PROGAIN Trial in Gastric Cancer Surgery

Официальное название

The PROGAIN Trial : A Randomized Study of Protein-enriched Parenteral Nutrition on Nitrogen Balance and Recovery in Perioperative Gastric Cancer Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Protein-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.
• Препарат Standard peripheral parenteral nutrition (Winuf injection)
  A conventional, standard 3-chamber peripheral parenteral nutrition formulation (Winuf injection; JW Pharmaceutical). Administered intravenously.

Первичные конечные точки

• Nitrogen Balance [Срок оценки: Postoperative Day 5 (POD 5)]

Вторичные конечные точки (8)

• Skeletal Muscle Index (Sarcopenia Assessment) [Срок оценки: Baseline (preoperative), and 6 months postoperativel]
• Nutritional Status Assessed by GLIM Criteria [Срок оценки: Baseline, 1 month, 3 months, and 6 months postoperatively]
• Complications [Срок оценки: Up to 30 days postoperatively]
• Glycemic Control [Срок оценки: Postoperative Day 1 to Day 5]
• Functional Recovery [Срок оценки: Up to hospital discharge (expected average up to 7-10 days)]
• Prognostic Nutritional Index (PNI) [Срок оценки: Baseline, 1 month, 3 months, and 6 months postoperatively]
• C-Reactive Protein to Albumin Ratio (CAR) [Срок оценки: Baseline, 1 month, 3 months, and 6 months postoperatively]
• Modified Glasgow Prognostic Score (mGPS) [Срок оценки: Baseline, 1 month, 3 months, and 6 months postoperatively]

Критерии участия

Критерии включения

• Adults aged 19 years or older scheduled to undergo gastric cancer surgery. - Patients who have provided written informed consent to participate in this study.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Soonchunhyang University Cheonan Hospital — Cheonan

Идентификаторы

NCT: NCT07488611 · 2025-11-024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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