UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028296 |
|---|---|
| Receipt number | R000032393 |
| Scientific Title | Evaluation of liver graft based on liver stiffness measurement of ARFI in patients with liver transplantaion |
| Date of disclosure of the study information | 2017/07/20 |
| Last modified on | 2021/07/28 10:22:09 |
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Basic information
Public title
Evaluation of liver graft based on liver stiffness measurement of ARFI in patients with liver transplantaion
Acronym
Evaluation of liver graft based on liver stiffness measurement of ARFI in patients with liver transplantaion
Scientific Title
Evaluation of liver graft based on liver stiffness measurement of ARFI in patients with liver transplantaion
Scientific Title:Acronym
Evaluation of liver graft based on liver stiffness measurement of ARFI in patients with liver transplantaion
Region
| Japan |
Condition
Condition
liver transplantaion
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate usefulness of liver stiffness measurement by acoustic radiation force impulse (ARFI) imaging for the evaluation of graft fibrosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between liver stiffness measured by acoustic radiation force impulse imaging and liver fibrosis after liver transplantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
ultrasound examination
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients after liver transplantation who undergo liver biopsy in our department and give written informed consent
Key exclusion criteria
Pediatric case who can not hold his / her breath.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kojiro |
| Middle name | |
| Last name | Taura |
Organization
Kyoto University Graduate School of Medicine
Division name
Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL
+81-75-751-3242
ktaura@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Taura |
Organization
Kyoto University Graduate School of Medicine
Division name
Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL
+81-75-751-3242
Homepage URL
ktaura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate 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
Kyoto University Graduate School of Medicine
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
Tel
+81-75-753-4680
ethcom@kuhp.kyoto-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
京都大学医学部付属病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 20 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 20 | Day |
Last modified on
| 2021 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032393
