UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036764 |
|---|---|
| Receipt number | R000041861 |
| Scientific Title | Evaluation of lymph flow patterns in colorectal cancers using real-time indocyanine green fluorescence imaging |
| Date of disclosure of the study information | 2019/05/20 |
| Last modified on | 2019/11/01 17:44:11 |
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Basic information
Public title
Lymph flow in colorectal cancers using real-time ICG imaging
Acronym
CLFP-ICG
Scientific Title
Evaluation of lymph flow patterns in colorectal cancers using real-time indocyanine green fluorescence imaging
Scientific Title:Acronym
CLFP-ICG
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the appropriate area of lymph node dissection through inta-operative visualization of lymphatic flow using ICG imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of lymph node metastasis in the additional area of lymph node dissection
Key secondary outcomes
Clinical safety, the number of dissected lymph nodes, the existence of unexpected lymphatic flow
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1 injection of indocyanine green(2.5mg/ml) into submucosa of colon and rectum in colorectal cancer patients
2 Expansion of lymph nodes dissection area according to the acquired information by indocyanine green visualization
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
colon cancer patients who are planed to receive colectomy with lymph node dissection
Key exclusion criteria
Patients with Iodine allergy
Patient with allergy to indocyanine green
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Nakanishi |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Digestive Surgery
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku Kyoto
TEL
0752515527
mnakan@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Kudou |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Digestive Surgery
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku Kyoto
TEL
0752515527
Homepage URL
posit@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery,Division of Digestive Surgery
Kyoto prefectural University 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
Kyoto Prefectural University of Medicine, Institutional Review Board,
Address
465 Kajii-cho, Kamigyo-ku Kyoto
Tel
0752515337
rinri@koto.kpu-m.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
| 2019 | Year | 05 | Month | 20 | 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
| 2019 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2019 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041861
