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临床试验/NCT00809081
NCT00809081Unknown3 期

A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
3 期
入组人数
38
试验地点
1
主要终点
To evaluate the impact of early postoperative enteral feeding

研究概览

简要总结

Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.

  1. To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition
  2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy

详细描述

Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. The use of TPN significantly increases postoperative complications, especially those associate with infections. However, method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.

  1. To evaluate whether early enteral nutrition may be decreased the postoperative complications
  2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
  3. To determine the optimal method for postoperative nutritional support

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Periampullar carcinoma
  • Pancreaticoduonectomy
  • KARNOFSKY PERFORMANCE SCALE > 70
  • No history of Major operation

排除标准

  • Creatinine level>3mg/L
  • Ascitis/portal hypertension
  • New York Heart Association class>3
  • Preoperative Radiotheraly/chemotherapy
  • Unresectable primary cancer
  • Palliative surgery

结局指标

主要结局

To evaluate the impact of early postoperative enteral feeding

时间窗: Postoperative 21 days

次要结局

  • To evaluate the nutritional status(Postoperative 6 months)

研究者

申办方类型
Other

研究点 (1)

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