UMIN-CTR Clinical Trial

Basic information
Public title	Accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine
Acronym	Accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine (MIPS5)
Scientific Title	Accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine
Scientific Title:Acronym	Accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine (MIPS5)
Region	Japan

Condition
Condition	Liver tumors
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The fluorescence area ratio of both resected and remnant liver using conventional near-infrared fluorescence color 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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	To use the unapproved 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	90 years-old >
Gender	Male and Female
Key inclusion criteria	An anatomic left trisectionectomy, a right hepatectomy, a left hepatectomy or a right posterior sectionectomy was planned. Written informed consent.
Key exclusion criteria	Pregnancy or suspicion of pregnancy. History of hypersensitivity to ICG.
Target sample size	2

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Seo
Organization	Kyoto University Hospital
Division name	Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code	6068507
Address	54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL	075-751-3242
Email	rutosa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Nishino
Organization	Kyoto University Hospital
Division name	Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code	6068507
Address	54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL	075-751-3242
Homepage URL
Email	hnishino@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Institute
Department

Funding Source
Organization	Panasonic Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Mitaka Kohki Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address	Yoshidakonoecho Sakyo-ku Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs052180025
Org. issuing International ID_1	Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2019 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	2
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	2019 Year 01 Month 07 Day
Date of IRB	2019 Year 01 Month 07 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2019 Year 07 Month 29 Day
Date of closure to data entry	2019 Year 07 Month 29 Day
Date trial data considered complete	2019 Year 07 Month 29 Day
Date analysis concluded	2019 Year 08 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 01 Month 08 Day
Last modified on	2019 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037548