UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039977 |
|---|---|
| Receipt number | R000045581 |
| Scientific Title | Retrospective cohort study of evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of colon cancer |
| Date of disclosure of the study information | 2020/03/30 |
| Last modified on | 2020/03/30 00:40:22 |
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Basic information
Public title
Retrospective cohort study of evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of colon cancer
Acronym
Retrospective cohort study of evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of colon cancer
Scientific Title
Retrospective cohort study of evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of colon cancer
Scientific Title:Acronym
Retrospective cohort study of evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of colon cancer
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the efficacy of ICG fluorescence imaging for preventing anastomotic leakage after laparoscopic surgery for colon cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of anastomotic leakage
Key secondary outcomes
perfusion time after ICG injection, rate of additional resection by ICG-FI, length of additional resection by ICG-FI, postoperative complications, intraoperative complications, re-operation rate, length of postoperative hospital stay, operation time, volume of blood loss, number of harvested lymph node, distal margin, proximal margin, 3-year local recurrence rate, 3-year relapse-free survival, 3-year overall survival
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
ING intravenous administration
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
Laparoscopic surgery for colon cancer
Key exclusion criteria
synchronous resection of other organs
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Masui |
Organization
Yokosuka kyosai hospital
Division name
Department of surgery
Zip code
238-8558
Address
1-16 Yonegahama-dori, Yokosuka-shi, Kanagawa 238-8558
TEL
046-822-2710
hmsi@ykh.gr.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Suwa |
Organization
Yokosuka kyosai hospital
Division name
Department of surgery
Zip code
238-8558
Address
1-16 Yonegahama-dori, Yokosuka-shi, Kanagawa 238-8558
TEL
046-822-2710
Homepage URL
hiro0302.suwa@gmail.com
Sponsor or person
Institute
Yokosuka kyosai hospital
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
Yokosuka kyosai hospital clinical research ethics committee
Address
1-16 Yonegahama-dori, Yokosuka-shi, Kanagawa 238-8558
Tel
046-822-2710
syomu@ykh.gr.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
| 2020 | Year | 03 | Month | 30 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045581
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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