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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003317
Receipt No. R000004028
Scientific Title A randomized controlled trial for the comparison of the bleeding during hepatectomy with and without clamping the inferior vena cava below the liver.
Date of disclosure of the study information 2010/03/15
Last modified on 2014/03/11

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Basic information
Public title A randomized controlled trial for the comparison of the bleeding during hepatectomy with and without clamping the inferior vena cava below the liver.
Acronym A randomized controlled trial for the comparison of the bleeding during hepatectomy with and without clamping the inferior vena cava below the liver.
Scientific Title A randomized controlled trial for the comparison of the bleeding during hepatectomy with and without clamping the inferior vena cava below the liver.
Scientific Title:Acronym A randomized controlled trial for the comparison of the bleeding during hepatectomy with and without clamping the inferior vena cava below the liver.
Region
Japan

Condition
Condition The patient who need open hepatectomy.
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the reduction of blood loss and the safety with or without clamping the inferior vena cava below the liver.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction of the blood loss during hepatectomy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 IVC clamp group
The patients of this group will undergo the intermittent IVC clamp during liver resection.
Interventions/Control_2 Control group
The patients of this group will not undergo the IVC clamp during liver resection.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The patients who undergo the hepatectomy.
Key exclusion criteria The patient whose preoperative creatinine clearance below 50 ml/min.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Kumamoto
Organization Yokohama city university graduate school of medicine
Division name Department of gastroenterological surgery
Zip code
Address 3-9, Hukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2650
Email kumamoto@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Kumamoto
Organization Yokohama city university graduate school of medicine
Division name Department of gastroenterological surgery
Zip code
Address -9, Hukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2650
Homepage URL
Email kumamoto@yokohama-cu.ac.jp

Sponsor
Institute Yokohama city university graduate school of medicine
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
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
2010 Year 03 Month 15 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 Open public recruiting
Date of protocol fixation
2010 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 11 Day
Last modified on
2014 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004028

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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