UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Function evaluation of the new intraoperative projector machine using a fluorescence color system
Title of the study (Brief title)	Function evaluation of the new intraoperative projector machine using a fluorescence color system (MIPS2)
Region	Japan

Condition
Condition	Donor and recipient of living donor liver transplantation, multiple liver metastases
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the diagnostic accuracy of a near-infrared fluorescence color system
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of perfusion area of graft liver in liver transplantation surgery, visualization of the tumors which are difficult to recognize with the naked eyes
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	Device,equipment
Interventions/Control_1	To use the projector machine using a fluorescence color system
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	Written informed consent
Key exclusion criteria	Pregnancy or suspicion of pregnancy. History of hypersensitivity to ICG.
Target sample size	20

Research contact person
Name of lead principal investigator	Satoru Seo
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Address	54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL	075-751-3608
Email	etsu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hiroto Nishino
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Address	54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL	075-751-3608
Homepage URL
Email	hnishino@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Kyoto University Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Yamada Shadowless Lamp Corporation Panasonic Corporation
Name of secondary funｄer(s)

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	2016 Year 02 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 29 Day
Anticipated trial start date	2016 Year 02 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 04 Day
Last modified on	2018 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023632