Clinical Application of Preoperative Nutritional Support Package for Liver Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Neoplasms
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Incidence of complications at 30 days after surgery
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Incidence of complications at 30 days after surgery
Time Frame: 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
Secondary Outcomes
- Postoperative hospital stay(up to 90 days after surgery)