UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003085 |
|---|---|
| Receipt number | R000003747 |
| Scientific Title | Effects of branched-chain amino acids support in patients undergoing radiofrequency ablation for hepatocellular carcinoma: a randomized controlled study |
| Date of disclosure of the study information | 2010/02/01 |
| Last modified on | 2013/08/20 09:34:19 |
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Basic information
Public title
Effects of branched-chain amino acids support in patients undergoing radiofrequency ablation for hepatocellular carcinoma: a randomized controlled study
Acronym
Effects of branched-chain amino acids support in patients undergoing radiofrequency ablation for hepatocellular carcinoma: a randomized controlled study
Scientific Title
Effects of branched-chain amino acids support in patients undergoing radiofrequency ablation for hepatocellular carcinoma: a randomized controlled study
Scientific Title:Acronym
Effects of branched-chain amino acids support in patients undergoing radiofrequency ablation for hepatocellular carcinoma: a randomized controlled study
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
target population:patients with liver cirhosis and early-stagehepatocellular carcinoma
Aim:Evaluation of the benefit of oral branched chain amino acids in patients with hepatocellularcarcinoma undergoing local ablation treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Short- to mid-term effects of liver function and nutrition status during the post ablative period.
Key secondary outcomes
Time to tumor progression
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients in the BCAA group received BCAA orally administration before tumor ablation therapy until 1 month after the therapy.
Interventions/Control_2
The patients in the diet group received diet therapy with defined daily food intake.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Early-stage hepatocellular carcinoma(BCLC staging)
2)Compensated liver cirrhosis
3) Equal to or more than 20 years old.
Key exclusion criteria
Exclusion criteria are the presence of any one of the following: serum albumin <2.5mg dL, serum total bilirubin level <3mg/dL, hepatic encephalopathy of or above grade II, history of albumin infusion or receiving BCAA granules in the preceding 3 months, and bleeding varices.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Morimoto |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Morimoto |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
morimoto@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center Gastroenterological Center
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
横浜市立大学附属市民総合医療センター （神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | 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
| 2010 | Year | 01 | Month | 25 | Day |
Last modified on
| 2013 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003747
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
