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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007172
Receipt No. 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

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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
Last 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
Email ktaura@kuhp.kyoto-u.ac.jp

Public contact
1st 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
Email ktaura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008451

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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