UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021898 |
|---|---|
| Receipt number | R000025255 |
| Scientific Title | Indocyanine green (ICG) application to intraoperative navigation of fluorescence imaging |
| Date of disclosure of the study information | 2016/04/15 |
| Last modified on | 2016/04/13 20:18:13 |
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Basic information
Public title
Indocyanine green (ICG) application to intraoperative navigation of fluorescence imaging
Acronym
Intraoperative navigation with fluorescence imaging of indocyanine green (ICG)
Scientific Title
Indocyanine green (ICG) application to intraoperative navigation of fluorescence imaging
Scientific Title:Acronym
Intraoperative navigation with fluorescence imaging of indocyanine green (ICG)
Region
| Japan |
Condition
Condition
Gastrointestinal malignant tumor
Ischemic bowel disease
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of ICG fluorescence imaging for intraoperative identifyning the tumor localization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse event
Key secondary outcomes
Intraoperative visualization rate of lesion.
Histopathological positive rate
Pathological curative resection rate
operative time, bleeding, intra and postoperative complication, recurrence rate
Resected rate
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Indocyanine green (ICG)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient who scheduled for treatment with surgery by gstroenterological malignant tumor.
A patient who need surgery due to acute intestinal ischemic bowel disease.
Key exclusion criteria
A patient who has a history of allergic reaction to the ICG.
A patient who can not obtain the consent by document.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Inomata |
Organization
Oita University
Division name
Gastrointestinal and pediatric surgery
Zip code
Address
1-1Idaigaoka Hasamamachi Yufu city, Oita, Japan
TEL
097-586-5843
geka1@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Iwashita |
Organization
Oita University
Division name
Gastrointestinal and pediatric surgery
Zip code
Address
1-1Idaigaoka Hasamamachi Yufu city, Oita, Japan
TEL
097-586-5843
Homepage URL
http://www.med.oita-u.ac.jp/surgery1/about/stuff/
geka1@oita-u.ac.jp
Sponsor or person
Institute
Oita University
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
大分大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 15 | 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
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | 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
| 2016 | Year | 04 | Month | 13 | Day |
Last modified on
| 2016 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025255
