Clinical Application of Nutrition Support Package Before Hepatectomy

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Application of Preoperative Nutritional Support Package for Liver Cancer

Conditions
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Liver Neoplasms, Nutrition Therapy, Hepatectomy

Intervention / Treatment
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* Dietary Supplement: 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber
* Behavioral: Dietary mission


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nutritional intervention<br>300 or 500 calories nutritional support before operation according to the level of malnutrition | Dietary Supplement: 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber<br>* 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).<br>Behavioral: Dietary mission<br>* Dietary education was conducted according to preoperative nutritional requirements<br>|
| Other: control group<br>Dietary education was conducted according to preoperative nutritional requirements | Behavioral: Dietary mission<br>* Dietary education was conducted according to preoperative nutritional requirements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications at 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 | up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hospital stay | from the date of the operation to the date of discharge | up to 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition Therapy, Hepatectomy