A Prospective RCT Study of Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- The percentage of patients with one or more postoperative complications (time range: 90 days) was observed, and data were recorded during the hospital stay (expected average of 3 weeks) and during control visits 3 months postoperatively.
研究概览
简要总结
To prove that early enteral nutrition after pancreaticoduodenal operation is of great significance to improve the immune response, reduce the incidence of postoperative infection and other related complications, and shorten the length of hospital stay
详细描述
Arm A: Total parenteral nutrition. TPN also started from POD 1 and was delivered through a central venous catheter. Target energy of 1.5 amino acids/kg/day reached 30 kcal/kg/day.
Arm B: NJEEN was defined as providing at least 50% of the nutritional requirements through the nasojejunal tube prior to the 5th day after surgery (POD) and having no parenteral nutrition for 72 h or more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years old, gender is not limited;
- •All patients underwent pancreaticoduodenectomy;
- •ECOG 0 ~ 2 for physical condition score;
- •Imaging examination found pancreatic head, periampullary space, no distant metastasis and ascites;
- •No bone marrow dysfunction;
- •Those without obvious surgical contraindications;
- •Expected postoperative survival ≥3 months;
- •The study visit plan and other programme requirements are now available;
- •Voluntary participation and signing of informed consent.
排除标准
- •Patients with stage II and IV periampullary carcinoma of head of pancreas and periampullary carcinoma;
- •Active infected persons;
- •Distant metastasis or ascites were found in imaging examination;
- •Patients with serious impairment of heart, liver and kidney function (grade 3 to 4, ALT and/or AST more than 3 times the normal upper limit, Cr more than the normal upper limit);
- •patients with other malignant tumors or blood diseases;
- •Pregnancy, planned pregnancy and lactation female patients (urine HCG >02500 iu /L, diagnosed as early pregnancy);
结局指标
主要结局
The percentage of patients with one or more postoperative complications (time range: 90 days) was observed, and data were recorded during the hospital stay (expected average of 3 weeks) and during control visits 3 months postoperatively.
时间窗: 3month
The percentage of patients with one or more postoperative complications (time range: 90 days) was observed, and data were recorded during the hospital stay (expected average of 3 weeks) and during control visits 3 months postoperatively.
次要结局
未报告次要终点
研究者
Xian-Jun Yu
President of Pancreatic Cancer Institute
Fudan University