Feasibility of Assisted-VATS(Video-Assisted Thoracoscopic Surgery) Sleeve Lobectomy for Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer. (Success is defined as assisted-VATS sleeve lobectomy without conversion).
研究概览
简要总结
The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.
详细描述
Sleeve lobectomy is removal of a portion of a main stem bronchus in continuity with the adjacent lobe or bilobe followed by end-to-end bronchial anastomosis. The first reported bronchial sleeve resection was performed in 1947 at the Brompton Hospital in London, England, by Sir Clement Price Thomas. Whether sleeve resection is radical enough and indicated for patients who could tolerate pneumonectomy continues to be debated, although many recent reports have suggested that sleeve resection can achieve adequate curability rates. However, sleeve lobectomy has a definite role in the surgical management of lung cancer for patients whose pulmonary reserve is considered inadequate to permit pneumonectomy, and should be used anytime it is possible to achieve a margin-negative (R0) resection.
Although video-assisted thoracic surgery (VATS) is regarded as a minimally invasive procedure with good long-term survival results, many surgeons think that VATS is too complex and has too many technical limitations to be applied to bronchoplasty. Therefore, there are few reports in the literature of VATS bronchoplasty for lung cancer. The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
- •Patients with central tumors located at the origin of a lobar bronchus.
- •ECOG performance status 0-1
- •Hematopoietic: WBC at least 4,000/mm^3; Platelet count at least 100,000/mm^3
- •Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
- •Renal: Creatinine clearance greater than 60 ml/min
- •Cardiovascular: Cardiac function normal
排除标准
- •Severe complications or infections
- •Pregnant or breast-feeding women
- •Clinically significant heart disease
- •Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- •Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
结局指标
主要结局
If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer. (Success is defined as assisted-VATS sleeve lobectomy without conversion).
时间窗: 3 months
次要结局
- To evaluate the intraoperative(surgical duration, estimated blood loss), postoperative variables(mortality, morbidity, chest tube drainage duration, hospital stay), and 5-year survival rates.(3 months)