Clinical Application of Nutrition Support Package Before Hepatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-06-30

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.

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Detailed Description

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Conditions

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Liver Neoplasms Nutrition Therapy Hepatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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nutritional intervention

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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).

Dietary mission

Intervention Type BEHAVIORAL

Dietary education was conducted according to preoperative nutritional requirements

control group

Dietary education was conducted according to preoperative nutritional requirements

Group Type OTHER

Dietary mission

Intervention Type BEHAVIORAL

Dietary education was conducted according to preoperative nutritional requirements

Interventions

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300 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).

Intervention Type DIETARY_SUPPLEMENT

Dietary mission

Dietary education was conducted according to preoperative nutritional requirements

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No