Effect of Enteral Nutrition on Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incident rate of delayed gastric emptying
研究概览
简要总结
Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer. PD is still associated with a relatively a high incidence of delayed gastric emptying. And, there are no acknowledged strategies to avoid DGE. Several feeding strategies have been investigated to cope with this problem. However, there is still no consensus concerning the best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early enteral nutrition or total parenteral nutrition.
Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural control). The EN group will receive standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The Saline group will receive saline administered through a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be restricted in all three group.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent selective pancreaticoduodenectomy Patients ≥18 years old and ≤80 years old Having given written informed consent
排除标准
- •Previous gastric resection or intestinal reconstruction Preoperative complete parenteral or enteral feeding ASA score ≥4 Pregnant women Severe malnutrition Patient who cannot give written informed consent.
研究组 & 干预措施
Early enteral nutrition
Nasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
干预措施: Early enteral nutrition (Other)
Early enteral nutrition
Nasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
干预措施: nasojejunal tube insertion (Device)
Early enteral nutrition
Nasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
干预措施: Oral intake (Other)
Saline Group
Nasojejunal tube insertion was done intraopratively. Saline was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
干预措施: Saline (Other)
Saline Group
Nasojejunal tube insertion was done intraopratively. Saline was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
干预措施: nasojejunal tube insertion (Device)
ERAS Group
Nasojejunal tube insertion was done intraopratively. None was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
干预措施: nasojejunal tube insertion (Device)
ERAS Group
Nasojejunal tube insertion was done intraopratively. None was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
干预措施: Oral intake (Other)
结局指标
主要结局
Incident rate of delayed gastric emptying
时间窗: 30 days
DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS.
次要结局
- Infectious complications(30 days)
- Overall morbidity rate(30 days)
- Rehospitalization rate(60 days)
- Hemorrhagic complications(30 days)
- Postoperative hospital stay length(60 days)
- Postoperative mortality rate(30 days)
- Pancreatic fistulas(30 days)
- Maximum Plasma Concentration fasting plasma GLP-1 level(Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7)
- Evaluation of the severity of the complications(30 days)
研究者
Yi Miao, Prof.
Director of Pancreas Center
Nanjing Medical University