Minimally Invasive Esophagectomy in Prone or Left Decubitus Position: A Prospective Randomized Clinical Trial From A Single Institution
试验速览
- 阶段
- 2 期
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Perioperative morbidity and mortality from the two groups
研究概览
简要总结
The purpose of this prospective randomized study is to compare clinical outcomes from two different patient position(prone vs left decubitus)with thoracoscopic esophageal mobilization in the procedure of Minimally Invasive Esophagectomy (MIE).
- Comparing morbidities from the two groups
- Comparing short-term quality of life from the two groups
- Comparing oncological results (3,5 year survival) from the two groups
详细描述
Thoracoscopic esophagectomy is routinely performed in two positions. The left decubitus position is the most commonly used position at most centers. However prone position is another alternative.
The left decubitus position is advocated for its the same position as the open procedure and easy to learn, as well as easy to emergent conversion to open thoracotomy .However, the disadvantage of this position is the need of lung retraction for better exposure and definitely one lung ventilation. They are regarded as potential causes leading lung injury.
Prone thoracoscopic esophageal mobilization has been advocated for its potential benefits of increased operative exposure, no lung retraction, avoid one lung ventilation, improved surgeon ergonomics. But it is difficult to make emergent conversion under this positon and not familiar with most thoracic or digestive surgeons. A longer learning curve may be needed.
A few publications have compared the two position with thoracoscopic mobilization of the esophagus in retrospective study of a small cohort. Until now, no prospective randomized study has been carried out in this field.
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
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical stage I/II esophageal cancer
- •normal blood test of basic metabolism panel
- •pulmonary function: FEV1 > 1.2L, FEV1% > 50%, DLCO > 50%
- •heart function: NY grade I and grade II
- •sign informed consent
排除标准
- •Patients who received neoadjuvant therapy
- •Mental disorders
结局指标
主要结局
Perioperative morbidity and mortality from the two groups
时间窗: 1 -5 years after surgery
次要结局
- short-term quality of life(postoperative 6 months and 1 year) between the two groups(1 year)
- 3-and 5-year survival rate between the two groups(1 - 5 years after surgery)
