Comparing the Therapeutic Efficacy of Extended Isthmusectomy Versus Total Thyroidectomy for Isthmus Tumors of the Thyroid: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Rate of 3-year recurrence
研究概览
简要总结
Prospective randomized open phase III non-inferiority trial in cT1bN0N1aM0 isthmus tumors of the thyroid comparing: extended Isthmusectomy (Isthmusectomy + Central Neck Dissection)(experimental group) versus total thyroidectomy + Central Neck Dissection (reference group).
详细描述
The thyroid isthmus is a narrow structure connecting the two lobes of the thyroid. Papillary carcinoma arising from this site accounts for only 1-9% of all thyroid cancers. However, due to its unique anatomical location, it is more prone to extranodal extension and bilateral lymph node metastasis, exhibiting more aggressive biological behavior. The optimal extent of surgery remains controversial: total thyroidectomy facilitates postoperative radioactive iodine therapy and monitoring but results in permanent dependence on thyroid hormone replacement and increases the risk of complications such as hypocalcemia, adversely affecting patients' quality of life. In contrast, conservative approaches like extended isthmusectomy can preserve partial thyroid function, reduce complications, and maintain a better quality of life, making them particularly suitable for low-risk patients with small tumors and no metastasis. Existing retrospective studies indicate no significant difference in recurrence rates between the two surgical approaches, though the evidence remains limited. Therefore, this study aims to conduct a prospective, multicenter, open-label, parallel-controlled, randomized trial to directly compare total thyroidectomy and extended isthmusectomy in terms of postoperative recurrence rates, quality of life, and complications, thereby providing high-quality evidence for surgical decision-making.
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 or older.
- •Diagnosis of low-risk differentiated thyroid cancer (papillary, follicular, or Hürthle cell carcinoma).
- •Unifocal tumor located in the thyroid isthmus, cT1b
- •No evidence of extrathyroidal extension, assessed by preoperative ultrasound.
排除标准
- •- Aggressive pathological subtypes (e.g., tall cell, clear cell, columnar cell, or diffuse sclerosing variants of papillary thyroid carcinoma, as well as poorly differentiated types).
- •Combined with other suspicious thyroid nodules within the lobes.
结局指标
主要结局
Rate of 3-year recurrence
时间窗: maximum of 3 years after the surgery
defined as thyroid cancer recurrence, metastatic disease from thyroid cancer (whichever occurs first)
次要结局
- Health Related Quality of Life(Baseline (post-randomisation/pre-surgery), 4 weeks and 3, 6,12 months after the surgery)
- Rate of surgical complications(perioperatively, 2-4 weeks, 6 months after the surgery)
- Anatomical location of tumor recurrence(maximum of 3 years after the surgery)
- Risk of surgical site recurrence(maximum of 3 years after the surgery)
- Health Related Quality of Life(Baseline (post-randomisation/pre-surgery), 4 weeks and 3, 6,12 months after the surgery)
- Number of participants with Hormone Replacement Therapy(2-4 weeks and 3, 6, 12, 24, 36 months after the surgery)
- Rate of surgical complications(perioperatively, 2-4 weeks, 6 months after the surgery)
