UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007172 |
|---|---|
| Receipt number | R000008451 |
| Scientific Title | Establishment of a new criteria for secure liver resection by liver stiffness measurement with acoustic radiation force impulse imaging |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2018/02/15 02:09:26 |
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Basic information
Public title
Establishment of a new criteria for secure liver resection by liver stiffness measurement with acoustic radiation force impulse imaging
Acronym
Usefulness of acoustic radiation force impulse imaging for secure liver resection
Scientific Title
Establishment of a new criteria for secure liver resection by liver stiffness measurement with acoustic radiation force impulse imaging
Scientific Title:Acronym
Usefulness of acoustic radiation force impulse imaging for secure liver resection
Region
| Japan |
Condition
Condition
primary liver cancer
metastatic liver cancer
benign liver tumor
living liver donor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate usefulness of acoustic radiation force impulse imaging for the prediction of postoperative liver failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between liver stiffness measured by acoustic radiation force impulse imaging and postoperative liver failure
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 who undergo liver resection in our department and give written informed consent
Key exclusion criteria
The patients who undergo liver resection with biliary resection and reconstruction
The patients who underwent preoperative portal vein embolization
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taura Kojiro |
Organization
Kyoto University Graduate School of Medicine
Division name
Surgery
Zip code
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 | |
| Middle name | |
| Last name | Taura Kojiro |
Organization
Kyoto University Graduate School of Medicine
Division name
Surgery
Zip code
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
Self funding
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
Address
Tel
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
| 2012 | Year | 02 | Month | 01 | 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
Results
Liver stiffness measurement by ARFI is useful for predicting posthepatectomy liver failure.
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
Main results already published
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008451
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
