UMIN-CTR Clinical Trial

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

Liver cirrhosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Annual changes in muscle mass volume

Key secondary outcomes

Overall survival
Time to liver disease-related event

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hyogo College of Medicine

Institute

Department

Personal name

Organization

EA Pharma Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

None

Name of secondary funder(s)

None

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

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)

Date of disclosure of the study information

2016

Year

07

Month

20

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

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 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.

Registered date

2016

Year

07

Month

20

Day

Last modified on

2019

Year

02

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026793