Clinical Application of Nutrition Support Package Before Hepatectomy

Not Applicable

• Conditions: Hepatectomy; Liver Neoplasms; Nutrition Therapy
• Interventions: Dietary Supplement: 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber; Behavioral: Dietary mission

• Registration Number: NCT04218253
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-01
• Study First Submitted: 2019-12-29
• Study First Submitted QC: 2020-01-02
• Last Update Submitted: 2020-01-02
• Study First Posted: 2020-01-06
• Last Update Posted: 2020-01-06
• Primary Completion: 2021-09-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nutritional intervention	300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber	300 or 500 calories nutritional support before operation according to the level of malnutrition
nutritional intervention	Dietary mission	300 or 500 calories nutritional support before operation according to the level of malnutrition
control group	Dietary mission	Dietary education was conducted according to preoperative nutritional requirements

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Postoperative hospital stay	up to 90 days after surgery	from the date of the operation to the date of discharge

Trial Locations

Locations (1)

Tianjin Medical University cancer Instituteand Hospital; 🇨🇳 Tianjin, China