change in Muscle volume In patients with LivEr cirrhosis: prospective cohort Study

change in Muscle volume In patients with LivEr cirrhosis: prospective cohort Study - MILE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023256

Enrollment

300

Registered

2016-07-20

Start date

2015-12-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Annual changes in muscle mass volume	—

Secondary

Measure	Time frame
Overall survival Time to liver disease-related event	—

Countries

Japan

Contacts

Public ContactHiroki Nishikawa

Hyogo College of Medicine Division of Hepatobiliary and Pancreatic Disease

nishikawa_6392@yahoo.co.jp0798(45)6111

Outcome results