UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017480 |
|---|---|
| Receipt number | R000020256 |
| Scientific Title | Indocyanine Green (ICG) Fluorescence Angiography for Quantitative Evaluation of Viability of Esophageal Substitute in Patients Undergoing Esophagectomy |
| Date of disclosure of the study information | 2015/05/09 |
| Last modified on | 2019/05/17 16:37:55 |
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Basic information
Public title
Indocyanine Green (ICG) Fluorescence Angiography for Quantitative Evaluation of Viability of Esophageal Substitute in Patients Undergoing Esophagectomy
Acronym
ICG Fluorescence Angiography for Evaluation of Viability of Esophageal Substitute
Scientific Title
Indocyanine Green (ICG) Fluorescence Angiography for Quantitative Evaluation of Viability of Esophageal Substitute in Patients Undergoing Esophagectomy
Scientific Title:Acronym
ICG Fluorescence Angiography for Evaluation of Viability of Esophageal Substitute
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Quantitative assessment of blood flow with ICG fluorescence imaging to evaluate viability of esophageal substitute
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
luminance assessed by ICG angiography, rate of anastomotic leakage
Key secondary outcomes
in-hospital days, kinds of complications, duration of complication healing
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients undergoing esophageal reconstruction
2) patients who understand purpose of study and reveive informed consent
3) patents with 20 years old or older
Key exclusion criteria
1) patients who have allergy to ICG
2) patients who are judged to be ineligible for subject by researcher
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Maehara |
Organization
Kyushu University
Division name
Department of Surgery and Science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5466
maehara@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saeki |
Organization
Kyushu University
Division name
Department of Surgery and Science
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5466
Homepage URL
h-saeki@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery and Science, Kyushu University
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
| 2015 | Year | 05 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2015 | Year | 05 | Month | 09 | Day |
Last modified on
| 2019 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020256
