UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007079 |
|---|---|
| Receipt number | R000008336 |
| Scientific Title | Effect of Intraoperative indocyanine green fluorescent imaging in liver surgery: a randamised study |
| Date of disclosure of the study information | 2012/01/18 |
| Last modified on | 2020/04/06 13:35:39 |
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Basic information
Public title
Effect of Intraoperative indocyanine green fluorescent imaging in liver surgery: a randamised study
Acronym
indocyanine green fluorescent imaging in liver surgery
Scientific Title
Effect of Intraoperative indocyanine green fluorescent imaging in liver surgery: a randamised study
Scientific Title:Acronym
indocyanine green fluorescent imaging in liver surgery
Region
| Japan |
Condition
Condition
elective liver surgery
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the effectivenes of Intraoperative indocyanine green fluorescent imaging to prevent bile leakage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
rate of bile leakage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
perform the leak-test with intraoperative cholangiography, indigocarmine and indocyanin green.
Interventions/Control_2
perform the leak-test with intraoperative cholangiography, indigocarmine.
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
elective liver surgery
Key exclusion criteria
surgery with biliary reconstruction
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuniya Tanaka |
Organization
Yokohama City University Hospital
Division name
Yokohama City Universit, Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004, Japan
TEL
045-787-2650
t.kumamoto@k5.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Kumamoto |
Organization
Yokohama City University Hospital
Division name
3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004, Japan
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004, Japan
TEL
045-787-2650
Homepage URL
t.kumamoto@k5.dion.ne.jp
Sponsor or person
Institute
Yokohama City Universit, Gastroenterological surgery
Institute
Department
Personal name
Funding Source
Organization
Yokohama City Universit, Gastroenterological surgery
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
| 2012 | Year | 01 | Month | 18 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008336
