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Clinical Application of Nutrition Support Package Before Hepatectomy

Primary Purpose

Liver Neoplasms, Nutrition Therapy, Hepatectomy

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

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

Dietary mission

About this trial

This is an interventional prevention trial for Liver Neoplasms focused on measuring Nutrition Therapy, Hepatectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Tianjin Medical University cancer Instituteand HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

nutritional intervention

control group

Arm Description

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

Dietary education was conducted according to preoperative nutritional requirements

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative hospital stay

from the date of the operation to the date of discharge

Full Information

NCT ID

NCT04218253

First Posted

December 29, 2019

Last Updated

January 2, 2020

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04218253

Brief Title

Clinical Application of Nutrition Support Package Before Hepatectomy

Official Title

Clinical Application of Preoperative Nutritional Support Package for Liver Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Neoplasms, Nutrition Therapy, Hepatectomy

Keywords

Nutrition Therapy, Hepatectomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nutritional intervention

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

Other

Arm Description

Dietary education was conducted according to preoperative nutritional requirements

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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

Behavioral

Intervention Name(s)

Dietary mission

Intervention Description

Dietary education was conducted according to preoperative nutritional requirements

Primary Outcome Measure Information:

Title

Incidence of complications at 30 days after surgery

Description

Time Frame

up to 30 days after surgery

Secondary Outcome Measure Information:

Title

Postoperative hospital stay

Description

from the date of the operation to the date of discharge

Time Frame

up to 90 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chunlei Li, Doctor

Phone

18622370261

lcltjmu507@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kun Wang, Doctor

Phone

23340123

Ext

1155

lcltjmu507@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kun Wang, Doctor

Organizational Affiliation

Tianjin Medical University cancer Instituteand Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Tianjin Medical University cancer Instituteand Hospital

City

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kun Wang

Phone

23340123

Ext

1155

lcltjmu507@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Clinical Application of Nutrition Support Package Before Hepatectomy

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