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临床试验/KCT0005570
KCT0005570尚未招募未知

The effect of postoperative supplemental parenteral nutrition (SPN) in gastric cancer patients who underwent gastrectomy: A multicenter prospective randomized controlled trial

Seoul National University Hospital0 个研究点目标入组 224 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
入组人数
224

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
18(Year) 至 o Limit(—)
性别
All

入选标准

  • (1) Patients who will undergo curative gastric cancer surgery (total gastrectomy, distal gastrectomy, proximal gastrectomy, and pylorus-preserving gastrectomy)
  • (2) A Malnourished patient who meets one or more of the following:
  • - BMI = 20.5 kg/m2: BMI will be measured 1 day before surgery
  • - Rapid weight loss (decreased by more than 5% in 2 months)
  • (3) Patients over 18 years of age
  • (4) Patients who are expected to receive PN for more than five days after surgery
  • (5) Patients who are able to eat orally, but cannot fulfill the recommened calorie requirement by oral intake alone.

排除标准

  • (1) In case that the patients have already provided parenteral nutrition prior to the consent of the study (oral diet prior to consent has nothing to do with study)
  • (2) In case that the patients need tube feeding
  • (3) Patients who are contraindicated to parenteral nutrition: heart failure (if the patient has current symptoms or receiving heart failure treatment, if ejection fraction(EF) was less than 40% in preoperative echocardiogram), Child-Pugh score C, renal failure (patient with 50% increased creatinine more than upper normal limit, patients currently undergoing renal replacement therapy), and pulmonary edema (appropriate chest X-ray signs for pulmonary edema), and the patient who suffered from allergie reaction to parenteral nutrition solutions.
  • (4) Patients who are not easily able to obtain venous pathways or are vulnerable to side effects due to venous pathways (e.g. increased infection risk due to immunosupressant status)
  • (5) Vulnerable subject (those who lack the decision making ability, pregnant women, or women who are planning to conceive)
  • (6) Other patients whom the investigator has determined to be inappropriate to participate in this study

研究者

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