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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031820
Receipt No. 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

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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
Email 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
Email tokai.eso@tokai-u.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015543

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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