UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of clinical applications of fluorescent imaging to liver surgery using injection of indocyanine green on the previous day of the operation
Title of the study (Brief title)	Injection of indocyanine green on the previous day for the detection of small liver cancers
Region	Japan

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

Objectives
Narrative objectives1	The detection of small liver cancers using indocyanine green fluorescent imaging through the injection of indocyanine green on the previous day
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	The detection of small liver cancers
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	indocyanine green
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Written informed concent
Key exclusion criteria	Other conditions considered inappropriate by attending physician
Target sample size	100

Research contact person
Name of lead principal investigator	Masaki Kaibori
Organization	Kansai Medical University
Division name	Surgery
Address	2-5-1 Shinmachi, Hirakata city, Osaka
TEL	072-804-0101
Email	kaibori@hirakata.kmu.ac.jp

Public contact
Name of contact person	Kosuke Matsui
Organization	Kansai Medical University
Division name	Surgery
Address	2-5-1 Shinmachi, Hirakata city, Osaka
TEL	072-804-0101
Homepage URL
Email	matsuik@hirakata.kmu.ac.jp

Sponsor
Institute	Department of Surgery, Kanai Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Surgery, Kanai Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2014 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 02 Month 09 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
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	2014 Year 02 Month 09 Day
Last modified on	2016 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000015298