Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism - a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Hypoparathyroidism
研究概览
简要总结
The study aims to test if use of autofluorescence imaging (AF) reduces the risk of developing hypoparathyroidism (hypoPT) following surgery for thyroid cancer, either total thyroidectomy (TT) or completion hemithyroidectomy (cHT).
详细描述
Purpose The study aims to test if use of autofluorescence imaging (AF) reduces the risk of developing hypoparathyroidism (hypoPT) following surgery for thyroid cancer, either total thyroidectomy (TT) or completion hemithyroidectomy (cHT).
Background The mainstay of treatment of thyroid cancer is surgery. Many patients will need only surgery with removal of one half of their thyroid gland, a hemithyroidectomy (HT), while others will need to have all of the thyroid gland removed.1 This may be done in one procedure, a total thyroidectomy (TT), or in two procedures with a completion hemithyroidectomy (cHT) after an initial HT. The indication for complete removal of the thyroid gland, may be to remove all cancer tissue, to facilitate adjuvant treatment with radioactive iodine, or both.
Following adequate treatment, overall prognosis is very favorable, with a 3-year overall survival of 98% for all Danish patients diagnosed in 2018.2 Thus, a major point of attention is to minimize treatment-related morbidity, and enable cancer survivorship with as few late-effects as possible.
Surgery for thyroid cancer comes with general surgical risks of bleeding and infection, and specific for thyroid surgery is the risk of injury to nerves to the larynx, which is relatively rare, below 5%. Hypothyroidism is obligatory after TT/cHT, and is seen in 10-15% after HT.
Specific to patients after TT/cHT is damage to the parathyroid glands (PGs), which leads to hypoparathyroidism (hypoPT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age>18 years and able to give informed consent.
- •Suspicion or diagnosis of thyroid cancer.
- •Planned total thyroidectomy or completion thyroidectomy.
- •Normocalcemia prior to surgery.
排除标准
- •Planned simultaneous parathyroid surgery.
- •Treatment with active vitamin D analogues.
- •eGFR < 30.
结局指标
主要结局
Hypoparathyroidism
时间窗: 6 and 12 months
Proportion of patients who develop transient or permanent hypoPT requiring medical treatment with active vitamin D. HypoPT is diagnosed and treated according to protocol.
次要结局
- Time to resolution of transient hypoPT.(12 months)
- Intra-operative reduction in plasma concentration of PTH.(During surgery)
- Permanent hypoparathyroidism(6 and 12 months)
- Oncological and composite outcomes(2 years)
- Number of days hospitalized(30 days)
研究者
Jacob Kinggaard Lilja-Fischer
MD
Aarhus University Hospital