UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045238 |
|---|---|
| Receipt number | R000051598 |
| Scientific Title | Evaluation of the lymph flow using Indocyanine green (ICG) fluorescence during colorectal surgery |
| Date of disclosure of the study information | 2021/08/25 |
| Last modified on | 2022/02/22 16:35:00 |
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Basic information
Public title
Evaluation of the lymph flow using Indocyanine green (ICG) fluorescence during colorectal surgery
Acronym
Evaluation of the lymph flow using Indocyanine green (ICG) fluorescence during colorectal surgery
Scientific Title
Evaluation of the lymph flow using Indocyanine green (ICG) fluorescence during colorectal surgery
Scientific Title:Acronym
Evaluation of the lymph flow using Indocyanine green (ICG) fluorescence during colorectal surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the appropriate area of lymph node dissection in colorectal cancer surgery using ICG imaging method
Basic objectives2
Others
Basic objectives -Others
Existence of errant lymph flow
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of the additional dissected lymph node metastasis
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection of ICG (2.5mg/ml) for the assessment of lymph flow at the begining of colorectal cancer surgery
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
Colorectal cancer patients who are planed to receive laparoscopic colectomy / proctectomy with lymph node dissection
Key exclusion criteria
Patients with ICG allergy
Patients with iodine allergy
Recurrent cases
Patients who are planed to receive palliative surgery
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nishikawa |
Organization
Saitama Cancer Center
Division name
Department of gastrointestinal surgery
Zip code
3620806
Address
780 Komuro, Ina-town, Kitaadachi-gun, Saitama, 362-0806
TEL
+81-48-722-1111
tnishikawa@saitama-pho.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nishikawa |
Organization
Saitama Cancer Center
Division name
Department of gastrointestinal surgery
Zip code
3620806
Address
780 Komuro, Ina-town, Kitaadachi-gun, Saitama, 362-0806
TEL
+81-48-722-1111
Homepage URL
tnishikawa@saitama-pho.jp
Sponsor or person
Institute
Saitama Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Cancer Center
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
Saitama Cancer Center
Address
780 Komuro, Ina-town, Kitaadachi-gun, Saitama, 362-0806
Tel
+81-48-722-1111
g.sccctmo01@saitama-pho.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
| 2021 | Year | 08 | Month | 25 | 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
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2027 | 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
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051598
