Clinical Application of Preoperative Nutritional Support Package for Liver Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of complications at 30 days after surgery
研究概览
简要总结
Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection.
Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary liver cancer (including hepatocellular carcinoma, bile duct carcinoma, and mixed cell carcinoma)
- •No contraindications for surgery
- •Eastern Cooperative Oncology Group (ECOG) score of preoperative physical state <2 points
- •Preoperative liver function score Child-Pugh ≤ 6 points: total bilirubin ≤ 3.0 mg / dl, albumin ≥ 28 g / L, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal
- •Voluntarily enter the study and sign the informed consent form, and communicate well with the researcher
排除标准
- •Patients who took fish oil supplements within 3 weeks before the study began
- •Patients with severe nutritional risk: serious nutritional risk should be considered when combining any of the following conditions: weight loss > 10% within 6 months; digital pain score (NRS) score > 5 points; BMI <18.5 kg/m2 (all patients with severe nutritional risk undergo individualized supportive care);
- •Patients with malignant tumors in other parts
- •Patients who are pregnant or lactating
- •Patients with mental and neurological disorders who cannot cooperate with medical staff
- •Patients with severe diabetes or poor glycemic control
- •Patients cannot tolerate nutritional preparations
- •Other circumstances that the researcher considers inappropriate to participate in the study
结局指标
主要结局
Incidence of complications at 30 days after surgery
时间窗: up to 30 days after surgery
Postoperative complications were defined by Clavien-Dindo. Grade 1： Any deviation from the normal postoperative course without the need for pharmacologic treatment or surgical, endoscopic, and radiologic interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgetics, and diuretics, and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade 2： Requiring pharmacologic treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade 3： Requiring surgical, endoscopic, or radiologic intervention 3a： Intervention not under general anesthesia 3b： Intervention under general anesthesia Grade 4：Life-threatening complication (including CNS complications) requiring IC/ICU management. 4a： Single organ dysfunction (including dialysis) 4b： Multiple organ dysfunction Grade 5： Death as a result of complications
次要结局
- Postoperative hospital stay(up to 90 days after surgery)