Stomach (Gastric) Cancer
Conditions
Keywords
Parenteral Nutrition, Gastrectomy, Nitrogen Balance, Protein enriched, Perioperative nutrition, Enhanced Recovery After Surgery, Stomach Neoplasms
Brief summary
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.
Detailed description
Gastrectomy for gastric cancer induces a significant postoperative catabolic state, making adequate protein delivery crucial for optimal tissue healing and recovery. In the modern era of Enhanced Recovery After Surgery (ERAS) protocols, the routine use of central venous catheters for total parenteral nutrition (CPN) is heavily discouraged due to its invasiveness, infection risks, and hindrance to early mobilization. Consequently, Supplemental Parenteral Nutrition (SPN) via a peripheral route has emerged as the preferred strategy to bridge the nutritional gap when early oral intake is insufficient. However, traditional standard peripheral parenteral nutrition (PPN) is inherently limited by osmolarity constraints to prevent peripheral phlebitis. This physical restriction often results in a critically inadequate supply of amino acids, failing to meet the heightened protein demands required to reverse acute postoperative catabolism and prevent rapid muscle depletion. Recently, novel protein-enriched peripheral parenteral formulations have been developed to overcome this exact limitation, allowing for a higher, optimal amino acid load to be delivered safely via peripheral veins. The PROGAIN trial aims to evaluate the clinical impact of these advanced formulations. The investigators hypothesize that utilizing protein-enriched PPN, compared to standard PPN, will effectively blunt the catabolic response, significantly improve postoperative nitrogen balance, and facilitate earlier functional recovery in gastric cancer patients without compromising the principles of the ERAS pathway.
Interventions
DRUGProtein-enriched peripheral parenteral nutrition (Winuf A+ injection)
A novel, high-amino acid peripheral parenteral nutrition formulation (Winuf A+ injection; JW Pharmaceutical) designed to provide optimal protein delivery with lower glucose load. Administered intravenously.
DRUGStandard peripheral parenteral nutrition (Winuf injection)
A conventional, standard 3-chamber peripheral parenteral nutrition formulation (Winuf injection; JW Pharmaceutical). Administered intravenously.
Sponsors
Soonchunhyang University Hospital
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nitrogen Balance | Postoperative Day 5 (POD 5) | Change in nitrogen balance, assessed by measuring 24-hour urinary urea nitrogen excretion and calculating total daily protein intake (from both oral diet and parenteral nutrition) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal Muscle Index (Sarcopenia Assessment) | Baseline (preoperative), and 6 months postoperativel | Quantitative changes in skeletal muscle mass evaluated using the Skeletal Muscle Index (SMI). SMI is a continuous physiological measurement derived from cross-sectional imaging (such as abdominal computed tomography) and/or bioelectrical impedance analysis (BIA). Because it is a continuous physiological variable, there are no predefined minimum or maximum values on a scale. Higher SMI values indicate greater skeletal muscle mass, representing a better clinical outcome (prevention of muscle depletion). |
| Nutritional Status Assessed by GLIM Criteria | Baseline, 1 month, 3 months, and 6 months postoperatively | Change in nutritional status evaluated using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Participants will be categorized into normal nutritional status, moderate malnutrition, or severe malnutrition. This is a categorical assessment, not a numerical scale with minimum or maximum values. The "normal nutritional status" category represents the best clinical outcome, while "severe malnutrition" represents the worst. |
| Complications | Up to 30 days postoperatively | Rate of postoperative complications classified as Clavien-Dindo grade 2 or higher, specifically monitoring for delayed gastric emptying (DGE) and infectious complications (surgical site infection, pneumonia). The Clavien-Dindo classification is an ordinal scale used to grade surgical complications. The scale ranges from Grade I (minimum value, mild complication) to Grade V (maximum value, death of a patient). A higher grade indicates a more severe complication, representing a worse clinical outcome. |
| Glycemic Control | Postoperative Day 1 to Day 5 | Frequency of hyperglycemic events, defined as plasma glucose levels of 180 mg/dL or higher, during the parenteral nutrition administration period. |
| Functional Recovery | Up to hospital discharge (expected average up to 7-10 days) | Recovery of Oral Intake, Length of Hospital Stay |
| Prognostic Nutritional Index (PNI) | Baseline, 1 month, 3 months, and 6 months postoperatively | Change in the Prognostic Nutritional Index (PNI), calculated based on serum albumin concentration and total peripheral lymphocyte count. Because it is a continuous physiological calculated index, there are no predefined minimum or maximum values on a scale. Higher PNI values indicate better nutritional and immunological status, representing a better clinical outcome. |
| C-Reactive Protein to Albumin Ratio (CAR) | Baseline, 1 month, 3 months, and 6 months postoperatively | Change in the C-Reactive Protein to Albumin Ratio (CAR), calculated by dividing the serum C-reactive protein (CRP) level by the serum albumin level. This is a continuous physiological ratio, thus there are no predefined minimum or maximum values. Lower CAR values indicate lower systemic inflammation and better nutritional status, representing a better clinical outcome. |
| Modified Glasgow Prognostic Score (mGPS) | Baseline, 1 month, 3 months, and 6 months postoperatively | Change in the modified Glasgow Prognostic Score (mGPS), an inflammation-based prognostic score based on serum CRP and albumin thresholds. The mGPS is an ordinal scale with predefined values of 0, 1, or 2 (minimum value: 0, maximum value: 2). A lower score indicates a lower level of systemic inflammation, representing a better clinical outcome (0 is the best outcome, 2 is the worst outcome). |
Countries
South Korea
Contacts
CONTACTJong Hyuk Yun, MD, PhD
CONTACTHyun Seob Shin
PRINCIPAL_INVESTIGATORGeum Jong Song, MD, PhD
Soonchunhyang University Hospital
Outcome results
None listed