The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Nitrogen Balance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study.
排除标准
- •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.
研究组 & 干预措施
Protein-enriched PPN
Patients assigned to this arm will receive a 4th-generation, protein-enriched peripheral parenteral nutrition (PPN). The intervention will be administered for a total of 6 days, starting from preoperative day 1 (POD -1) to postoperative day 5 (POD 5), excluding the day of surgery (POD 0). The daily infusion volume is dynamically individualized; it is titrated based on the patient's target nutritional requirements and their actual daily oral intake.
干预措施: Protein-enriched peripheral parenteral nutrition (Winuf A+ injection) (Drug)
Standard PPN
Patients assigned to this arm will receive a 3rd-generation, standard peripheral parenteral nutrition (PPN). The administration schedule is identical to the experimental arm (a total of 6 days, excluding POD 0). Similarly, the daily infusion volume is individualized and titrated according to the patient's actual oral caloric intake.
干预措施: Standard peripheral parenteral nutrition (Winuf injection) (Drug)
结局指标
主要结局
Nitrogen Balance
时间窗: 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)
次要结局
- Skeletal Muscle Index (Sarcopenia Assessment)(Baseline (preoperative), and 6 months postoperativel)
- Nutritional Status Assessed by GLIM Criteria(Baseline, 1 month, 3 months, and 6 months postoperatively)
- Modified Glasgow Prognostic Score (mGPS)(Baseline, 1 month, 3 months, and 6 months postoperatively)
- Complications(Up to 30 days postoperatively)
- Glycemic Control(Postoperative Day 1 to Day 5)
- Functional Recovery(Up to hospital discharge (expected average up to 7-10 days))
- Prognostic Nutritional Index (PNI)(Baseline, 1 month, 3 months, and 6 months postoperatively)
- C-Reactive Protein to Albumin Ratio (CAR)(Baseline, 1 month, 3 months, and 6 months postoperatively)
研究者
Geum Jong Song
Associate Professor of gastrointestinal surgery
Soonchunhyang University Hospital