UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory research of using Real-time Virtual Sonography for hepato-biliary-pancreatic surgery
Acronym	Exploratory research of using RVS for hepato-biliary-pancreatic surgery
Scientific Title	Exploratory research of using Real-time Virtual Sonography for hepato-biliary-pancreatic surgery
Scientific Title:Acronym	Exploratory research of using RVS for hepato-biliary-pancreatic surgery
Region	Japan

Condition
Condition	Hepato-Biliary-Pancreatic disease.
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the accuracy of navigation system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The error of navigation system.
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Use the navigation system for operation and evaluate the usefulness.
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	The patient who will undergo hepato-biliary-pancreatic surgery, and who can undergo CT or MRI before operation.
Key exclusion criteria	The patient who was inserted pacemaker.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norihiro Kokudo
Organization	Graduate school of Medicine, University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division, Arterial Organ and Transplantation Division, Department of Surgery
Zip code
Address	7-3-1, Hongo, Bunkyou-ku, Tokyo
TEL	03-3815-5411
Email	MIYATAA-SUR@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akinori Miyata
Organization	Graduate school of Medicine, University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division, Arterial Organ and Transplantation Division
Zip code
Address	7-3-1, Hongo, Bunkyou-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	MIYATAA-SUR@h.u-tokyo.ac.jp

Sponsor
Institute	Graduate school of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization	Hepato-Biliary-Pancreatic Surgery Division, Arterial Organ and Transplantation Division,Graduate school of Medicine, University of Tokyo
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	2014 Year 12 Month 17 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	Completed
Date of protocol fixation	2014 Year 12 Month 17 Day
Date of IRB	2014 Year 12 Month 03 Day
Anticipated trial start date	2014 Year 12 Month 17 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 12 Month 13 Day
Last modified on	2020 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018454