The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of participants with successful ablation
研究概览
简要总结
The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.
详细描述
The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. Primary outcome is the surgical completeness, recurrence rate, and successful ablation rate. Secondary outcomes are the incidence of postoperative complications and PTC stage. The enrolled patients were randomly assigned to control group and intervention group (1:1 allocation).
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •were as follows:
- •patients aged 20 to 70 years old
- •patients diagnosed with PTC or suspicious for PTC on fine needle aspiration or core needle biopsy
- •patients with no evidence of LNM before and during surgery(cN0)
- •patients with no evidence of distant metastasis(cM0).
排除标准
- •were as follows:
- •patients suspected of advanced PTC(clinically T3 or T4) such as invasion of peripheral organs on preoperative examination
- •patients who have previous history of cervical radiation therapy or surgery.
- •pregnant women
- •uncontrolled diabetes, hypertension, or chronic renal failure
- •aspirin or anticoagulant medication within 7 days
- •other clinical trial participation within 30 days
- •radiation exposure to the head and neck
- •previous operation to the neck
- •advanced thyroid cancer including adjacent organ invasion
研究组 & 干预措施
No prophylactic central dissection
Patients underwent total thyroidectomy for papillary thyroid carcinoma, without prophylactic central lymph node dissection
Prophylactic central dissection
Patients underwent total thyroidectomy for papillary thyroid carcinoma, with prophylactic central lymph node dissection
干预措施: prophylactic central lymph node dissection (Procedure)
结局指标
主要结局
Number of participants with successful ablation
时间窗: Participants will be followed from the operation to 5 year (maximum)
Successful ablation was defined as a patient whose stimulated Tg level was measured as \<1 ng/mL at last ablation.
Recurrence rate of thyroid cancer
时间窗: Participants will be followed from the operation to 5 year (maximum)
Recurrence was defined according to the definition of response to therapy in the 2015 American Thyroid Association(ATA) guidelines.
The number of participants with successful surgical completeness
时间窗: Participants will be followed from the operation to 5 year (maximum)
In the case of patients undergoing RAI ablation, surgical completeness was defined as cases with a negative ultrasonographic finding with postoperative 1st stimulated Tg \<1 ng/mL. In patients who did not undergo RAI treatment, the case with a negative finding at the 1st postoperative ultrasound with postoperative 1st unstimulated Tg \<0.2ng/mL was defined as surgical completeness.
次要结局
- postoperative complication occurrence rate(Participants will be followed from the operation to 5 year (maximum))
- impact of prophylactic central lymph node dissection on staging of papillary thyroid cancer(PTC)(TNM stage of each case was confirmed after final pathologic reports. At our facility, final pathologic reports would be turned out at an average of 2 weeks after surgery)
研究者
Kyu Eun Lee
Assistant Professor
Seoul National University Hospital