UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031820 |
|---|---|
| Receipt number | R000015543 |
| Scientific Title | Blood flow visualization by indocyanine green (ICG) fluorescence imaging of the reconstructed substitute after the resection of esophageal cancer |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2019/03/26 21:19:22 |
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Basic information
Public title
Blood flow visualization by indocyanine green (ICG) fluorescence imaging of the reconstructed substitute after the resection of esophageal cancer
Acronym
ICG fluorescence blood flow visualization of the reconstructed substitute after esophageal cancer surgery
Scientific Title
Blood flow visualization by indocyanine green (ICG) fluorescence imaging of the reconstructed substitute after the resection of esophageal cancer
Scientific Title:Acronym
ICG fluorescence blood flow visualization of the reconstructed substitute after esophageal cancer surgery
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the clinical utility of indocyanine green(ICG) fluoresence imaging for the assessment of blood flow of reconstructed substitute after esophageal cancer surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Blood supply and microvessel network of reconstructed substitite by using ICG fluoresence.
Key secondary outcomes
Incidence of anastomotic leaks and other adverse events.
Post operative length of stay.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients with esophageal cancer who plan for the elective surgeries
(2)Patients with signed Informed consent
Key exclusion criteria
(1)Patients with impaired judgement
(2)Patients with hypersensitivity to ICG
(3)Patients with hypersensitivity to iodine
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Soji |
| Middle name | |
| Last name | Ozawa |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
sozawa@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Soji |
| Middle name | |
| Last name | Ozawa |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
tokai.eso@tokai-u.jp
Sponsor or person
Institute
Tokai University School of Medicine
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
Institutional Review Board for Clinical Research, Tokai University Hospital
Address
143 Shimokasuya, Isehara City, Kanagawa
Tel
0463931121
tokai-rinsho@ml.tokai-u.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
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Following contents of the reconstructed substitute are observed during the esophageal cancer surgery.
1. Macroscopic blood flow observation of the reconstructed substitute before esophageal anastomosis.
2. Blood flow visualization by ICG fluorescence imaging of the reconstructed substitute before esophageal anastomosis.
3. Macroscopic blood flow observation of the anastomotic part and reconstructed substitute after esophageal anastomosis.
4. Blood flow visualization by ICG fluorescence imaging of the anastomotic part and reconstructed substitute after esophageal anastomosis.
5. Incidence of anastomotic leak and other major complications.
Management information
Registered date
| 2018 | Year | 03 | Month | 20 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015543
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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