Uniportal Versus Triportal Thoracoscopic Lobectomy and Sublobectomy for Early Stage Lung Cancer: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 356
- 试验地点
- 6
- 主要终点
- Postoperative respiratory complications
研究概览
简要总结
Lung cancer is one of the most common cancers in the world. At present, surgical resection is still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Although uniportal VATS pulmonary resection has been proven to be effective in preventing postoperative morbidities, there is still no ample evidences to demonstrate that uniportal VATS pulmonary resection is equal or superior to traditional triportal thoracoscopic pulmonary resection. The purpose of this multicenter randomized controlled trial study is to compare the uniportal VATS with traditional triportal VATS pulmonary resection in postoperative complications, long-term survival, lymph node dissection and local recurrence.
详细描述
Lung cancer is one of the most common cancers in the world，especially in China, where the mortality ranked first in malignant tumors whether for males or females. At present, VATS (Video-assisted thoracoscopic surgery) lobectomy is still the "gold standard" for the treatment of lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Retrospective study in recent years showed that the postoperative complication rate is similar between uniportal thoracoscopic surgery and triportal thoracoscopic surgery. Meanwhile, the incision is more pleasing, the inflammatory response may be milder and the hospitalization time may be shorter in the uniportal thoracoscopic surgery. But until now there is no result of the randomized controlled study on the effectiveness and the prognosis between uniportal thoracoscopic surgery and triportal thoracoscopic surgery to support this conclusion. The objective of this multicenter randomized controlled trial study is to compare the postoperative complications, long-term survival, local recurrence, other perioperative variables such as conversion rate, blood loss, lymph nodes retrieved and postoperative hospital stay between the triportal VATS pulmonary resection and uniportal VATS pulmonary resection on early stage lung cancer.
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
- None
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
- •age≥18 years;
- •cT1- 2N0-1M0 diagnosed by chest CT, PET-CT before operation;
- •No severe comorbidity, can tolerate anesthesia;
- •ECOG PS scores≤2;
- •The patients sign informed consents by themselves.
排除标准
- •Inability to tolerance of tracheal intubation and general anesthesia;
- •ECOG PS scores>2;
- •Severe comorbidities including: Angina occurs in 3 months, uncontrolled hypertension, Congestive heart failure, a history of myocardial infarction in 6 months before admission, severe arrhythmia, severe liver, kidney or other metabolic diseases.
结局指标
主要结局
Postoperative respiratory complications
时间窗: 30 days after surgery
These respiratory complications involve respiratory distress or failure after the operation with continuation of mechanical ventilation, pulmonary atelectasis requiring sputum suction by bronchoscopy, pneumonia requiring specific antibiotics confirmed by thoracic X-ray or CT scan of the thorax and a positive sputum culture, and acute respiratory distress syndrome.
次要结局
- Local recurrence(3 years)
- Conversion rate(Intraoperation)
- Blood loss(Intraoperation)
- Long term survival(5 year)
- Lymph node dissection(Intraoperation)
研究者
Ju-Wei Mu
MD，PHD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences