UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009925 |
|---|---|
| Receipt number | 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 03:09:13 |
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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
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
takamoto@nifty.com
Sponsor or person
Institute
Japanese Red Cross Medical Center, Hepatobiliary-Pancreatic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011630
