UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Accuracy and Usability of intraoperative ultrasonography (Real-time Virtual Sonography) for liver surgery
Title of the study (Brief title)	RVS study for liver surgery
Region	Japan

Condition
Condition	liver tumor, pancreatic tumor, tumor of biliary system
Classification by specialty	Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the accuracy and clinical usability of RVS
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	positional error between CT and IOUS images
Key secondary outcomes	Requiring tim for registration time and others

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1 years-old <
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who underwent laparotomy and liver mobilization
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	Takeshi Takamoto
Organization	Japanese Red Cross Medical Center
Division name	Hepatobiliary-pancreatic and liver transplantation surgery
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL	0334001311
Email	takamoto@nifty.com

Public contact
Name of contact person	Takeshi Takamoto
Organization	Japanese Red Cross Medical Center
Division name	Hepatobiliary-pancreatic and liver transplantation surgery
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL	0334001311
Homepage URL
Email	takamoto@nifty.com

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	Hitachi Aloka Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	462
Org. issuing International ID_1	none
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（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 30 Day
Last follow-up date	2023 Year 09 Month 30 Day
Date of closure to data entry	2023 Year 09 Month 30 Day
Date trial data considered complete	2023 Year 09 Month 30 Day
Date analysis concluded	2023 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	nothing paticular

Management information
Registered date	2017 Year 04 Month 21 Day
Last modified on	2017 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031046