UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of hepatic flow volume, elasticity and liver function in the remnant liver after hepatectomy with sacrifice of major hepatic veins by using intraoperative ultrasonography
Acronym	Evaluation of hepatic flow volume, elasticity and liver function in the remnant liver after hepatectomy with sacrifice of major hepatic veins by using intraoperative ultrasonography
Scientific Title	Evaluation of hepatic flow volume, elasticity and liver function in the remnant liver after hepatectomy with sacrifice of major hepatic veins by using intraoperative ultrasonography
Scientific Title:Acronym	Evaluation of hepatic flow volume, elasticity and liver function in the remnant liver after hepatectomy with sacrifice of major hepatic veins by using intraoperative ultrasonography
Region	Japan

Condition
Condition	veno-occlusive regions of liver after resection or endovascular treatment of major hepatic veins which comprise right hepatic vein, middle hepatic vein, left hepatic vein, middle right hepatic vein, or inferior right hepatic vein
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	quantitative evaluation of hepatic flow volume, elasticity and liver function in the remnant liver including veno-occlusive regions
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The amount of hepatic flow volume and elasticity value of veno-occlusive and non-veno-occlusive regions in the remnant liver
Key secondary outcomes	Comparison of regeneration rate between veno-occusive regions and non-veno-occlusive regions

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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)patients undergoing liver resection with excision of major hepatic veins or endovascular treatment which develops veno-occlusive regions 2)Portal veins flowing future veno-occlusive regions can be identified by ultrasonography for patients who met the criteria 1.
Key exclusion criteria	1)patients who can not undergo contrast enhanced computed tomography due to allergy and renal function impairment (eGFR < 30) 2)pregnant women or women of childbearing potential 3)lactating women
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Norihiro Middle name Last name Kokudo
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	KOKUDO-2SU@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Harufumi Middle name Last name Maki
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	MAKIH-SUR@h.u-tokyo.ac.jp

Sponsor
Institute	Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	None
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	Graduate School of Medicine, The University of Tokyo
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel	03-3815-5411
Email	ethics@m.u-tokyo.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	東京大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 01 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	5
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	2015 Year 05 Month 27 Day
Date of IRB	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational study of quantitative estimation of liver function in the remnant liver including veno-occlusive regions

Management information
Registered date	2015 Year 05 Month 27 Day
Last modified on	2019 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020516