UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004244 |
|---|---|
| Receipt number | R000005100 |
| Scientific Title | A randomized controlled trial for the comparison of the benefit of preoperative supplementation of a branched chain amino acid (BCAA) granules for patients undergoing liver resection for hepatocellular carcinoma. |
| Date of disclosure of the study information | 2010/09/24 |
| Last modified on | 2015/03/13 09:46:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomized controlled trial for the comparison of the benefit of preoperative supplementation of a branched chain amino acid (BCAA) granules for patients undergoing liver resection for hepatocellular carcinoma.
Acronym
A randomized controlled trial for the comparison of the benefit of preoperative supplementation of a branched chain amino acid (BCAA) granules for patients undergoing liver resection for hepatocellular carcinoma.
Scientific Title
A randomized controlled trial for the comparison of the benefit of preoperative supplementation of a branched chain amino acid (BCAA) granules for patients undergoing liver resection for hepatocellular carcinoma.
Scientific Title:Acronym
A randomized controlled trial for the comparison of the benefit of preoperative supplementation of a branched chain amino acid (BCAA) granules for patients undergoing liver resection for hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the benefit of preoperative supplementation of a branched chain amino acid (BCAA) granules for patients undergoing liver resection for hepatocellular carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of postoperative ascites
Key secondary outcomes
The morbidity rate and hospital stay after hepatectomy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preoperative BCAA supplementation group
The patients of this group will received BCAA supplementation 21 days before liver resection.
Interventions/Control_2
Control group
The patients of this group will not received BCAA supplementation 21 before liver resection.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who will undergo hepatectomy for hepatocellular carcinoma. The operation is not emergency.
Key exclusion criteria
The patient who undergo hepatectomy with biliary reconstraction.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuniya Tanaka |
Organization
Yokohama city university graduate school of medicine
Division name
Department of gastroenterological surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2650
U17-92TS@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuniya Tanaka |
Organization
Yokohama city university graduate school of medicine
Division name
Department of gastroenterological surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2650
Homepage URL
U17-92TS@med.teikyo-u.ac.jp
Sponsor or person
Institute
Yokohama city university graduate school of medicine
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 24 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 21 | Day |
Last modified on
| 2015 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005100
