NCT00746161已完成3 期
A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The %body weight ratio
研究概览
简要总结
The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method
详细描述
Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
- •Age 80 years or younger
- •No distant metastasis
排除标准
- •Carcinoma in the remnant stomach
- •Stage intravenous (IV)
- •History of laparotomy
- •History of serious heart disease
- •Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
- •Absence of informed consent
结局指标
主要结局
The %body weight ratio
时间窗: 12 months after operation
次要结局
- preoperative complication, PNI and QOL score(within one month, and 3 and 12months after operation)
研究者
研究点 (2)
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