UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of a new criteria for secure liver resection by liver stiffness measurement with acoustic radiation force impulse imaging
Title of the study (Brief title)	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	Taura Kojiro
Organization	Kyoto University Graduate School of Medicine
Division name	Surgery
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL	+81-75-751-3242
Email	ktaura@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Taura Kojiro
Organization	Kyoto University Graduate School of Medicine
Division name	Surgery
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Liver stiffness measurement by ARFI is useful for predicting posthepatectomy liver failure.
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/icdr_e/ctr_view.cgi?recptno=R000008451