UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The University of Tokyo

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

10

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

10

Month

19

Day

Last modified on

2015

Year

05

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009838