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

Obama Kazutaka0 sites120 target enrollmentApril 13, 2023

Overview

No summary available.

Registry

who.int

Start Date

April 13, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Obama Kazutaka

•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\)