UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030165 |
|---|---|
| Receipt number | R000034409 |
| Scientific Title | Exploratory clinical study of lymphatic and blood flow evaluation by indocyanine-green fluorescence imaging in esophageal cancer operation |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2018/09/19 12:26:41 |
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Basic information
Public title
Exploratory clinical study of lymphatic and blood flow evaluation by indocyanine-green fluorescence imaging in esophageal cancer operation
Acronym
Exploratory clinical study of lymphatic and blood flow evaluation by indocyanine-green fluorescence imaging in esophageal cancer operation
Scientific Title
Exploratory clinical study of lymphatic and blood flow evaluation by indocyanine-green fluorescence imaging in esophageal cancer operation
Scientific Title:Acronym
Exploratory clinical study of lymphatic and blood flow evaluation by indocyanine-green fluorescence imaging in esophageal cancer operation
Region
| Japan |
Condition
Condition
Esophageal cancer patient whose assigned to surgical treatment
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of lymphatic flow imaging on blood flow evaluation using indocyanine-green fluorescence imaging(IGFI) in esophageal cancer patients.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visibility of the blood flow pattern after lymphatic imaging.
Key secondary outcomes
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
indocyanine green
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
Esophageal cancer patients whose assigned to surgical resection
1) 20yrs and older
2) PS(ECOG Performance status) 0 or 1
3) favorable major organ function
Key exclusion criteria
1) past history of ICG or Iodine hypersensitivity
2) pregnant patient
3) breast feeding patient
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Seto |
Organization
University of Tokyo Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
7-3-1, Bunkyo-ku Hongou, Tokyo
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryohei Iwata |
Organization
University of Tokyo Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
7-3-1, Bunkyo-ku Hongou, Tokyo
TEL
03-3815-5411
Homepage URL
IWATAR-SUR@h.u-tokyo.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo Hospital
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | 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
| 2017 | Year | 11 | Month | 29 | Day |
Last modified on
| 2018 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034409
