A Prospective, Multi-center, Randomized Controlled Clinical Study of ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Total perioperative complication rates
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules. Participants will be divided into two group.One group will accepte treatment of ENB guided MWA combined with VATS,another will accepted sequential surgery.
详细描述
Lung cancer is one of the most common cancers and the leading cause of cancer-related death worldwide. With the improvement of people's health awareness and the wide application of LDCT and HRCT, the incidence of multiple primary lung cancer is increasing, especially the synchronous bilateral multiple primary pulmonary nodules are the difficulties in the treatment of pulmonary nodules. Bilateral sequential surgery is associated with higher intraoperative risks, higher rates of postoperative complications, and lower postoperative quality of life. At present, a small number of recent retrospective studies have shown that microwave ablation(MWA) guided by electromagnetic navigation bronchoscopy(ENB) combined with video-assisted thoracic surgery(VATS) treatment can effectively treat bilateral multiple primary pulmonary nodules, which not only has a low complication rate, but also can avoid secondary surgery.
Based on previous studies, the research plans to conduct a prospective, multi-center, randomized controlled study to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules, as well as its potential value as a new treatment option for these participants.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥18 years and ≤80 years;
- •The subjects are diagnosed synchronous bilateral multiple primary lung nodules by HRCT
- •The primary nodule is diagnosed as lung cancer by preoperative puncture or multidisciplinary discussion, which can be treated with radical surgery.
- •At least one secondary lesion (6mm≤diameter≤20mm, CTR<0.5) is contralateral to the primary nodule，which need treatment after multidisciplinary discussion
- •The ipsilateral secondary lesions can be treated by sublobar resection at the same time
- •ECOG PS score 0-1
- •The subjects participate voluntarily and sign a written informed consent;
排除标准
- •Patients have contraindications of surgery or anesthesia
- •Patients are unable to undergo bronchoscopy
- •A contralateral secondary lesion is unreachable during ENB planning
- •There are large blood vessels 2 mm near the contralateral secondary lesion
- •Patients have severe bleeding tendency and coagulation dysfunction which cannot be improved in a short time
- •Patients have interstitial pneumonia, pulmonary fibrosis, or severe emphysema
- •Patients have diseases,like severe anemia, dehydration, severe nutritional and metabolic disorders, which cannot be cured or improved in a short time
- •Patients have severe systemic infection and fever (>38.5°C)
- •Patients have other malignant tumors
- •Patients have participated in other clinical trials
- •Investigators consider the patient do not fit for the study
结局指标
主要结局
Total perioperative complication rates
时间窗: From the time of treatment to one month after operation
Complications refer to operation-related adverse events during and after the operation according to the Clavien-Dindo Classification, including pulmonary infection, Broncho-pulmonary hemorrhage, respiratory failure, pleural effusion, pneumothorax, persistent lung leak, arrhythmia, wound infection, death.
次要结局
- Objective response rate(ORR)(One and three months after ablation)
- Treatment-related side effects(From the time of treatment to one month after operation)
- Complications (grade ≥3)(One and three months after treatment)
- Lung function(One and three months and every year after treatment)
- The proportion of completed two operations(During operation, an average of 4 months)
- The overall cost of treatment(During hospitalization, an average of 2 weeks)
- The intraoperative blood loss(During operation)
- Postoperative hospital stay (days)(One months after treatment)
- Mortality within 30 days after surgery(One month after treatment)
- 3-year disease-free survival(DFS)(A follow-up period of 3 years)
- The operation time(During operation)
- Postoperative extubation time (days)(One months after treatment)
- Life expectancy(EORTC QLQ-LC29)(One and three months and every year after treatment)
研究者
Hecheng Li M.D., Ph.D
Professor
Ruijin Hospital