VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung cancer-a Registry Study
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- morbidity and mortility rate
研究概览
简要总结
Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.
详细描述
Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major lung resection for lung cancer as a real-world study in china.This is a multicenter, prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung resection for early stage lung cancer. Patients will be followed up every 3 months for 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Preoperative criteria:
- •i) non-small cell lung cancer is suspected, ii) clinical stage I/II (3) Intraoperative criteria: i) Histologically confirmed NSCLC, ii) resected by VATS or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.
- •(4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
- •(5) No prior chemotherapy or radiation therapy for any malignant diseases. (6) Expected postoperative FEV1.0>=800 mL and PaO2>=65 torr. (7) Performance status of 0 or
- •(8) Sufficient organ functions. (9) Written informed consent.
排除标准
- •Active bacterial or fungous infection.
- •Simultaneous or metachronous (within the past 5 years) double cancers.
- •Women during pregnancy or breast-feeding.
- •Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
- •Systemic steroids medication.
- •Uncontrollable diabetes mellitus.
- •Uncontrollable hypertension.
- •History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
结局指标
主要结局
morbidity and mortility rate
时间窗: 3 moths
perioperative complications and death rates of the group
次要结局
- Disease-free survival(3y)
- Rate of loco-regional and systemic recurrence(3y)
- Pulmonary function(6 months after surgery)
- Postoperative hospital stay.(3 months postoperatively)
- Postoperative drainage duration(3 months postoperatively)
- overall survival(3 months postoperatively)
- converted rate(3 months)
研究者
Jun Wang
Principal Investigator, Clinical Professor
Peking University People's Hospital