Actively Recruiting
PROGAIN Trial in Gastric Cancer Surgery
Led by Soonchunhyang University Hospital · Updated on 2026-03-25
100
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
S
Soonchunhyang University Hospital
Lead Sponsor
J
JW Pharmaceutical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PROGAIN Trial in Gastric Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older scheduled to undergo gastric cancer surgery
- Patients who have provided written informed consent to participate in this study
You will not qualify if you...
- Patients with uncontrolled severe systemic diseases such as decompensated diabetes, cerebrovascular event within the last 6 months, sepsis, or heart failure
- Patients who have received intravenous parenteral nutrition within 7 days prior to randomization
- Patients with severe metabolic abnormalities confirmed by preoperative lab tests, including triglyceride > 400 mg/dL, AST or ALT > 3 x Upper Limit of Normal, total bilirubin > 3 x Upper Limit of Normal, serum creatinine > 2 x Upper Limit of Normal, HbA1c > 9.0%, potassium < 3.0 mEq/L or > 6.0 mEq/L, calcium > 12.5 mg/dL, sodium > 155 mmol/L, or magnesium > 3.0 mg/dL
- Patients deemed inappropriate for participation by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Soonchunhyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, South Korea, 31151
Actively Recruiting
Research Team
J
Jong Hyuk Yun, MD, PhD
CONTACT
H
Hyun Seob Shin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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