Omega-3 Fatty Acid-Based Parenteral Nutrition Improves Postoperative Recovery for Cirrhotic Patients With Liver Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- complications (blood test for liver and renal function, urine output, postoperative complications)
研究概览
简要总结
The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for cirrhotic patients with liver cancer underwent hepatectomy..
详细描述
A new lipid emulsion enriched ω-3 fatty acid was manufactured, and was reported avoid hyperinflammatory situations in patients followed major surgery. However, the role of ω-3 fatty acid-based parenteral nutrition for postoperative patients with cirrhosis-related liver cancer is unclear. This study aims to evaluate the safety and efficacy of ω-3 fatty acid-based parenteral nutrition for cirrhotic patients with liver cancer followed hepatectomy.
A prospective randomized controlled clinical trial was conducted for cirrhotic patients with liver cancer underwent hepatectomy between March 2010 and September 2013 in the investigators institution. For postoperative parenteral nutrition, 20% Structolipid and 10% Omegaven were applied to the trial group, while only Structolipid to the control group for 5 consecutive days postoperatively.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The cirrhotic malnourished patients who were diagnosed as liver cancer preoperatively and underwent hepatectomy were consecutively enrolled.
排除标准
- •Contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C, indocyanine green retention rate at 15min (ICGR15)>30%(12), serum hepatitis B virus (HBV)-DNA>126 copies/ml and serum alanine aminotransferase (ALT) > 2×ULN, serum triglycerides>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause
- •Pregnancy
- •Age of<18y or>75y
- •Performed intraoperative ablation
- •Unresectable tumor during operation
- •Allergic reactions against fish or egg proteins
研究组 & 干预措施
Control group
For postoperative parenteral nutrition, only Structolipid applied for 5 consecutive days.
干预措施: Structolipid (Drug)
Trial group
For postoperative parenteral nutrition, Omega-3 Fatty Acid-Based Parenteral Nutrition (20% Structolipid and 10% Omegaven) were applied for 5 consecutive days.
干预措施: Omega-3 Fatty Acid-Based Parenteral Nutrition (Drug)
结局指标
主要结局
complications (blood test for liver and renal function, urine output, postoperative complications)
时间窗: 14 days postoperatively
blood test for liver and renal function, urine output, postoperative complications
hospital stay (time of hospital stay after surgery)
时间窗: 14 days postoperatively
the time of hospital stay after surgery
次要结局
- mortality(30 days postoperatively)
研究者
Xiaoping Chen
Professor
Huazhong University of Science and Technology