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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014732
Receipt No. R000017124
Scientific Title Posthepatectomy portal vein pressure and postoperative complications after major liver resection
Date of disclosure of the study information 2014/08/01
Last modified on 2017/07/03

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Basic information
Public title Posthepatectomy portal vein pressure and postoperative complications after major liver resection
Acronym Posthepatectomy portal vein pressure and postoperative complications after major liver resection
Scientific Title Posthepatectomy portal vein pressure and postoperative complications after major liver resection
Scientific Title:Acronym Posthepatectomy portal vein pressure and postoperative complications after major liver resection
Region
Japan

Condition
Condition Liver cancer
Bile duct cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate whether how much portal vein pressure induce posthepatectomy liver failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes prehepatectomy portal vein pressure, posthepatectomy poretal vein pressure
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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 We measure prehepatectomy and posthepatectomy portal vein pressure.
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 major hepatectomy
Key exclusion criteria cirrhotic liver
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Ishizaki
Organization Juntendo University School
Division name Hepatobiliary-Pancreatic Surgery
Zip code
Address 2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL 03-3813-3111
Email ishizaki@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Matsudaira
Organization Juntendo University School
Division name Hepatobiliary-Pancreatic Surgery
Zip code
Address 2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL 03-3813-3111
Homepage URL
Email smatuda@juntendo.ac.jp

Sponsor
Institute Department of Hepatobiliary-Pancreatic Surgery,Juntendo University School of Medicen
Institute
Department

Funding Source
Organization Department of Hepatobiliary-Pancreatic Surgery,Juntendo University School of Medicen
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
2014 Year 08 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
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 Terminated
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 31 Day
Last modified on
2017 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017124

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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