UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005200 |
|---|---|
| Receipt number | 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 16:19:59 |
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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
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
shiryou@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university hospital, Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006176
