NCT01256034已完成4 期
Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Postoperative Infectious Complication
研究概览
简要总结
The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.
详细描述
The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after pancreaticoduodenectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.
Object of this study is to investigate the effects preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after pancreaticoduodenectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients underwent pancreaticoduodenectomy
排除标准
- •age younger than 18 years
- •ongoing infection
- •gastrointestinal obstruction
- •respiratory dysfunction
- •cardiac dysfunction
- •hepatic dysfunction
- •renal failure
- •history of recent immunosuppressive or immunological diseases
- •preoperative evidence of widespread metastatic disease
结局指标
主要结局
Postoperative Infectious Complication
时间窗: 30 days
次要结局
- Plasma IL-6, CRP, Th1/Th2 Balance(14 days)
研究者
Katsunori Furukawa
MD, PhD
Chiba University
研究点 (2)
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