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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013112
Receipt No. R000015298
Scientific Title Evaluation of clinical applications of fluorescent imaging to liver surgery using injection of indocyanine green on the previous day of the operation
Date of disclosure of the study information 2014/04/01
Last modified on 2016/04/05

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Basic information
Public title Evaluation of clinical applications of fluorescent imaging to liver surgery using injection of indocyanine green on the previous day of the operation
Acronym Injection of indocyanine green on the previous day for the detection of small liver cancers
Scientific Title Evaluation of clinical applications of fluorescent imaging to liver surgery using injection of indocyanine green on the previous day of the operation
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Masaki Kaibori
Organization Kansai Medical University
Division name Surgery
Zip code
Address 2-5-1 Shinmachi, Hirakata city, Osaka
TEL 072-804-0101
Email kaibori@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Matsui
Organization Kansai Medical University
Division name Surgery
Zip code
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

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)

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 04 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
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 Enrolling by invitation
Date of protocol fixation
2014 Year 02 Month 09 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015298

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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