A Multicenter, Randomized, Controlled Clinical Study on the Feasibility and Safety of Gasless Transaxillary Posterior Endoscopic and Open Thyroidectomy for Papillary Thyroid Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Life quality score (1 month after surgery)
研究概览
简要总结
To evaluate the feasibility and safety of gasless transaxillary posterior endoscopic thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) and open radical thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) as the current standard surgical treatment mode in terms of feasibility and safety of radical thyroidectomy.
详细描述
Subjects that suffering from papillary thyroid carcinoma will be randomized into Study Group (gasless transaxillary posterior endoscopic thyroidectomy ) or Control Group (conventional open thyroidectomy). Measure the outcomes as following, early complication rate, life quality score, the number of dissected lymph nodes, the volume of residual gland, 3-year recurrence rate, operation duration, hospital stays, hospitalization expense, and inflammatory and immune response.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient's informed consent;
- •18 years old < age < 70 years old;
- •Papillary thyroid carcinoma (Bethesda grade V-VI) was pathologically diagnosed by fine needle aspiration biopsy of the primary thyroid tumor before surgery;
- •Color Doppler TI-RADS 4c-5 of primary thyroid tumor;
- •The preoperative clinical staging is T1, N0-1a, M0 (see diagnostic criteria for details; according to AJCC-8th TNM tumor staging);
- •It is expected that R0 surgical results can be obtained by performing single thyroid lobectomy and isthmus resection + ipsilateral central lymph node dissection;
- •Preoperative ASA score I-III.
排除标准
- •Pregnant or lactating patients;
- •Suffering from serious mental illness;
- •Preoperative imaging examinations suggest that the tumor is located in the thyroid isthmus or involves bilateral lobes;
- •Preoperative imaging examinations suggest the possibility of cervical lateral lymph node or distant metastasis;
- •Hashimoto's thyroiditis combined with hyperthyroidism or abnormal thyroid function;
- •History of neck surgery;
- •History of thyroid surgery (including ablation therapy for thyroid nodules);
- •Family history of thyroid cancer;
- •History of childhood ionizing radiation exposure;
- •History of other malignant diseases within 5 years;
- •A history of unstable angina or myocardial infarction within 6 months;
- •History of cerebral infarction or cerebral hemorrhage within 6 months;
- •History of continuous systemic corticosteroid therapy within 1 month;
- •Concurrent surgical treatment of other diseases is required;
- •Patients who are judged by the investigator to be unsuitable to participate in this trial.
研究组 & 干预措施
Study Group
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
干预措施: GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy) (Procedure)
Control Group
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
干预措施: COT(Conventional Open Thyroidectomy) (Procedure)
结局指标
主要结局
Life quality score (1 month after surgery)
时间窗: 1 month after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 month after surgery.
Life quality score (1 year after surgery)
时间窗: 1 year after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 1 year after surgery.
Early complication rate
时间窗: 30 days after surgery
Early complications include hemorrhage, surgical site infection, recurrent laryngeal nerve injury, hypoparathyroidism (PTH\<15pg/ml, or showing hypocalcification symptoms), chyle leakage, trachea injury, esophageal injury, etc.
Life quality score (6 months after surgery)
时间窗: 6 months after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 6 months after surgery.
Life quality score (3 days after surgery)
时间窗: 3 days after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 days after surgery.
Life quality score (3 months after surgery)
时间窗: 3 months after surgery
Use a modified Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QOL) to measure the quality of life 3 months after surgery.
次要结局
- The volume of residual gland(6 month after surgery)
- Inflammatory response(1 day after surgery)
- The number of dissected lymph nodes(3 days after surgery)
- Operation duration(Intraoperative)
- Hospitalization expense(3 days after surgery)
- 3-year recurrence rate(3 years after surgery)
- Hospital stays(3 days after surgery)