Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 14
- 主要终点
- Hospital cost
研究概览
简要总结
The purpose of this study is to modify the surgical technique of VATS (video-assisted thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer.
详细描述
VATS (video-assisted thoracoscopic surgery) lobectomy is a relatively new minimally invasive surgical treatment for early-stage non-small cell lung cancer (NSCLC), associated with low morbidity and mortality and effective oncologic results over the standard thoracotomy. However, this surgical procedure has not spread widely in china for several reasons. First , VATS surgery cost more than thoracotomy for thoracoscopic staples; second, the procedure of VATS lobectomy may be more difficult in china as the lack of VATS surgical equipments adjusted for smaller thoracic cavity of chinese, and more common adhesive and calcified lymph nodes due to infection and tuberculosis; Third, the surgical levels of VATS lobectomy are far from equal in china, and the Continuing Medical Education training programs of thoracoscopic surgery seem to be less efficient without major criterion.
The purpose of this study is to modify the surgical technique of VATS (video-assisted thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer, to examine the feasibility of VATS lobectomy performed by less staples, and to evaluate the feasibility of VATS lobectomy performed by modified surgical equipments designed according to the experience of chinese lobectomy surgery, and to generate a chinese standard operative procedure of VATS lobectomy for technique learning and spread. The investigators will intend to recruit 250 patients each group, for 4 groups. Group A(open group) will undergo radical lobectomy via thoracotomy approach. Group B(standard VATS group) will undergo lobectomy via standard VATS approach introduced. Group C(less staples group) will undergo lobectomy via VATS approach with staples limitation. Group D(modified equipments group) will undergo lobectomy via VATS approach using VATS surgical equipments designed according to the experience of chinese lobectomy surgery. The investigators will compare two groups of patients as followed: A vs. B, B vs. C, B vs. D.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •clinically diagnosed with stage I to stage II peripheral non-small cell lung cancer suitable for lobectomy.
- •signed informed consent from patient or legal representative, and allowed adequate follow-up.
- •operators must have experience of VATS lobectomy for more than 50 cases.
排除标准
- •pregnant or breastfeeding women.
- •severe complications or infections.
- •no prior chemotherapy or radiotherapy for this malignancy.
- •medical history of mediastinal or hilar lymphadenopathy.
- •current participation in another study involving an investigational device or drug.
结局指标
主要结局
Hospital cost
时间窗: 6 weeks after surgery.
less staples group vs.standard VATS group
Operative time
时间窗: 6 weeks after surgery.
For modified equipments group, if the operative time is significantly less than stand VATS group, the equipments is considered as feasible.
Survival time
时间窗: 5 years
overall survival rate(1-year, 3-year,5-year)will be analysed by the survival times of the follow-up patients.
次要结局
- Pain Scale Evaluation(6 weeks after surgery)
- Quality of life(1 year)
- Conversion rate(6 weeks after surgery)
- Disease-free survival time(5 years after surgery)
- Postoperative morbidity(3 months after surgery)
- Postoperative drainage duration(3 months after surgery)
- Postoperative hospital stay(3 months after surgery)
- Blood loss(3 months after surgery)
- Postoperative mortality(3 months after surgery)
研究者
Jun Wang
prof. Dr.
Peking University People's Hospital