UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030486 |
|---|---|
| Receipt number | R000033365 |
| Scientific Title | Intraoperative indocyanine green in general thoracic surgery |
| Date of disclosure of the study information | 2017/12/24 |
| Last modified on | 2019/12/21 22:20:53 |
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Basic information
Public title
Intraoperative indocyanine green in general thoracic surgery
Acronym
Intraoperative indocyanine green in general thoracic surgery
Scientific Title
Intraoperative indocyanine green in general thoracic surgery
Scientific Title:Acronym
Intraoperative indocyanine green in general thoracic surgery
Region
| Japan |
Condition
Condition
Patients who undergo pulmonary segmentectomy and in whom intraoperative and intravenous indocyanine green may guide intersegmental borders
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To aim to evaluate the efficacy of intraoperative and intravenous indocyanine green in pulmonary segmentectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase I,II
Assessment
Primary outcomes
The efficacy of intraoperative indocyanine green in identifying intersegmental borders for pulmonary segmentectomy
Key secondary outcomes
Adverse events and complications in intravenous administration of indocyanine green
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 | Device,equipment |
Interventions/Control_1
intravenous administration of 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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
segmentectomy wedge resection
Key exclusion criteria
lobectomy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toyofumi-Fengshi |
| Middle name | |
| Last name | Chen-Yoshikawa |
Organization
Kyoto University
Division name
Thoracic Surgery
Zip code
6068507
Address
Sakyo-ku
TEL
075-751-4975
mhamaji@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Toyofumi-Fengshi |
| Middle name | |
| Last name | Chen-Yoshikawa |
Organization
Kyoto University
Division name
Thoracic Surgery
Zip code
606-8507
Address
Sakyo-ku
TEL
075-751-4975
Homepage URL
mhamaji@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
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
Kyoto University Hospital Ethical Committe
Address
54 Kawahara-cho, Shogoin, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 20 | 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 | 12 | Month | 20 | Day |
Last modified on
| 2019 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033365
