UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033982 |
|---|---|
| Receipt number | R000038750 |
| Scientific Title | Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2019/03/12 00:03:31 |
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Basic information
Public title
Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer
Acronym
Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer
Scientific Title
Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer
Scientific Title:Acronym
Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the real time identification of tumor sites and lymphatic flow using the ICG in laparoscopic colorectal cancer surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The real time identification rate of tumor site and lymphatic 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
| 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 ) 20 years of age and older
2 ) Histologically diagnosed as colorectal cancer, resection is scheduled
3 ) Performance status 0 - 2
4 ) Informed consent has been obtained
Key exclusion criteria
1 )Case in which lower endoscope is difficult before surgery
2 ) Allergic hypersensitivity of the indocyanine green
3 ) Not suitable for this study judged by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1W16, Chuo-ku, Sapporo, Japan
TEL
0116112111
itakemasa@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Okita |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1W16, Chuo-ku, Sapporo, Japan
TEL
0116112111
Homepage URL
okita@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine Department of Surgery, Surgical Oncology and Science
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
Sapporo medical University Institutional Review Board
Address
South 1, West16, Chuo-ku, Sapporo, Japan
Tel
0116112111
rskk3@sapmed.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
| 2018 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038750
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
