UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of perioperative nutritional intervention on liver regeneration after hepatectomy.
Title of the study (Brief title)	Effects of perioperative nutritional intervention on liver regeneration after hepatectomy.
Region	Japan

Condition
Condition	hepatocellular carcinoma cases require hepatectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of perioperative nutritional intervention for hepatocellular carcinoma with hypoalbuminemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	postoperative improvement of liver function
Key secondary outcomes	postoperative course liver regeneration rate

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	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Branched-chain amino acid granules(BCAA, Livact) is orally administered three times a day for 2 weeks prior to hepatectomy and 1 month after hepatectomy(hypoalbuminemia group).
Interventions/Control_2	No administration of BCAA (hypoalbuminemia group).
Interventions/Control_3	No administration of BCAA (normal albumin level group).
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)hepatocellular carcinoma(including combined hepatocellular and cholangiocarcinoma) by preoperative imaging examination 2)planned hepatectomy 3)ECOG Performance Status 0 to 2 4)appropriate liver function for hepatectomy according to the results of the Child-Pugh classification and the ICG-R15 test (within 30 days before the registration) 5)written informed consent
Key exclusion criteria	1)severe diabetes, or suspected abnormal sugar metabolism because of high dosage of steroids 2)abnormal amino acid metabolism 3)history of hypersensitivity against Livact 4)pregnant or willing to get pregnant 5)patien's offer discontinuation of the study 6)doctor's decision not to be registered to the study
Target sample size	30

Research contact person
Name of lead principal investigator	Osamu Itano
Organization	Department of Surgery, Keio University School of Medicine
Division name	Department of Surgery
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	contact@keio-hpbts.jp

Public contact
Name of contact person	Hiroshi Yagi
Organization	Department of surgery, Keio University, school of medicine
Division name	Department of Surgery
Address	Shinanomachi 35, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	contact@keio-hpbts.jp

Sponsor
Institute	Keio University 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)

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	慶応義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 04 Month 03 Day
Anticipated trial start date	2014 Year 04 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 12 Day
Last modified on	2017 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017147