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PROGAIN Trial in Gastric Cancer Surgery

RecruitingPhase 3Ages 19 Years - anyAllSoonchunhyang University Hospital
NCT07488611 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized study will evaluate whether protein-enriched parenteral nutrition improves early postoperative recovery in patients undergoing gastrectomy for gastric cancer. Participants will be assigned to receive either protein-enriched parenteral nutrition or standard parenteral nutrition during the perioperative period. The primary outcome is nitrogen balance on postoperative day 5. Secondary outcomes include postoperative complications, recovery of oral intake, and short-term changes in nutritional status and body composition.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study. Exclusion Criteria: * Patients with uncontrolled severe systemic diseases (e.g., decompensated diabetes, cerebrovascular event within the last 6 months, sepsis, heart failure). * Patients who have received intravenous parenteral nutrition within 7 days prior to randomization. * Patients with severe metabolic abnormalities confirmed by preoperative laboratory tests, including but not limited to: * Triglyceride \> 400 mg/dL * AST or ALT \> 3 x Upper Limit of Normal (ULN) * Total Bilirubin \> 3 x ULN * Serum Creatinine \> 2 x ULN * HbA1c \> 9.0% * Potassium \< 3.0 mEq/L or \> 6.0 mEq/L * Calcium \> 12.5 mg/dL * Sodium \> 155 mmol/L * Magnesium \> 3.0 mg/dL * Patients deemed inappropriate for participation in this clinical trial by the investigator.
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What it tests

  • Protein-enriched peripheral parenteral nutrition (Winuf A+ injection)
  • Standard peripheral parenteral nutrition (Winuf injection)
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Where

1 site
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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