Safety and Efficacy of n-3 Fatty Acid-based Parenteral Nutrition in Patients With Obstructive Jaundice: A Propensity-matched Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Safety (complications)
研究概览
简要总结
The safety and efficacy of ω-3 fatty acid in patients with obstructive jaundice is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for patients with obstructive jaundice.
详细描述
Lipid emulsion enriched in n-3 fatty acid (FA) has been reported to improve postoperative recovery for surgical patients with biliary tract disease, and to improve laboratory and clinical outcomes. The role of it for postoperative patients with jaundice is not clear yet. The object of this research was to evaluate the safety and efficacy of n-3 fatty acid-based parenteral nutrition (PN) for patients with jaundice following Surgical procedure.
This cohort study was a pragmatic, retrospective, single center, matched, clinical trial from May 2014 to June 2017.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 diagnosis of obstructive jaundice must be clear (serum toal bilirubin >51.3umol/L & Imaging evidence), and the obstruction is located in the extrahepatic bile duct;
- •Duration of Jaundice is less than 2 weeks;
- •Nutritional support is needed
- •Nutritional support was administrated during the perioperative period;
- •Drainage treatment is effective.
排除标准
- •Contraindication for surgical procedure, including Child-Pugh Classification C, severe hemorrhagic disorders, gastrointestinal hemorrhage, acute infectious disease, active phase of chronic hepatitis B & C, severe circulatory disease, renal failure pre -operation, and other unknown cause;
- •Abandon treatment;
- •Length of stay in hospital <5 day;
- •Nutrition support <5 day;
- •Conservative treatment;
- •Incomplete data;
- •Allergic reactions against PN.
研究组 & 干预措施
trail cohort
n-3 FAs
干预措施: trail cohort (Drug)
control cohort
Structolipid
干预措施: control cohort (Drug)
结局指标
主要结局
Safety (complications)
时间窗: postoperative period（1 month ）
postoperative complications
velocity of the serum total bilirubin clearance
时间窗: postoperative period（1 month ）
the velocity of the serum TBIL clearance, which was calculated according to formula behind: (formal TB -TB of current) /time interval
次要结局
- kidney function(postoperative period（1 month ）)
研究者
Xiaoping Chen
Professor
Huazhong University of Science and Technology