Multi-center, 1:1 Randomized, Stratified, Parallel-group, Non-inferiority Clinical Trial of Small Thyroid Cancers Treated With Hemithyroidectomy or Radiofrequency Ablation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Uncomplicated initial treatment (yes/no)
研究概览
简要总结
This is a multicenter randomized controlled trial including patients with small (<2 cm) suspected or confirmed thyroid cancers. Patients are included after informed consent and randomized to one of two treatments. One treatment is a standard henithyroidectomy and the second treatment is radiofrequency ablation (RFA) of the specific tumor. The investigators will evaluate initial outcome of the allocated treatment, thyroid hormonal function, oncologic safety, quality of life, and treatment costs in a follow-up period of five years after treatment.
The overall aim of the study is to improve patient's health by reducing the number of operations on small thyroid cancers. In patients with these small tumors, the long-term adverse outcome may be higher than possible benefits from the operation. For participants undergoing surgical treatment with HT, the investigators will measure final histology and both beneficial and adverse outcome from the operation. For participants undergoing RFA, the investigators expect to reduce the need for thyroid hormonal substitutions, reduce the surgical adverse outcomes, reduce treatment costs and increase QoL without a reduction in oncologic safety and outcome.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single tumor in the thyroid gland with a FNAB suspecious of cancer or diagnostic of cancer (category V or VI in the Bethesda system)
- •tumor size of less than 2 cm in all dimensions.
排除标准
- •suspicion of disseminated disease because of PET-positive lymph nodes ; suspect lymph-nodes by ultrasonography (US); or signs of capsular invasion of the tumor OR
- •tumor not eligible for RFA treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol//L ) OR
- •if the patient is pregnant OR
- •If the patient is unable to give informed consent.
研究组 & 干预措施
Surgery of thyroid cancer
干预措施: Surgery (Procedure)
RFA of thyroid cancer
干预措施: Radiofrequency ablation alone (Procedure)
结局指标
主要结局
Uncomplicated initial treatment (yes/no)
时间窗: One month after randomization.
Uncomplicated treatment is defined as a composite endpoint (dichotomous; yes/no) with none of the following adverse outcomes within the first month after treatment/surgery: 1. short or long-term affection of the recurrent laryngeal nerve (RLN) based on laryngoscopy, 2. infection with a need for surgical treatment, 3. capsule rupture or bleeding with a need for operation, 4. prolonged hospital stay (more than one night), 5. any other reason for a secondary surgical intervention on the neck.
次要结局
- Oncologic(5 years after randomization.)
- Endocrinological 1(At three months, 1, 2, 3, 4 and 5 years after randomization.)
- Patient-reported outcome 1(At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.)
- Health economics(At 5 years after randomization.)
- Patient-reported outcome 2(At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.)