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Clinical Application of Nutrition Support Package Before Hepatectomy

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ClinicalTrials.gov Identifier: NCT04218253
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Liver Neoplasms Nutrition Therapy Hepatectomy Dietary Supplement: 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber Behavioral: Dietary mission Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Clinical Application of Preoperative Nutritional Support Package for Liver Cancer
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nutritional intervention
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
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).

Behavioral: Dietary mission
Dietary education was conducted according to preoperative nutritional requirements

control group
Dietary education was conducted according to preoperative nutritional requirements
Behavioral: Dietary mission
Dietary education was conducted according to preoperative nutritional requirements




Primary Outcome Measures :
  1. Incidence of complications at 30 days after surgery [ Time Frame: 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 :
  1. Postoperative hospital stay [ Time Frame: up to 90 days after surgery ]
    from the date of the operation to the date of discharge



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218253


Contacts
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Contact: Chunlei Li, Doctor 18622370261 lcltjmu507@163.com
Contact: Kun Wang, Doctor 23340123 ext 1155 lcltjmu507@163.com

Locations
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China
Tianjin Medical University cancer Instituteand Hospital Recruiting
Tianjin, China
Contact: Kun Wang    23340123 ext 1155    lcltjmu507@163.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Study Chair: Kun Wang, Doctor Tianjin Medical University cancer Instituteand Hospital

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT04218253    
Other Study ID Numbers: 20191226
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Nutrition Therapy
Hepatectomy
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Nutrients
Growth Substances
Physiological Effects of Drugs