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Completed

NCT Number: NCT00945568

Preoperative Oral Supplementation With Branched-Chain Amino Acids (BCAA) Improves Postoperative Quality of Life

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 quality of life (QOL) in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for hepatocellular carcinoma (HCC) with chronic liver disease.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kochi Medical School, Nankoku, Kochi, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aminoleban EN

Drug

benefits of this drug for patients who undergoing liver resection for HCC

Other names: AEN

Primary outcomes

  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.

    Time frame: 3-6 months

Secondary outcomes

  1. To investigate the safety, rationality and 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.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Kochi University

Other

Registry information

Official study title

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

Acronym: KMS

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jul 24, 2009
Registry last updated
Jul 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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