Comparison of Safety and Efficacy Among "3-Hole" Subxiphorid Approach, Trans Sternal Approach and VATS in Surgical Treatment of Anterior Mediastinal Tumor
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Duration of operation
研究概览
简要总结
Surgery plays an important role in the treatment of anterior mediastinum disease. The major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is rarely adopted because of its restricted visual field. The cervical combined mid-sternal approach have a broader field of vision, given this advantage, the surgeon can remove the thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is much larger, and the postoperative complication is also a serious problem. The video-assisted thoracoscope is often adopted by left or right approach, this minimally invasive procedure can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators designed a new method named "3-Hole" subxiphoid approach. This study is designed to compare the safety and validity between this new method and others.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
- •Masaoka stagingⅠ-Ⅱ
- •Thymoma without MG
- •Mass diameter <10cm
- •Inform Consent Form is signed
排除标准
- •Unable to tolerate surgery
- •myasthenic crisis
- •Masaoka staging Ⅲ-Ⅳ
- •Patients who have undergone previous surgery or radiotherapy
- •pregnancy , breastfeeding or younger than 18 years old
结局指标
主要结局
Duration of operation
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Rate of conversions to thoracotomy
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Only in "3-Hole" subxiphorid group and VATS group
Amount of bleeding
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Measured by the difference between the wet weight and dry weight of surgical gauze
Mortality rate
时间窗: up to 10 years
Death caused by operation or complications
Overall survival
时间窗: up to 10 years
From randomization to any cause of death
Quality of life
时间窗: up to 10 years after operation
Measured by EORTC QLQ-C30 (version 3) scale
Number of Participants with Adverse Events
时间窗: up to 8weekss afte operation
次要结局
未报告次要终点
研究者
Yongan Zhou
Associate Professor
Tang-Du Hospital
