UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014829 |
|---|---|
| Receipt number | R000017236 |
| Scientific Title | Innovative and correct technique for identification of intersegmental planes by infrared thoracoscopy after transbronchial injection of indocianine green |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2014/08/11 14:38:39 |
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Basic information
Public title
Innovative and correct technique for identification of intersegmental planes by infrared thoracoscopy after transbronchial injection of indocianine green
Acronym
Identification of lung segment by transbronchial ICG instillation
Scientific Title
Innovative and correct technique for identification of intersegmental planes by infrared thoracoscopy after transbronchial injection of indocianine green
Scientific Title:Acronym
Identification of lung segment by transbronchial ICG instillation
Region
| Japan |
Condition
Condition
lung tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine segmental planes with infrared thoracoscopy by immediate preoperative injection of ICG into the associated bronchus prior to segmentectomy for lung tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After segmentectomy, we will evaluate the efficacy of ICG instillation for demarking segments by confirming whether residual segments which should be removed still exist and by measuring distance from the segmental plane to the tumor. After operation, we will confirm the correctness of removing the segments by computed tomography.
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
| Device,equipment |
Interventions/Control_1
Transbronchial ICG instillation to the resected segments of lung tumor
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. 20 year old or higher
2. the patients who undergo segmentectomy
3. IC was obtained
Key exclusion criteria
1. patients who do not want to entry this study
2. Allegy for iodine
3. Inappropriate patients for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Sekine |
Organization
Tokyo Womens Medical University Yachiyo Medical Center
Division name
Departments of Thoracic Surgery
Zip code
Address
477-96 Owada-Shinden, Yachiyo, Chiba, 276-8524, Japan
TEL
047-450-6000
ysekine@tymc.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Sekine |
Organization
Tokyo Womens Medical University Yachiyo Medical Center
Division name
Departments of Thoracic Surgery
Zip code
Address
477-96 Owada-Shinden, Yachiyo, Chiba, 276-8524, Japan
TEL
047-450-6000
Homepage URL
ysekine@tymc.twmu.ac.jp
Sponsor or person
Institute
Tokyo Womens Medical University Yachiyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Womens Medical 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
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
| 2014 | Year | 08 | Month | 25 | 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
| 2014 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 25 | 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
| 2014 | Year | 08 | Month | 11 | Day |
Last modified on
| 2014 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017236
