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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009925
Receipt No. R000011630
Scientific Title standardization of parabolical liver resection using 3D simulation software
Date of disclosure of the study information 2013/02/01
Last modified on 2014/08/03

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Basic information
Public title standardization of parabolical liver resection using 3D simulation software
Acronym standardization of parabolical liver resection
Scientific Title standardization of parabolical liver resection using 3D simulation software
Scientific Title:Acronym standardization of parabolical liver resection
Region
Japan

Condition
Condition liver tumors
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the execution of limited liver resection (parabolical shape) planned by 3D simulation software
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Execution of limited liver resection (parabolical shape) planned by 3D simulation software
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 execution of palabolical liver resection planned 3D simulation software
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing limited resection for liver tumors
Key exclusion criteria Patient who had allergy to the iodine contrast matter.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Takamoto
Organization Japanese Red Cross Medical Center
Division name Hepatobiliary-Pancreatic Surgery
Zip code
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Email takamoto@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Takamoto
Organization Japanese Red Cross Medical Center
Division name Hepatobiliary-Pancreatic Surgery
Zip code
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Homepage URL
Email takamoto@nifty.com

Sponsor
Institute Japanese Red Cross Medical Center, Hepatobiliary-Pancreatic Surgery
Institute
Department

Funding Source
Organization Japanese Red Cross Medical Center, Hepatobiliary-Pancreatic Surgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 日本赤十字社医療センター

Other administrative information
Date of disclosure of the study information
2013 Year 02 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 Open public recruiting
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 02 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
2013 Year 02 Month 01 Day
Last modified on
2014 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011630

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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