Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,000
- 主要终点
- Recurrence of thyroid cancer
研究概览
简要总结
This study is divided into three stages. In the first stage, the investigators try to explore the objective clinical imaging standard of cN0PTC on the basis of previous studies, formulate the "clinical imaging standard of cN0PTC", and randomly enroll 2000 patients under the premise of meeting the standard to establish the "predictive model of cN0-pN+PTC".
In the second stage, 2000 patients will be enrolled to test and improve the evaluation efficiency of "cN0-pN+PTC prediction model".
In the third stage, 2 000 patients without lymph node metastasis assessed by "cNo-pN+ PTC prediction model" will be randomly divided into experimental group and control group. The experimental group will be treated with pCND, while the experimental group will be treated without pCND. The central lymph node metastasis probability, the number and size of metastatic lymph nodes in the control group will be observed after operation. The two groups will be followed up for 5, 10, 15 and 20 years to observe the RFS and OS, so as to further evaluate the "cN0-pN+PTC prediction model" scientifically.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase I and II:
- •aged 18 to 80 years old;
- •the primary treatment of patients with unilateral or bilateral PTC;
- •ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
- •ultrasonography of cervical VI lymph nodes: the shortest diameter < 4 mm, no calcification, no cystic change, no local or global echo enhancement;
- •CT scan of cervical VI lymph nodes: the shortest diameter < 4 mm, no calcification, no cystic change, no enhancement (CT value 40HU or not higher than banded muscle level), no cluster distribution;
- •patients will voluntarily enter the study after informed consent;
- •aged from 18 to 80 years old;
- •ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
- •Unilateral or bilateral PTC without lymph node metastasis assessed by "cNo-pN+ PTC prediction model";
- •patients will voluntarily enter the study after informed consent.
排除标准
- •(1) patients refused to participate in the study; (2) non first operation patients; (3) Lateral cervical lymph nodes or distant metastasis; (4) Hashimoto's disease; (5) history of neck trauma.
研究组 & 干预措施
non central cervical dissection
干预措施: lymph node dissection (Procedure)
central cervical dissection
干预措施: lymph node dissection (Procedure)
结局指标
主要结局
Recurrence of thyroid cancer
时间窗: Participants will be followed from the operation to 20 year (maximum)
次要结局
未报告次要终点
研究者
Luo Dingcun
vice president of hospital
Zhejiang University