Interest of Preoperative Immunonutrition in Liver Resection for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 2
- 主要终点
- Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN
研究概览
简要总结
To study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.
详细描述
Perioperative immunonutrition has been developed to improve the immuno metabolic host response and outcome in postoperative period and has been proven to be beneficial in reducing significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors. To date, the effects of preoperative oral immunonutrition (ORAL IMPACT) in non cirrhotic patients undergoing liver resection for cancer are unknown. The purpose of this study is to determine whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for malignant tumours.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18 years
- •Non cirrhotic patient
- •Elective liver surgery for cancer (primary or secondary malignant tumours)
- •Hepatectomy including at least 1 segment or 3 wedge resections
排除标准
- •Liver resection for benign lesions
- •Liver resection associated with biliary tract surgery
- •Liver resection associated with gastro-intestinal surgery
- •Cirrhosis, defined by transient elastography (Fibroscan®) or by liver biopsy
- •Renal failure
- •Pregnancy or nursing women
- •History of hypersensitivity or allergy to arginine, omega-3 fatty acids, or nucleotides
- •Inability to take oral nutrition
- •Mental condition rendering the subject unable to understand the nature, end-points and consequences of the trial
研究组 & 干预措施
Impact control
ORAL IMPACT Powder 74g within 250ml of water, 3 times per day during 7 days before surgery
干预措施: Oral immunonutrition (Dietary Supplement)
Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Overall complications classified in grade 2-3-4 or 5 by DINDO-CLAVIEN
时间窗: In the first 30 postoperative days after Liver surgery
次要结局
- Length of hospital stay(30 days after surgery)