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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005200
Receipt No. R000006176
Scientific Title Effects of branched-chain amino acid on the suppression of recurrence after hepatectomy for patients of liver cirrhosis with hepatocellular carcinoma
Date of disclosure of the study information 2011/07/01
Last modified on 2012/03/09

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Basic information
Public title Effects of branched-chain amino acid on the suppression of recurrence after hepatectomy for patients of liver cirrhosis with hepatocellular carcinoma
Acronym Effects of BCAA on the suppression of recurrence after hepatectomy for patients of liver cirrhosis with hepatocellular carcinoma
Scientific Title Effects of branched-chain amino acid on the suppression of recurrence after hepatectomy for patients of liver cirrhosis with hepatocellular carcinoma
Scientific Title:Acronym Effects of BCAA on the suppression of recurrence after hepatectomy for patients of liver cirrhosis with hepatocellular carcinoma
Region
Japan

Condition
Condition liver cirrhosis with hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation for the effects of branched-chain amino acid on the suppression of recurrence after hepatectomy for the patients of hepatocellular carcinoma with liver cirrhosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes disease free interval
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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 take LIVACT orally 3 times per day for 3 years after hepatctomy
Interventions/Control_2 persons who did not intake LIVACT after hepatectomy performed from January 2004 to December 2007.(control)
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

Not applicable
Gender Male and Female
Key inclusion criteria persons who can intake meal enough
hypoalbuminemia (4.0g/dL or lower)
Child-Pugh A or B
Key exclusion criteria hepatic encephalopathy
serum albumin<2.5g/dL
Total bilirubin 3mg/dL or higher
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hatano Etsuro
Organization Kyoto university hospital
Division name Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address 54 Syogoinkawaharacho Sakyo-ku Kyoto-shi Kyoto-fu
TEL 075-751-3608
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto university hospital
Division name Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address 54 Syogoinkawaharacho Sakyo-ku Kyoto-shi Kyoto-fu
TEL 075-751-3608
Homepage URL
Email shiryou@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university hospital, Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Institute
Department

Funding Source
Organization Kyoto university hospital, Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sapporo medical university hospital, First department of surgery
Yamaguchi university hospital, Department of digestive surgery and surgical oncology
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

Other administrative information
Date of disclosure of the study information
2011 Year 07 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
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2011 Year 07 Month 01 Day
Date analysis concluded
2011 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 06 Day
Last modified on
2012 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006176

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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