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

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 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


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

Value
https://center6.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