UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021575 |
|---|---|
| Receipt number | R000024754 |
| Scientific Title | Clinical research for evaluation of organ blood flow by using the ICG fluorescence method during esophagus cancer operations. |
| Date of disclosure of the study information | 2016/03/24 |
| Last modified on | 2017/04/24 12:05:45 |
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Basic information
Public title
Clinical research for evaluation of organ blood flow by using the ICG fluorescence method during esophagus cancer operations.
Acronym
Organ bloodflow evaluation by using the ICG fluorescence method
Scientific Title
Clinical research for evaluation of organ blood flow by using the ICG fluorescence method during esophagus cancer operations.
Scientific Title:Acronym
Organ bloodflow evaluation by using the ICG fluorescence method
Region
| Japan |
Condition
Condition
esophagus cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and analyze for blood flow in a gastric wall, gastric tube and the trachea by using ICG during esophagus cancer operations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
enables the observation of blood flow in a gastric wall, gastric tube and the trachea by using ICG during esophagus cancer operations.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
indocyanine green 25mg by dissolving with injection solution and use 0.5cc (1.25mg) per time when conducting chest procedure and creating gastric tube.
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 Histologically proven esophagus cancer
2 Aged over 20 at the time of registration
3 Patients conducting surgical operation for esophagus cancer
4 Written IC
Key exclusion criteria
1 Previous history of ICG allergy
2 Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kuwano |
Organization
Gunma University Hospital
Division name
Integrative Center of General Surgery
Zip code
Address
3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL
027-220-8224
maksakai@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Sakai |
Organization
Gunma University Hospital
Division name
Integrative Center of General Surgery
Zip code
Address
3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL
027-220-8224
Homepage URL
maksakai@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
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
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
群馬大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 24 | 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
Date of protocol fixation
| 2016 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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 | 03 | Month | 23 | Day |
Last modified on
| 2017 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024754
