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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024383
Receipt No. 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

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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
Email 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
Email kuma7srg1@gmail.com

Sponsor
Institute Department of the digestive tract and general surgery, Saitama Medical Center
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028070

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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