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临床试验/NCT01669356
NCT01669356已完成不适用

The Effect of Parenteral Nutrition Supplement Versus Enteral Nutrition Alone on Nutrition Status After Esophagectomy: A Prospective Randomized Controlled Trial

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2012年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
1
主要终点
postoperative laboratory parameters changes for nutrition assessment compared to preoperation

研究概览

简要总结

Malnutrition is common in esophagus cancer patients, especially after surgery therapy. Whether parenteral supplement with enteral nutrtion is benificial for patients after esophagectomy is controversial, when compared with enteral nutrition alone. In this study, the investigators are to examine the effect of enteral nutrition supplemented with parenteral nutrtion on nutrition status after esophagectomy.

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
Single (Participant)

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

入选标准

  • Clinical diagnosis of esophagus cancer
  • Undergo esophagectomy
  • Nasoenteral tube is placed or surgical jejunostomy is performed

排除标准

  • Contraindication for enteral nutrition or parenteral nutrition
  • Malnutrition before surgery ( BMI > 30 or < 18.5)
  • Hepatic dysfunction preoperatively
  • Renal dysfunction preoperatively
  • Infection before surgery
  • Usage of corticosteroid before surgery

结局指标

主要结局

postoperative laboratory parameters changes for nutrition assessment compared to preoperation

时间窗: from one day before surgery to the 7th postoperative day

plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts

postoperative body composition change compared to preoperation measurement

时间窗: from one day before surgery to the 7th postoperative day

postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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