The investigation for the improvement of nutrition using a branched-chain amino acid (BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma
Phase 3
- Conditions
- iver cirrhosis associated with hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000001255
- Lead Sponsor
- Department of Gastroenterology and Hepatology, Yamaguchi Univercity Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1. Extrahepatic metastasis 2. History of anaphylactic reaction for amino acid nutrient 3. Severe renal dysfunction 4. Congenital amino-acid metabolism abnormality 5. Milk allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method occurence of the following events: ascites, peripheral edema, bleeding of gastrointerstinal tract, hepatic encephalopathy, others
- Secondary Outcome Measures
Name Time Method SF-36 nutrition status using an indirect calorimeter(RQ) reserved liver function(Alb) BTR Change of blood cell count(WBC, RBC, lymphocyte, Plt)