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Recruitment status Terminated
Unique ID issued by UMIN UMIN000003085
Receipt No. 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

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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
Email

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
Email morimoto@urahp.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center Gastroenterological Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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