UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	change in Muscle volume In patients with LivEr cirrhosis: prospective cohort Study
Title of the study (Brief title)	MILE Study
Region	Japan

Condition
Condition	Liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate changes in muscle volume in patients with liver cirrhosis as assessed by abdominal CT scan
Basic objectives2	Others
Basic objectives -Others	Changes of muscle mass volume
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Annual changes in muscle mass volume
Key secondary outcomes	Overall survival Time to liver disease-related event

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Liver cirrhosis patients with hypoalbuminemia (serum albumin level <3.5g/dl) at the time of registration or past history for hypoalbuminemia 2.Patients with decompensated liver cirrhosis (with ascites, edema and/or hepatic encephalopathy at present or past history of ascites, edema and/or hepatic encephalopathy) 3.Patients aged 20 years or more
Key exclusion criteria	1.Patients being treated with intravenous albumin preparation 2.Patients being treated with fresh frozen plasma formulation 3.Patients with stage II or more advanced HCC 4.Patients with uncontrollable HCC 5.Patients with total bilirubin >3.0 mg/dl 6.Patients with hepatic encephalopathy (hepatic coma: grade III or more) 7.Patients with congenital branched-chain amino acid related metabolic disorders 8.Patients with malignancies other than HCC 9.Patients ineligible for study as determined by research investigator or research doctor
Target sample size	300

Research contact person
Name of lead principal investigator	Shuhei Nishiguchi
Organization	Hyogo College of Medicine
Division name	Division of Hepatobiliary and Pancreatic Disease
Address	1-1 Mukogawa, Nishinomiya,Hyogo
TEL	0798(45)6111
Email	cc15002e@hyo-med.ac.jp

Public contact
Name of contact person	Hiroki Nishikawa
Organization	Hyogo College of Medicine
Division name	Division of Hepatobiliary and Pancreatic Disease
Address	1-1 Mukogawa, Nishinomiya,Hyogo
TEL	0798(45)6111
Homepage URL
Email	nishikawa_6392@yahoo.co.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	EA Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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

兵庫医科大学病院（兵庫）Hyogo College of Medicine(Hyogo) 岐阜大学医学部附属病院（岐阜）Gifu University Hospital（Gifu) 山口大学医学部附属病院（山口）Yamaguchi University Hospital(Yamaguchi) 岩手医科大学（岩手）Iwate Medical University(Iwate) 久留米大学（福岡）Kurume University(Fukuoka) 三重大学（三重）　Mie University(Mie) 大阪国際がんセンター（大阪）Osaka International Cancer Institute(Osaka) 杏林大学（東京）Kyorin Univrsity(Tokyo) 愛媛大学医学部付属病院（愛媛）Ehime University Hospital(Ehime) 東海大学（神奈川）　Tokai University(Kanagawa) 獨協医科大学越谷病院（埼玉）Dokkyo Medical University Hospital(Saitama) 関西医科大学（大阪）KANSAI MEDICAL UNIVERSITY(Osaka) 国際医療福祉大学（栃木）International University of health and welfare(Tochigi) JCHO大阪病院（大阪）Osaka　Hospital(Osaka) 東海大学大磯病院（神奈川）Tokai University Oiso Hospital(Kanagawa) 九州医療センター（福岡）National Kyushu Medical Center(Fukuoka) 愛媛県立中央病院（愛媛）Ehime Prefectural Central Hospital(Ehime) 広島大学病院（広島）Hiroshima University Hospital(Hiroshima) 佐賀大学医学部附属病院（佐賀）Saga University Hospital(Saga) 奈良県立医科大学附属病院（奈良）Nara Medical University Hospital(Nara)

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 12 Month 08 Day
Anticipated trial start date	2015 Year 12 Month 08 Day
Last follow-up date	2020 Year 12 Month 31 Day
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	In this prospective, observational study, we include patients with liver cirrhosis (with hypoalbuminemia) between December 18,2015 and December 31,2018, all of whom met the selection criteria.

Management information
Registered date	2016 Year 07 Month 20 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026793