Hepatectomy, Liver Neoplasms, Nutrition Therapy
Conditions
Keywords
Nutrition Therapy, Hepatectomy
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.
Interventions
DIETARY_SUPPLEMENT300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber
300 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for Mild malnutrition, or 500 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for moderate to severe malnutrition. The degree of malnutrition is determined by Patient-Generated Subjective Global Assessment (PG-SGA).
BEHAVIORALDietary mission
Dietary education was conducted according to preoperative nutritional requirements
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Clinical diagnosis of primary liver cancer (including hepatocellular carcinoma, bile duct carcinoma, and mixed cell carcinoma) * 2\. No contraindications for surgery * 3\. Eastern Cooperative Oncology Group (ECOG) score of preoperative physical state \<2 points * 4\. 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 * 5\. Voluntarily enter the study and sign the informed consent form, and communicate well with the researcher
Exclusion criteria
* 1\. Patients who took fish oil supplements within 3 weeks before the study began * 2\. 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); * 3\. Patients with malignant tumors in other parts * 4\. Patients who are pregnant or lactating * 5\. Patients with mental and neurological disorders who cannot cooperate with medical staff * 6\. Patients with severe diabetes or poor glycemic control * 7\. Patients cannot tolerate nutritional preparations * 8\. Other circumstances that the researcher considers inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications at 30 days after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hospital stay | up to 90 days after surgery | from the date of the operation to the date of discharge |
Countries
China
Contacts
Primary ContactChunlei Li, Doctor
Backup ContactKun Wang, Doctor
Outcome results
None listed