床试验/NCT05117853
NCT05117853招募中3 期

The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial

Onze Lieve Vrouw Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Postoperative hypocalcemia

研究概览

简要总结

  • Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy.
  • The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia.
  • Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery.
  • Injecting indocyanine green and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands.
  • This randomized clinical trial aims to investigate whether using autofluorescence and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia.

详细描述

Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. When defined as corrected serum calcium levels below 2.10 mmol/L, the temporary rates of hypocalcemia after a total thyroidectomy excluding lymph node neck dissection still easily exceed 20% (BAETS fifth national audit report, 2017). When extending the follow-up period to more than six months after surgery, late or permanent hypocalcemia is seen in over 5% of patients after a total thyroidectomy. These British numbers have been confirmed in large European and American databases. A large, Belgian, single-center analysis, including redo-surgery and lymph node neck dissections, confirmed temporary and permanent rates of hypocalcemia of 32% and 3%, respectively.

While temporary hypocalcemia results in a reduced quality of life, additional medical costs to the patients and the society, and hypocalcemia-related symptoms, permanent hypocalcemia adds an increased risk of developing renal failure, basal ganglia calcifications, neuropsychiatric derangements, and infections.

The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. The visual evaluation of parathyroid gland vascularization is even more challenging, prone to subjectivity, and depending on surgical experience and surgical volume. Moreover, even experienced endocrine surgeons appear to be unreliable in using visual scores to assess the viability of parathyroid glands.

Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery. However, this signal does not provide any information on viability and vascularization of the parathyroid glands. Injecting indocyanine green (ICG) and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands. The combined technique of autofluorescent and ICG-enhanced imaging suffers from lack of standardization, optimal technique, dosage, and timing of the ICG administration, and still must prove its possible benefit in a clinical setting.

Hence, this randomized clinical trial aims to investigate whether using autofluorescence (AF) and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia. By using parathyroid gland detection via autofluorescence imaging and verifying their viability after ICG injection, the authors aim to identify patients at risk of hypocalcemia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Simple blind (Only participant)

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

  • All adult patients undergoing a total thyroidectomy without previous neck surgery.

排除标准

  • Children and teenagers (<18 years old)
  • Patients refusing participation or unable/unwilling to sign the informed consent
  • Patients with a completion thyroidectomy
  • Patients with planned central and lateral neck lymph node dissections (thyroid cancer)
  • Patients with previous neck surgery
  • Patients with a known allergy/hypersensitivity to indocyanine green

研究组 & 干预措施

Autofluorescent detection and injection of indocyanine green

Experimental

Drug: indocyanine green (ICG)

Autofluorescence detection of the parathyroid glands and injection of indocyanine green at two predefined timepoints will be performed to evaluate the vascularization of the parathyroid glands.

干预措施: Autofluorescent detection + Injection of indocyanine green (Drug)

Control group

Placebo Comparator

Gold standard of visual identification and evaluation of viability.

干预措施: Gold standard of visual identification and evaluation of viability of the parathyroid glands. (Procedure)

结局指标

主要结局

Postoperative hypocalcemia

时间窗: One week after surgery

Defined as parathyroid hormone (PTH) levels \<15 pg/mL, serum calcium levels \<2.10 mmol/L, or the intake of calcium or activated vitamin D supplements after total thyroidectomy.

次要结局

  • The number of identified parathyroid glands(1 hour after surgery)
  • The number of reimplanted parathyroid glands(1 hour after surgery)
  • The presence of late or permanent hypocalcemia(Six months after surgery)

研究者

发起方
Onze Lieve Vrouw Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klaas Van Den Heede

Principal Investigator / Scientific Fellow

Onze Lieve Vrouw Hospital

研究点 (1)

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