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临床试验/NCT03510429
NCT03510429Unknown不适用

Clinical Validation of Nutritional Supplements("Ketogenic Plus") Developed for Pancreaticobiliary Cancer Patients

Yonsei University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2018年4月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Food Intake Rate(%) for postoperative diet

研究概览

简要总结

Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets and products for pancreaticobiliary cancer patients. This time, newly developed ketogenic drink contain beefsteak mint.

The investigators expect that nutritional supplement for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (age more than 19)
  • Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
  • Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer

排除标准

  • Patient who denied clinical trial
  • Diabetes Mellitus(DM) patient with DM complication
  • Hyperlipidemia patient with vascular co-morbidity
  • Impaired renal function or renal failure (GFP<70%)
  • Poor nutritional status (PG-SGA grade C)

结局指标

主要结局

Food Intake Rate(%) for postoperative diet

时间窗: at the first follow up date (4 weeks after discharge)

Diet Intake Rate measured by dietary satisfaction questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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