UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004244
Receipt No. 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

* 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
Email 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
Email U17-92TS@med.teikyo-u.ac.jp

Sponsor
Institute Yokohama city university graduate school of medicine
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005100

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.