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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023256
Receipt No. R000026793
Scientific Title change in Muscle volume In patients with LivEr cirrhosis: prospective cohort Study
Date of disclosure of the study information 2016/07/20
Last modified on 2019/02/18

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Basic information
Public title change in Muscle volume In patients with LivEr cirrhosis: prospective cohort Study
Acronym MILE Study
Scientific Title change in Muscle volume In patients with LivEr cirrhosis: prospective cohort Study
Scientific Title:Acronym 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
1st name
Middle name
Last name Shuhei Nishiguchi
Organization Hyogo College of Medicine
Division name Division of Hepatobiliary and Pancreatic Disease
Zip code
Address 1-1 Mukogawa, Nishinomiya,Hyogo
TEL 0798(45)6111
Email cc15002e@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Nishikawa
Organization Hyogo College of Medicine
Division name Division of Hepatobiliary and Pancreatic Disease
Zip code
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

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 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

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 No longer recruiting
Date of protocol fixation
2015 Year 12 Month 08 Day
Date of IRB
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

Other
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

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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