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
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