UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024383 |
|---|---|
| Receipt number | R000028070 |
| Scientific Title | Evaluation of the blood flow of the reconstructed organs using ICG fluorescence method during esophagectomy (Multi-center study) |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2018/10/11 14:31:30 |
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Basic information
Public title
Evaluation of the blood flow of the reconstructed organs using ICG fluorescence method during esophagectomy (Multi-center study)
Acronym
Evaluation of the blood flow of the reconstructed organs using ICG fluorescence method during esophagectomy
Scientific Title
Evaluation of the blood flow of the reconstructed organs using ICG fluorescence method during esophagectomy (Multi-center study)
Scientific Title:Acronym
Evaluation of the blood flow of the reconstructed organs using ICG fluorescence method during esophagectomy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Using ICG fluorescence technique, we can visualize the well perfusion site of blood for reconstructed organs during esophagectomy. Thus, we can determine the adequate site for anastomosis. The aim of this study is to confirm the reproducibility of this technique with high volume centers of Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of leakage of anastomosis
Key secondary outcomes
Factors affecting blood flow at the tip of the reconstructed organs
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
ICG fluorescence method
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
Patients who receive esophageal reconstruction using gastric tube or small bowel or colon.
Key exclusion criteria
Patients who have past history of allergy for ICG
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Youichi Kumagai |
Organization
Saitama Medical Center
Division name
Department of the digestive tract and general surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama, Japan
TEL
049-228-3619
kuma7srg1@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Youichi Kumagai |
Organization
Saitama Medical Center
Division name
Department of the digestive tract and general surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama, Japan
TEL
049-228-3619
Homepage URL
kuma7srg1@gmail.com
Sponsor or person
Institute
Department of the digestive tract and general surgery, Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of the digestive tract and general surgery, Saitama Medical Center
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
東京医科歯科大学 消化管一般外科学、がん・感染症センター都立駒込病院 外科、
太田総合病院付属太田西ノ内病院 外科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 01 | 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
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | 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 | 10 | Month | 12 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028070
| 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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