UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025300 |
|---|---|
| Receipt number | R000029104 |
| Scientific Title | Exploratory study of indocyanine green fluorescence imaging for evaluation of lymph flow in laparoscopic colorectal cancer surgery |
| Date of disclosure of the study information | 2016/12/17 |
| Last modified on | 2019/06/19 19:00:09 |
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Basic information
Public title
Exploratory study of indocyanine green fluorescence imaging for evaluation of lymph flow in laparoscopic colorectal cancer surgery
Acronym
Exploratory study of indocyanine green fluorescence imaging for evaluation of lymph flow in laparoscopic colorectal cancer surgery
Scientific Title
Exploratory study of indocyanine green fluorescence imaging for evaluation of lymph flow in laparoscopic colorectal cancer surgery
Scientific Title:Acronym
Exploratory study of indocyanine green fluorescence imaging for evaluation of lymph flow in laparoscopic colorectal cancer surgery
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical usefulness of fluorescence ICG imaging with an endoscopic fluorescence imaging system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification rate of lymph flow during laparoscopic colorectal cancer surgery
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
| Medicine |
Interventions/Control_1
ICG injection into the submucosa
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) Histologically diagnosed colorectal cancer patients
2) 20 years of age and older
3) Informed consent
Key exclusion criteria
Not suitable for this study judged by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Kawamura |
Organization
Kindai University Faculty of Medicine
Division name
Surgery
Zip code
5898511
Address
377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL
072-366-0221
kawamuraj@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Kawamura |
Organization
Kindai University Faculty of Medicine
Division name
Surgery
Zip code
5898511
Address
377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL
072-366-0221
Homepage URL
kawamuraj@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kindai University Faculty of Medicine
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
Kindai University Faculty of Medicine
Address
377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
Tel
072-366-0221
zizen@med.kindai.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 | 12 | Month | 17 | 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
| 2016 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 19 | 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 | 12 | Month | 16 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029104
