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临床试验/NCT01642875
NCT01642875Unknown4 期

Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
96
试验地点
2
主要终点
Frequency of delayed gastric emptying

研究概览

简要总结

Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative complications often preclude or delay adequate oral nutrition and nutritional support may be required. However, the role of perioperative nutritional supplementation in well-nourished patients remains controversial.

The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy.

96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). 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 PerOs group will receive oral diets beginning from the 2nd postoperative day and oral intake will be advanced as tolerated.

详细描述

Background & aim: Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative complications often preclude or delay adequate oral nutrition and nutritional support may be required. However, the role of perioperative nutritional supplementation in well-nourished patients remains controversial. There are not any standard protocols for nutritional support after major upper gastrointestinal surgery in these patients and postoperative nutritional regimens depend mainly upon surgeon's or center preference.

Patients undergoing pancreatoduodenectomy often begin oral intake a week after operation and enteral or parenteral nutrition is used to cover the daily caloric requirements during this period, although their role still remains questionable. The safety of early oral nutrition has been confirmed in the majority of gastrointestinal procedures. However, pancreatic surgeons are quite reluctant to advance oral diet within the first postoperative week after pancreatoduodenectomy due to fear of anastomosis breakdown or delayed gastric emptying syndrome. These two postoperative nutritional regimens, early oral vs. early enteral nutrition, have not been sufficiently evaluated in a prospective, randomized study.

Material and Methods

96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive standard enteral diet administered through a nasojejunal tube. The enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and oral intake will be advanced as tolerated.

Purpose: The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary periampullary tumor
  • R0, R1 resection
  • Chronic pancreatitis requiring pancreatoduodenectomy

排除标准

  • Metastatic tumor
  • Locally unresectable tumor
  • Previous gastric resection
  • Age under 18 years
  • Preoperative complete parenteral or enteral feeding
  • Immunosuppressive therapy before operation
  • Severe malnutrition
  • Lack of the patient's consent for the trial participation, feeding tube insertion or epidural analgesia

结局指标

主要结局

Frequency of delayed gastric emptying

时间窗: 30 days after operation

次要结局

  • Overall morbidity rate(60 days after operation)
  • Time to resolution of paralytic ileus(7 days after operation)
  • Postoperative hospital stay length(60 days after operation)
  • Time to full oral nutrition(60 days after operation)
  • Perioperative mortality rate(60 days after operation)
  • Rehospitalization rate(30 days after discharge)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (2)

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