跳至主要内容
临床试验/jRCTs051230012
jRCTs051230012招募中不适用

Effects of the oral nutritional supplements (ONS) in postoperative patients with gastric cancer: a Multi-center, open-label parallel randomized controlled trial

未提供0 个研究点目标入组 120 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 85age old under(—)
性别
All

入选标准

  • Aged 18 - 85 years
  • ECOG Performance Status (PS) 0-2
  • Oral intake will be possible postoperatively
  • Pathologically diagnosed epithelial malignancy of stomach (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, etc.)
  • cStage I-IVa OR CY1P0
  • Scheduled for radical gastrectomy (distal gastrectomy, pylorus preserving distal gastrectomy, proximal gastrectomy, total gastrectomy)
  • Esophageal invasion length is within 2 cm or no esophageal invasion
  • Written informed consent was obtained

排除标准

  • First exclusion criteria
  • Combined resection of liver, pancreas, colorectum( D1 or over) or/and periaortic lymph node
  • Remnant gastric cancer
  • Diagnosis of double cancer
  • Allergic to Isocalclear (e.g. milk allergy)
  • Have advanced renal dysfunction (eGFR < 30 mL/min/1.73m2)
  • Treated with insulin or poorly controlled diabetes mellitus.
  • Have organ dysfunction requiring strict restriction of drinking water.
  • Have psychiatric disorders or psychiatric symptoms that interfere with daily life
  • Second exclusion criteria (postoperative criteria; POD5-7)
  • M1(no distant metastasis) or R2 resection (except for cy1)
  • Combined resection of liver, pancreas, or/and periaortic lymph node, esophagectomy
  • Unable to begin an oral diet
  • Gastrectomy was not performed
  • Allergic to Isocalclear (e.g. milk allergy)
  • Reefuse to participate in this study

结局指标

主要结局

-

The percentage of body weight loss from presurgical body weight to that at eight weeks after surgery

次要结局

  • Nutritional blood test findings(8 weeks, 6 months, and 12 months postoperatively)
  • Nutrient intakes(8 weeks postoperatively)
  • Quality of life(8 weeks, 6 months, and 12 months postoperatively)

研究者

发起方
未提供

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