UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of the criterion of sarcopenia in chronic liver disease
Acronym	Sarcopenia in chronic liver disease
Scientific Title	Efficacy of the criterion of sarcopenia in chronic liver disease
Scientific Title:Acronym	Sarcopenia in chronic liver disease
Region	Japan

Condition
Condition	Chronic liver disesase
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of the criterion of the sarcopenia in chronic liver disease
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the survival span of patient with sarcopenia and non-sarcopenia
Key secondary outcomes

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) chronic liver disease 2) Cases obtained written informed consent
Key exclusion criteria	1) Cases regarded by doctors as inappropriate for the enrollment for some reasons
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Uojima Middle name Last name Haruki
Organization	Kitasato University school of medicine
Division name	Department of Gastroenterology
Zip code	252-0375
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Email	kiruha555@yahoo.co.jp

Public contact
Name of contact person	1st name Haruki Middle name Last name Uojima
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Zip code	252-0375
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Homepage URL
Email	kiruha555@yahoo.co.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Kitasato University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato institute hospital research ethics committee
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
Tel	+81-42-778-8111
Email	mailtorinri@med.kitasato-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	300
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	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Date of IRB	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2021 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The new JSH criteria for sarcopenia are accurate predictors of poor prognosis in patients with liver cirrhosis.

Management information
Registered date	2016 Year 09 Month 06 Day
Last modified on	2021 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027510