Clinical Application of Nutrition Support Package Before Hepatectomy

Tianjin Medical University

Status: Unknown

Conditions: Liver Neoplasms; Hepatectomy; Nutrition Therapy

Treatments: Dietary Supplement: 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber; Behavioral: Dietary mission

Study type: Interventional

Funder types: Other

Identifiers

NCT04218253

20191226

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 2 patient groups

nutritional intervention

Experimental group

Description:

300 or 500 calories nutritional support before operation according to the level of malnutrition

Treatment:

Behavioral: Dietary mission

Dietary Supplement: 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber

control group

Other group

Description:

Dietary education was conducted according to preoperative nutritional requirements

Treatment:

Behavioral: Dietary mission