Clinical Application of Nutrition Support Package Before Hepatectomy

NCT04218253 | Unknown

• 1 other identifier: 20191226
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Neoplasms; Nutrition Therapy; Hepatectomy

Keywords

Nutrition Therapy; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative hospital stay

  up to 90 days after surgery

Study Arms (2)

nutritional intervention

EXPERIMENTAL

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; Behavioral: Dietary mission

control group

OTHER

Dietary education was conducted according to preoperative nutritional requirements

Behavioral: Dietary mission

Interventions

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

nutritional intervention

Dietary mission BEHAVIORAL

Dietary education was conducted according to preoperative nutritional requirements

control group; nutritional intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Clinical diagnosis of primary liver cancer (including hepatocellular carcinoma, bile duct carcinoma, and mixed cell carcinoma)
• \. No contraindications for surgery
• \. Eastern Cooperative Oncology Group (ECOG) score of preoperative physical state \<2 points
• \. 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
• \. Voluntarily enter the study and sign the informed consent form, and communicate well with the researcher

You may not qualify if:

• \. Patients who took fish oil supplements within 3 weeks before the study began
• \. 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);
• \. Patients with malignant tumors in other parts
• \. Patients who are pregnant or lactating
• \. Patients with mental and neurological disorders who cannot cooperate with medical staff
• \. Patients with severe diabetes or poor glycemic control
• \. Patients cannot tolerate nutritional preparations
• \. Other circumstances that the researcher considers inappropriate to participate in the study

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University cancer Instituteand Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Amino Acids; Dietary Fiber

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kun Wang, Doctor

  Tianjin Medical University cancer Instituteand Hospital

  STUDY CHAIR

Central Study Contacts

Chunlei Li, Doctor

CONTACT

18622370261; lcltjmu507@163.com

Kun Wang, Doctor

CONTACT

23340123; lcltjmu507@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 6, 2020
• Study Start: October 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: June 30, 2022
• Last Updated: January 6, 2020

Record last verified: 2019-10

Locations

CN (1)