UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026728 |
|---|---|
| Receipt number | R000030687 |
| Scientific Title | Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery |
| Date of disclosure of the study information | 2017/03/29 |
| Last modified on | 2017/03/28 01:29:47 |
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Basic information
Public title
Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Acronym
Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Scientific Title
Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Scientific Title:Acronym
Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the intestinal and mesenteric lymph flow using the ICG fluorescence method in a colorectal cancer surgery
Basic objectives2
Others
Basic objectives -Others
Evaluation of the intestinal blood flow near the anastomosis using the ICG fluorescence method in a colorectal cancer surgery
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1 Identification rate of lymphatic vessels and fluorescent lymph nodes near the tumor.
2 Evaluation of blood flow of the anastomotic site
Key secondary outcomes
1 Identification rate of sentinel lymph node
2 Number of fluorescent lymph node/ number of removal lymph node
3 Incidence rate of anastomotic leakage
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
1 Indocyanine green local injection at the colorectal surgery
2 Indocyanine green intravenous injection at the colorectal 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Colorectal cancer surgery patient
2 Written informed consent
Key exclusion criteria
1 Allergic hypersensitivity of the indocyanine green
2 Cases of incapacity decided by attending physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Ueda |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
Address
840 Shijocho Kashihara,Nara,Japan
TEL
0744-22-3051
takeueda@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ueda |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
Address
840 Shijocho Kashihara, Nara
TEL
0744-22-3051
Homepage URL
takeueda@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
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
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
奈良県立医科大学付属病院(奈良県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 29 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2017 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030687
