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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003465
Receipt No. R000004194
Scientific Title Evaluation of congested area of the liver using a fluorescence imaging system
Date of disclosure of the study information 2011/04/01
Last modified on 2017/04/14

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Basic information
Public title Evaluation of congested area of the liver using a fluorescence imaging system
Acronym Evaluation of congested area of the liver using a fluorescence imaging system
Scientific Title Evaluation of congested area of the liver using a fluorescence imaging system
Scientific Title:Acronym Evaluation of congested area of the liver using a fluorescence imaging system
Region
Japan

Condition
Condition liver cancer, donor of the LDLT
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate drainage territory of the hepatic veins using a ICG fluorescence imaging system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes congested area
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 evaluation of the congested area after the injection of ICG using fluorescent imaging system.ICG dose of 1mg is injected intravenouly during operation.
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

Not applicable
Gender Male and Female
Key inclusion criteria Cases of hepatectomy concnmitant with major hepatic veins, scheduled for the treatment of liver cancer or donor of the LDLT in our department
Key exclusion criteria If the patient has the history of severe allergy for ICG,

If the patients do not agree,
the patients will be excluded from this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Miyagawa
Organization Shinshu University School of Medicine
Division name Gastrointestinal Surgery
Zip code
Address 3-1-1, Asahi, Matsumoto
TEL 0263372654
Email kbys@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kobayashi
Organization Shinshu University School of Medicine
Division name Gastrointestinal Surgery
Zip code
Address 3-1-1, Asahi, Matsumoto
TEL 0263-37-2654
Homepage URL
Email kbys@shinshu-u.ac.jp

Sponsor
Institute Gastrointestinal Surgery, Shinshu University School of Medicine
Institute
Department

Funding Source
Organization none
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
2011 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 Terminated
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 04 Month 09 Day
Last modified on
2017 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004194

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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