Impact of the Sequence of Vessel Interruption During Major Pulmonary Resections for Non-small Cell Lung Cancer Based on Circulating Tumor Cells Detection Peroperatively in the Tumor-draining Pulmonary Vein: a Randomized Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in CTC density
研究概览
简要总结
This study aims to define the impact of the sequence of vessel interruption on change in CTC and CTC clusters density in the tumor-draining pulmonary vein between the period before surgical manipulation and before tumor-draining vein interruption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC with preoperative pathological evidence,
- •Pure solid nodule or part-solid (>50%) ground glass nodule on CT scan
- •Clinical stage tumor-1 to 3, clinical stage node-0, clinical stage metastasis-0, (except clinical stage tumor-3 for chest wall, pericardium or phrenic nerve invasion)
- •Video-assisted thoracoscopic lobectomy or bi-lobectomy
排除标准
- •Pneumonectomy, segmentectomy, non anatomic resection
- •History of thoracic surgery on the same side
- •Necessity to perform a non-anatomic resection in addition to the lobectomy
- •No preoperative histological diagnosis
- •Pure ground glass nodule on CT scan
- •Clinical stage tumor-4 or 3 for chest wall, pericardium or phrenic nerve invasion
- •Clinical stage node ≥1
- •Neoadjuvant therapy
- •Second cancer or cancer in the past 5 years
- •First approach through thoracotomy with ribs spreading
- •Pregnancy, <18 years of age
- •Pulmonary adherences/symphysis found during surgery (impossible to perform the first blood sample without lung manipulation)
研究组 & 干预措施
Vein first
Tumor-draining pulmonary vein is interrupted first and before any surgical manipulation.
干预措施: Vein interruption before any other surgical manipulation (Procedure)
Arteries before vein
Lobar arteries (+/- bronchus and inter-lobar fissures) are interrupted before tumor-draining pulmonary vein.
干预措施: Arteries interruption before vein interruption (Procedure)
结局指标
主要结局
Changes in CTC density
时间窗: Within 96 hours after surgery
Changes in CTC count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).
Changes in CTC clusters density
时间窗: Within 96 hours after surgery
Changes in CTC clusters (or CTC micro-emboli defined as ≥3 contiguous CTC) count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).
次要结局
- Disease free survival(2 years and 5 years after surgery)
- Overall survival(2 years and 5 years after surgery)
研究者
Massimo Conti
Medical Doctor
Laval University