UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021284 |
|---|---|
| Receipt number | R000024545 |
| Scientific Title | Intraoperative identification of colonic tumor site using near infrared indocyanine green-induced endosopic fluorescence imaging system |
| Date of disclosure of the study information | 2016/03/02 |
| Last modified on | 2016/03/02 13:30:40 |
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Basic information
Public title
Intraoperative identification of colonic tumor site using near infrared indocyanine green-induced endosopic fluorescence imaging system
Acronym
Colonic tatooing using ICG-induced endosopic fluorescence imaging system
Scientific Title
Intraoperative identification of colonic tumor site using near infrared indocyanine green-induced endosopic fluorescence imaging system
Scientific Title:Acronym
Colonic tatooing using ICG-induced endosopic fluorescence imaging system
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the intraoperative identification of colonic tumor site in colorectal surgery using endoscopic near-infrared fluorescence imaging system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The intraoperative visibility rate of tumor site
Key secondary outcomes
Complications of ICG injection
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
0.5 ml ICG was injected the mucosa into the submucosal space of the bowel wall at just the distal side of the tumor preoperative endoscopically. We identified the colonic tumor site in the PINPOINT Endoscopic Fluorescence Imaging System, in which NIR fluorescence is superimposed in pseudo-color (green) on a white light image.
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
Colorectal cancer patients that laparoscopic surgery has been scheduled.
Key exclusion criteria
Emergency operation, ileus, Open surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Watanabe |
Organization
Showa University
Division name
Department of Gastroenterological & General Surgery
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
+81-3-3784-8541
m-watanabe@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Watanabe |
Organization
Showa University
Division name
Department of Gastroenterological & General Surgery
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
+81-3-3784-8541
Homepage URL
m-watanabe@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Department of Gastroenterological and General Surgery
Institute
Department
Personal name
Funding Source
Organization
Showa University Department of Gastroenterological and General Surgery
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 03 | Month | 02 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | 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
| 2016 | Year | 03 | Month | 02 | Day |
Last modified on
| 2016 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024545
