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

Obama Kazutaka0 个研究点目标入组 120 人开始时间: 2023年4月13日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

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

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

发起方

Obama Kazutaka