UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026238 |
|---|---|
| Receipt number | R000030101 |
| Scientific Title | The utility of indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy for lung tumor |
| Date of disclosure of the study information | 2017/02/21 |
| Last modified on | 2019/08/26 13:37:21 |
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Basic information
Public title
The utility of indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy for lung tumor
Acronym
Indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy
Scientific Title
The utility of indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy for lung tumor
Scientific Title:Acronym
Indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy
Region
| Japan |
Condition
Condition
Lung tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is identification of actual anatomical line for pulmonary segmentectomy. Indocyanin green(ICG) and Storz Professional Imaga Enhancement System(SPIES) will visualize the blood flow of pulmonary, and determine the actual anatomical line for segmentectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Identification of actual anatomical line for pulmonary segmentectomy
Key secondary outcomes
Adverse event
operetion time
blood loss
duration of chest drainage
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
ICG-guided pulmonary 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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Lung cancer
metastatic lung tumor
clinical stage IA
Perfomance status(ECOG) 0-1
Patients maintaing the finctions of main organs
Patients with written consent of regstration for this examination
Key exclusion criteria
Patients with high risk for registration of this examination
Patients who has an allergy for ICG
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Uramoto |
Organization
Kanazawa Medical University
Division name
Thoracic Surgery
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Ishikawa, Japan
TEL
076-286-2211
hidetaka@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Nozomu |
| Middle name | |
| Last name | Motono |
Organization
Kanazawa Medical University
Division name
Thoracic Surgery
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Ishikawa, Japan
TEL
076-286-2211
Homepage URL
motono@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Department Thoracic Surgery
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Department 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
Institutional Review Boards of Kanazawa Medical University
Address
1-1 Daigaku, Uchinada, Ishikawa, Japan
Tel
0762862211
tiken@kanazawa-med.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
金沢医科大学病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 21 | 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
36
Results
Lung segmentectomy NIR fluorescence imaging with ICG was performed in 36 patients. The identification of the target segmental line was possible in 34 (94%) of the 36 patients.
Results date posted
| 2019 | Year | 08 | Month | 26 | Day |
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030101
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
