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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041121
Receipt No. R000046960
Scientific Title Comparison of Segmental Body Composition estimated by BIA and CT in cirrhotic patients with ascites
Date of disclosure of the study information 2020/07/17
Last modified on 2020/07/15

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Basic information
Public title Comparison of Segmental Body Composition estimated by BIA and CT in cirrhotic patients with ascites
Acronym Comparison of Segmental Body Composition estimated by BIA and CT
Scientific Title Comparison of Segmental Body Composition estimated by BIA and CT in cirrhotic patients with ascites
Scientific Title:Acronym Comparison of Segmental Body Composition estimated by BIA and CT
Region
Japan

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

Objectives
Narrative objectives1 To assess the measurements of muscle mass by using CT or BIA in patient with hepatic ascites and/or edema.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess the correlation between segmental body composition from BIA and CT in cirrhotic patients with ascites and/or edema.
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 Liver cirrhosis
2 Age > 20 years, male and female
Key exclusion criteria 1 Malignancy
2 Severe renal dysfunction (eGFR<30)
3 Severe cardiac disease
4 Severe pulmonary disease
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name haruki
Last name Kako
Organization shonan kamakura general hospital
Division name department of gastroenterology
Zip code 247-8533
Address 1370-1 okamoto,kamakura, kanagawa, japa
TEL 0467-46-1717
Email kiruha555@yahoo.co.jp

Public contact
Name of contact person
1st name uojima
Middle name haruki
Last name haruki
Organization shonan kamakura general hospital
Division name department of gastroenterology
Zip code 247-8533
Address 1370-1 Okamoto, Kamakura
TEL 0467-46-1717
Homepage URL
Email kiruha555@yahoo.co.jp

Sponsor
Institute shonan kamakura general hospital
Institute
Department

Funding Source
Organization none
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 Shonan kamakura general hospital Clinical Research Center
Address 1370-1 Okamoto, Kamakura
Tel 0467-47-1919
Email k_asou@shonankamakura.or.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
2020 Year 07 Month 17 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 Preinitiation
Date of protocol fixation
2019 Year 07 Month 09 Day
Date of IRB
2018 Year 12 Month 09 Day
Anticipated trial start date
2020 Year 07 Month 16 Day
Last follow-up date
2021 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 07 Month 15 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046960

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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