Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer: A Multi-centre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The changes of the level of circulating tumor cells in the peripheral blood
研究概览
简要总结
The purpose of this study is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood circulating tumor cells.
详细描述
Circulating tumor cells (CTCs) in the peripheral blood can be a biomarker to predict tumor recurrence and survival. Handling the tumor during a surgery may promote the release of CTCs into the bloodstream. Therefore, in a surgery of cancer, interruption of the vein before ligation of the artery may be justified. This multi-center randomized controlled trial is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood CTCs.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients with stage I-IV lung cancer eligible for surgery
- •Patients undergoing the completely thoracoscopic lobectomy
- •The nodule size was more than 2.5 cm
- •Patients consenting for intraoperative blood sampling
排除标准
- •Patients who underwent primary wedge resection and open lobectomy
- •Patients who received neoadjuvant therapy before surgery
结局指标
主要结局
The changes of the level of circulating tumor cells in the peripheral blood
时间窗: Intraoperative
The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the chest
次要结局
- 3-year Progression-Free-Survival(From date of the recruitment, assessed up to 36 months)
- Operative time(During the surgery)
- Blood loss(During the surgery)
- Morbidity(Within 30 days after surgery)
- Length of stay(From date of admission until the date of discharging or date of death from any cause in hospital, whichever came first, assessed up to 30 days)