Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center
试验速览
- 阶段
- 2 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Health related quality of life
研究概览
简要总结
The purpose of this multi-center prospective cohort study is to study the health-related quality of life (HRQL) together with other outcomes of patients with esophageal cancer after surgery in China.
详细描述
- To study the influence of health-related quality of life of patients with esophageal cancer before and after surgery.
- To compare the impact of different procedures on the the health-related quality of life of patients with esophageal cancer.
- To compare morbidities and oncological results(3,5- year survival) from different procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
排除标准
- •Mental disorders
- •Combination with other cancers
- •With a previous history of thoracic or ventral surgery
研究组 & 干预措施
MIE Group
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
干预措施: MIE (Procedure)
Three-incision esophagectomy group
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
干预措施: Three-incision thoracotomy (Procedure)
Ivor-Lewis esophagectomy group
The patients in this group would underwent Ivor-Lewis esophagectomy
干预措施: Ivor-Lewis esophagectomy (Procedure)
Sweet esophagectomy group
The patients in this group would underwent Sweet esophagectomy.
干预措施: Sweet esophagectomy (Procedure)
结局指标
主要结局
Health related quality of life
时间窗: postoperative 2 year
Health related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18)
次要结局
- Morbidity Mortality Survival rate(5 years)