UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017707
Receipt number R000020516
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
Date of disclosure of the study information 2015/06/01
Last modified on 2019/11/29 09:56:14

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020516


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name