UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031453 |
|---|---|
| Receipt number | R000035909 |
| Scientific Title | Precise anatomical lung segmentectomy by using near-infrared thoracoscopy (photodynamic eye) and transbronchial ICG instillation |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/08/27 14:37:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Precise anatomical lung segmentectomy by using near-infrared thoracoscopy (photodynamic eye) and transbronchial ICG instillation
Acronym
Lung segmentectomy by ICG fluorescence
Scientific Title
Precise anatomical lung segmentectomy by using near-infrared thoracoscopy (photodynamic eye) and transbronchial ICG instillation
Scientific Title:Acronym
Lung segmentectomy by ICG fluorescence
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 make a clear boundary line , to obtain enough margin, and to perform pricese anatomycal segmentectomy by using transbronshial instillation of ICG.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
1. To confirm pricise anatomical segmentectomy by no ICG remaining in the residual lung and by postoperative CT
2) To study for the efficucy of this method in terms of protective effect of local recurrence
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
ICG segmentectomy
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
lung malignancies
Key exclusion criteria
iodin allergy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | YASUO |
| Middle name | |
| Last name | SEKINE |
Organization
Tokyo Womens Medical University Yachiyo Medical Center
Division name
Dept. of Thoracic Surgery
Zip code
276-8524
Address
477-96 Owada-Shinden, Yachiyo, Chiba 276-8524 Japan
TEL
047-450-6000
sekine.yasuo@twmu.ac.jp
Public contact
Name of contact person
| 1st name | YASUO |
| Middle name | |
| Last name | SEKINE |
Organization
Tokyo Womens Medical University Yachiyo Medical Center
Division name
Dept. of Thoracic Surgery
Zip code
276-8524
Address
477-96 Owada-Shinden, Yachiyo, Chiba 276-8524 Japan
TEL
047-450-6000
Homepage URL
sekine.yasuo@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 Yachiyo Medical Center, Department of Thoracic Surgery
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
Tokyo Women's Medical University
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
ohta.megumi@twmu.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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 23 | Day |
Last modified on
| 2021 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035909
