UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001361 |
|---|---|
| Receipt number | R000001594 |
| Scientific Title | Effects of oral branched chain amino acids (BCAA) supplementation in liver function and QOL after liver resection for hepatocellular carcinoma with liver cirrhosis |
| Date of disclosure of the study information | 2008/09/15 |
| Last modified on | 2008/09/09 11:57:32 |
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Basic information
Public title
Effects of oral branched chain amino acids (BCAA) supplementation in liver function and QOL after liver resection for hepatocellular carcinoma with liver cirrhosis
Acronym
Effects of oral branched chain amino acids (BCAA) supplementation after liver resection for hepatocellular carcinoma
Scientific Title
Effects of oral branched chain amino acids (BCAA) supplementation in liver function and QOL after liver resection for hepatocellular carcinoma with liver cirrhosis
Scientific Title:Acronym
Effects of oral branched chain amino acids (BCAA) supplementation after liver resection for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma with liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate if oral BCAA supplementation is effective after liver resection for hepatocellular carcinoma with liver cirrhosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver function and QOL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral branched chain amino acids from 5 day to 28 day after liver resecton
Interventions/Control_2
diet for liver cirrhosis
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients planed liver resection for hepatocellular carcinoma with liver cirrhosis
2)no gender
3)Written informed consent for patients or
Key exclusion criteria
1)over 76 years old
2)ICG-R15: 35-40%
3)asites ineffective with a diuretic
4)jaundice
5)liver damage: grade C
6)an allergy to milk
7)renal damage: over Cr 2.0mg/dl
8)primary aminoaciduria
9)pregnant or nursing woman
10)unsutable patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Mori |
Organization
Graduate School of Medicine, OSAKA University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka E2, Suita, 565-0871, Osaka
TEL
06-6879-3258
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagano |
Organization
Graduate School of Medicine, OSAKA University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka E2, Suita, 565-0871, Osaka
TEL
06-6879-3251
Homepage URL
Sponsor or person
Institute
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2006 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 09 | Day |
Last modified on
| 2008 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001594
