Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)
研究概览
简要总结
The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.
详细描述
The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma.
Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings.
Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection.
Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study.
Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND)
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 70
- •Sonographically node-negative cytology confirmed thyroid papillary carcinoma
- •Tumor size less than 1 cm in sonography
- •Tumor confined to the one lobe of the thyroid gland
- •One who provides the informed consent
排除标准
- •History of radiation treatment to head and neck area
- •History of other malignancy except thyroid cancer
- •Poor performance status (ECOG 3-4)
结局指标
主要结局
Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)
时间窗: 3 year after initial treatment
次要结局
- Postoperative complications(hypocalcemia, hoarseness)(up to 3 years after surgery)