UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029159 |
|---|---|
| Receipt number | R000033341 |
| Scientific Title | Feasibility study of sentinel lymph node biopsy guided by indocyanine green fluorescence imaging for colon cancer |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2021/05/25 16:00:09 |
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Basic information
Public title
Feasibility study of sentinel lymph node biopsy guided by indocyanine green fluorescence imaging for colon cancer
Acronym
Sentinel node biopsy guided by indocyanine green fluorescence imaging for colon cancer
Scientific Title
Feasibility study of sentinel lymph node biopsy guided by indocyanine green fluorescence imaging for colon cancer
Scientific Title:Acronym
Sentinel node biopsy guided by indocyanine green fluorescence imaging for colon cancer
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To invastigate the identification rates of sentinel lymph node guided by indocyanine green fluorescence imaging
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The identification rate of sentinel lymph node
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
During cololectomy, Indocyanine green is submucosally injected via endoscopy around tumor and sentinel lymph nodes are picked up using indocyanine green fluorescence imaging.
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 proven adenocarcinoma of colon or rectum adenocarcinoma.
2) solitary tumor.
3) cT2 or cT3 or cT4a or cT4b.
4) cN0.
5) D3 lymph node dissection is planned to be performed.
6) Age of 20 years or older.
7) No history of colorectomy.
8) Written informed consent.
Key exclusion criteria
1) Allergy for indocyanine green or iodine.
2) Cannot enroll to this study for any other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Mori |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3251
mmori@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Takahashi |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3251
Homepage URL
htakahashi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School 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
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
| 2017 | Year | 10 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | 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
| 2017 | Year | 09 | Month | 15 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033341
