UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012432 |
|---|---|
| Receipt number | R000014496 |
| Scientific Title | Evaluation of clinical efficiency of intestinal tract blood flow measurement using the ICG fluorescence method in a colorectal cancer surgery |
| Date of disclosure of the study information | 2013/11/29 |
| Last modified on | 2015/07/17 16:45:32 |
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Basic information
Public title
Evaluation of clinical efficiency of intestinal tract blood flow measurement using the ICG fluorescence method in a colorectal cancer surgery
Acronym
Evaluation of clinical efficiency of intestinal tract blood flow measurement using the ICG fluorescence method
Scientific Title
Evaluation of clinical efficiency of intestinal tract blood flow measurement using the ICG fluorescence method in a colorectal cancer surgery
Scientific Title:Acronym
Evaluation of clinical efficiency of intestinal tract blood flow measurement using the ICG fluorescence method
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical efficiency of intestinal tract blood flow measuremen using the ICG fluorescence method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visibility of intestinal tract blood flow
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Intestinal tract blood flow measuremenusing the ICG fluorescence method
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
1.Scheduled for elective surgery for gastrointestinal cancer
2.Age>=20
3.Written informed consent
Key exclusion criteria
1.Allergic hypersensitivity of the indocyanine green
2.Allergic hypersensitivity of the iodine
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Sakamoto |
Organization
Juntendo University Faculty of Medicine
Division name
Department of coloproctological surgery
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
TEL
03-3813-3111
kazusaka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Takehara |
Organization
Juntendo University Faculty of Medicine
Division name
Department of coloproctological surgery
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
TEL
03-3813-3111
Homepage URL
ktakeha@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty 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
| 2013 | Year | 11 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | 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
| 2013 | Year | 11 | Month | 28 | Day |
Last modified on
| 2015 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014496
