UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021834 |
|---|---|
| Receipt number | R000025173 |
| Scientific Title | Clinical validation of intraoperative indcyanine-green(ICG) fluorescence imaging in hepatecomy. |
| Date of disclosure of the study information | 2016/04/11 |
| Last modified on | 2020/08/09 15:32:57 |
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Basic information
Public title
Clinical validation of intraoperative indcyanine-green(ICG) fluorescence imaging in hepatecomy.
Acronym
Validation of ICG fluorescence imaging in hepatecomy.
Scientific Title
Clinical validation of intraoperative indcyanine-green(ICG) fluorescence imaging in hepatecomy.
Scientific Title:Acronym
Validation of ICG fluorescence imaging in hepatecomy.
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for the efficacy of ICG fluorescence imaging in hepatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visualization of boundary between liver segments and hepatic vein-congestion area
Key secondary outcomes
identification of liver tumor
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
| 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients performed hepatectomy from April 2016 to March 2018
Key exclusion criteria
1)patients resected other organs except for colorectum and gallbradder
2)patients who have a history risked postoperative complication
3)patients regarded as ineligible by principal investigator or researcher
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Shirabe |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma, JAPAN
TEL
027-220-8800
kshirabe@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Araki |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma, JAPAN
TEL
027-220-8800
Homepage URL
karaki@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi city, GUNMA
Tel
027-220-7111
irb-jimukk-ciru@ml.gunma-u.ac.jp
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
| 2016 | Year | 04 | Month | 11 | 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
14
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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2016 | Year | 04 | Month | 08 | Day |
Last modified on
| 2020 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025173
| 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 |
