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
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
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
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
