UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003465 |
|---|---|
| Receipt number | 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 12:58:49 |
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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
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
kbys@shinshu-u.ac.jp
Sponsor or person
Institute
Gastrointestinal Surgery, Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004194
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
