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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009154
Receipt No. R000009838
Scientific Title The Effect of Branched Chain Amino Acid to the Perioperative Nutritional Status: In Patients with Cirrhosis Undergoing Liver Resection and Patients Awaiting Liver Transplantation.
Date of disclosure of the study information 2012/10/22
Last modified on 2015/05/04

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Basic information
Public title The Effect of Branched Chain Amino Acid to the Perioperative Nutritional Status: In Patients with Cirrhosis Undergoing Liver Resection and Patients Awaiting Liver Transplantation.
Acronym The effect of the neutritional support in perioperative care of hepatic resection and Liver transplantation.
Scientific Title The Effect of Branched Chain Amino Acid to the Perioperative Nutritional Status: In Patients with Cirrhosis Undergoing Liver Resection and Patients Awaiting Liver Transplantation.
Scientific Title:Acronym The effect of the neutritional support in perioperative care of hepatic resection and Liver transplantation.
Region
Japan

Condition
Condition The patient with cirrhosis undergoing liver resection.(hepatocellular carcinoma, bile duct cancer, metastasis of colorectal cancer, and other malignant tumors)
The patient awaiting for liver transolantation.(Liver cirrhosis, Hepatocellular carcinoma, Fulminant hepatic failure, Primary billiary cirrosis, Primary screlosing cholangitis,
Autoimune hepatitis, and other metabolic liver diseases.)
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To invastigate the improvement of nutritional status and reduction of postoerative infectious complications in hepatic resection or liver transplantation by taking branced chain amino acid as a late-evening snack.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body cell mass
Key secondary outcomes Infectious complications, Other complications, Neutritional indexes, Length of hospital stay, Recurrence-free survival time, Overall survival time.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients assigned for intervention group take Branched-chain amino acid formula as late-evening snack for 2 weeks preoperatively in hepatic resction,and for 4 weeks in liver transplantation,respectively.
Administration of BCAA formula would be maintained for 12 weeks postoperatively in both procedure.
Interventions/Control_2 Patients in the control group are observed without administration of BCAA formula.
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 Patients assigned to this study must be compatible with all criteria listed below.

1)Patients awaiting liver transplantation or patients with cirrhosis( ICG R15 > 15%) undergoing hepatic resection.

2)Patients undergoing hepatic resection must be over the age 20,and under the age of 80.
Patients awaiting liver transplantation must be over the age of 20,
and under the age of 65.

3)Sufficient understanding of the study and voluntary consent for the study in writting.
Key exclusion criteria 1) Patients who have already taken Branched -chain amino acid formula before.
2) Patients who have a past history of milk allergy.
3) Patients who have or be suspected of having glycometabolism dysfunction due to severe diabetes mellitus or bolus administration of steroidal drugs.
4)Patients who are in the first trimester of pregnancy or wish to become pregnant.
5)Patients with amino-acid metabolism dysfunction.
6) Patients with fulminant hepatitis.
7) Patients who are considered medically inappropriate for registration.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kokudo Norihiro
Organization The University of Tokyo
Division name Depertment of Hepato-Billiary-Pancreatic Surgery, Guraduate School of Medicine
Zip code
Address 7-3-1 Hongo Bunkyoku Tokyo
TEL 03-3815-5411
Email rnagata-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nagata Rihito
Organization The University of Tokyo
Division name epertment of Hepato-Billiary-Pancreatic Surgery, Guraduate School of Medicine
Zip code
Address 7-3-1 Hongo Bunkyoku Tokyo
TEL 03-3815-5411
Homepage URL
Email rnagata-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
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

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 22 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 Enrolling by invitation
Date of protocol fixation
2012 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 19 Day
Last modified on
2015 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009838

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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