UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002284 |
|---|---|
| Receipt number | R000002781 |
| Scientific Title | The study of navigation surgery using Indocyanine Green fluorescence for evaluating vascular or lymphatic perfusion. |
| Date of disclosure of the study information | 2009/08/03 |
| Last modified on | 2015/08/03 09:58:09 |
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Basic information
Public title
The study of navigation surgery using Indocyanine Green fluorescence for evaluating vascular or lymphatic perfusion.
Acronym
Indocyanine Green fluorescence navigation surgery for vascular or lymphatic perfusion.
Scientific Title
The study of navigation surgery using Indocyanine Green fluorescence for evaluating vascular or lymphatic perfusion.
Scientific Title:Acronym
Indocyanine Green fluorescence navigation surgery for vascular or lymphatic perfusion.
Region
| Japan |
Condition
Condition
peripheral vascular disease
peripheral lymphatic disease
flap surgery
vasulular insufficiency
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the operation of plastic surgery, evaluation of vascular or lymphatic perfusion is mandatory. To evaluate these status, ultrasound sonography(US), computed tomography(CT), magnetic resonance imaging(MRI), angiography(AG) are utilized. The US have an advantage with respect to evaluate dynamic perfusion of vessels and lymph channels. However, it is inadequate to estimate whole imaging of the lesion.The CT and MRI are used validly to estimate whole imaging of the lesion, however the dynamic perfusion of vessels and lymph channels are not evaluated easily with CT or MRI. The dynamic perfusion can be evaluated with AG. Performing AG is time-comsuming. CT and AG have another difficulty of the radioactive exposure.
Indocyanine Green (ICG) expresses fluorescent character when ICG is injected to biological body. This fluorescent character can be examined with near infrared camera (Photodynamic Eye, PDE, ). To use ICG and PDE, the status of vessels and lymph channels can be easily evaluated as follows; dynamic perfusion, whole imaging. This technique is less-invasive, not time-comsuming,have few complications, and require no radioactive exposure.The intraoperative imaging of lesion can be possible.
In this study, The efficacy of ICG fluorescent imaging is analyzed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ability to evaluate whole imaging and dynamic status of vessels and lymph channels.
The ability to evaluate intraoperative and postoperative vascular channels of flaps.
The abilty to evaluate vascular insufficiency.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
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
| 0 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient with peripheral vascular disease or peripheral lymphatic disease
The patient who is undertaken flap surgery
The patient with vascular insufficiency
Key exclusion criteria
The patient with previous illness of ICG anaphylaxis.
The patient with previous illness of iodine anaphylaxis.
The pregnant female.
The nursing female.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunobu Hashikawa |
Organization
Kobe University Hospital
Division name
Plastic Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5111
kazunobu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruo Ogawa |
Organization
Kobe University Hospital
Division name
Plastic Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5111
Homepage URL
yeraishan@yahoo.co.jp
Sponsor or person
Institute
Department of Plastic Surgery, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2009 | Year | 08 | Month | 03 | 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
| 2009 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 03 | Day |
Last modified on
| 2015 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002781
