UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057753 |
|---|---|
| Receipt number | R000066000 |
| Scientific Title | External validity of 13 previously reported formulas for calculating standard liver volume, with particular emphasis on age-related external validity |
| Date of disclosure of the study information | 2025/05/02 |
| Last modified on | 2025/05/01 17:04:27 |
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Basic information
Public title
Re-evaluation of the formulae for calculating standard liver volume, particularly in relation to age
Acronym
Re-evaluation of standard liver volume
Scientific Title
External validity of 13 previously reported formulas for calculating standard liver volume, with particular emphasis on age-related external validity
Scientific Title:Acronym
Evaluation of the external validity of the formula for calculating standard liver volume
Region
| Japan |
Condition
Condition
non-hepatic disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Living donor liver transplantation involves implanting a graft smaller than the recipient's original liver. While the liver has strong regenerative capacity and the graft is expected to grow over time, a smaller graft may initially fail to meet the body's metabolic demands. Determining the minimum acceptable graft size is therefore crucial and depends on comparing graft volume with the recipient's expected liver volume.
However, most transplant candidates have end-stage liver disease, and their livers are often pathologically enlarged or atrophied. As such, it is inappropriate to use their liver size as a reference. Instead, a physiologic liver volume should be estimated based on body size.
Urata et al. (1995) proposed a widely used standard liver volume (SLV) formula based on body surface area in healthy individuals. Since then, numerous SLV formulae have been introduced, but no consensus exists regarding the optimal one.
Liver volume changes throughout life, relatively large in infancy and declining with age after adulthood. Many SLV formulae overlook this and are extrapolated beyond their original age ranges without proper validation. This study addresses these limitations and examines how age affects the relationship between body size and standard liver volume.
Basic objectives2
Others
Basic objectives -Others
To perform an external evaluation of the validity of the formula within the range of the original data that resulted in various calculations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of estimated liver volume calculated using the formula
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
| 1 | months-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases in which the liver was imaged by contrast-enhanced CT in non-liver disease cases
Key exclusion criteria
Cases with liver disease, cases with a history of liver resection, cases without contrast-enhanced CT
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Saiura |
Organization
Juntendo University Graduate School of Medicine
Division name
Division of Hepatibiliary-pancreatic Surgery
Zip code
113-8431
Address
Juntendo University Hospital, Hongo, 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3811-3111
hrimamur@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Imamura |
Organization
Juntendo University Graduate School of Medicine
Division name
Division of Hepatibiliary-pancreatic Surgery
Zip code
113-8421
Address
Juntendo University Hospital, Hongo, 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL
+819042256342
Homepage URL
hrimamur@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo,Japan
Tel
+81-3-5802-1584
hongo-rinri@juntendo.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
| 2025 | Year | 05 | Month | 02 | 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
1000
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study of non-liver disease cases that underwent contrast-enhanced CT examination of the liver at Juntendo University Hospital.
Management information
Registered date
| 2025 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066000
