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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030486
Receipt No. R000033365
Scientific Title Intraoperative indocyanine green in general thoracic surgery
Date of disclosure of the study information 2017/12/24
Last modified on 2019/06/22

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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

Not applicable
Age-upper limit

Not applicable
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
Email 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
Email mhamaji@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033365

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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