UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041121 |
|---|---|
| Receipt number | 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 | 2021/07/20 20:12:42 |
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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
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
kiruha555@yahoo.co.jp
Sponsor or person
Institute
shonan kamakura general hospital
Institute
Department
Personal name
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
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
Open public recruiting
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
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046960
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