The Study of Robotic-assisted Thoracoscopic Lobectomy Versus Video-assisted Thoracoscopic Lobectomy for Non-small Cell Lung Cancer (RVlob)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Lymph node counts
研究概览
简要总结
Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.
详细描述
Video-assisted thoracoscopic surgery (VATS) lobectomy is recommended for non small cell lung cancer (NSCLC) with surgical indications in China, its oncological long-term outcomes has been widely approved. As a new form of VATS, robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the 3D vision and flexible robot arm were helpful for surgeons to perform precise operations, and RATS was reported to bring extra benefits to patients. The surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. so we designed this randomized controlled trial to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.
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
- •surgical indication for lobectomy;
- •minimal invasive surgery;
- •ASA (American Society of Anesthesiologists) stage: I-III;
- •sign the informed consent. -
排除标准
- •benign tumor or nodule;
- •present of other malignancy;
- •preoperative chemotherapy, radiotherapy, targeted therapy. -
结局指标
主要结局
Lymph node counts
时间窗: postoperative in-hospital stay up to 30 days
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
3-year overall survival (OS)
时间窗: 3 year after surgery
OS at 3 year after surgery
次要结局
- margin state(postoperative in-hospital stay up to 30 days)
- operative time(postoperative in-hospital stay up to 30 days)
- length of stay (LOS)(postoperative in-hospital stay up to 30 days)
- 3-year disease-free survival (DFS)(3 year after surgery)
- 1-year overall survival (OS)(1 year after surgery)
- 1-year disease-free survival (DFS)(1 year after surgery)
- R0 rate(postoperative in-hospital stay up to 30 days)
- blood loss(postoperative in-hospital stay up to 30 days)
- conversion rate(postoperative in-hospital stay up to 30 days)
- operative accident event(postoperative in-hospital stay up to 30 days)
- 30-day mortality(postoperative in-hospital stay up to 30 days)
- quality of life (QOL) at 3 month(at 3 month after surgery)
- postoperative complications(postoperative in-hospital stay up to 30 days)
研究者
Hecheng Li M.D., Ph.D
Professor
Ruijin Hospital