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Preoperative Oral Supplementation With Carbohydrate and Branched-chain Amino Acid-enriched Nutrient Improves Postoperative Quality of Life in Patients Undergoing a Hepatectomy


N/A
N/A
N/A
Not Enrolling
Both
Hepatocellular Carcinoma, Chronic Liver Disease

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Trial Information

Preoperative Oral Supplementation With Carbohydrate and Branched-chain Amino Acid-enriched Nutrient Improves Postoperative Quality of Life in Patients Undergoing a Hepatectomy


Patients with cirrhosis of the liver complicated with HCC are often in a state of protein
energy malnutrition. A limited number of studies have indicated an important role for
nutritional support in the surgical management of patients who have undergone hepatic
resection for HCC. In a preliminary study, we reported the clinical efficacy of
supplementation with branched-chain amino acids in a small number of patients with liver
cirrhosis who underwent hepatic surgery for HCC. The aims of this study are (1) to study the
benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of
clinical parameter, including laboratory data, the duration of hospitalization after the
surgery, and (2) To investigate the postoperative QOL in receiving peri-operatively
branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic
management for HCC with chronic liver disease.


Inclusion Criteria:



- Patients who underwent elective liver resection for the treatment of hepatocellular
carcinoma or adenocarcinoma with chronic liver diseases.

Exclusion Criteria:

- Body weight loss greater than 10 per cent during the 6 months prior to surgery,

- The presence of distant metastases, or seriously impaired function of vital organs
due to respiratory, renal or heart disease.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery.

Outcome Time Frame:

3-6 months

Safety Issue:

Yes

Principal Investigator

Kazuhiro Hanazaki, Prof

Investigator Role:

Study Director

Investigator Affiliation:

Kochi University

Authority:

United States: Food and Drug Administration

Study ID:

AEN-0901

NCT ID:

NCT00945568

Start Date:

May 2007

Completion Date:

June 2009

Related Keywords:

  • Hepatocellular Carcinoma
  • Chronic Liver Disease
  • QOL
  • liver
  • Carcinoma
  • Liver Diseases
  • Carcinoma, Hepatocellular

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