UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023984 |
|---|---|
| Receipt number | R000027574 |
| Scientific Title | Near-infrared fluorescence guided pulmonary segmentectomy following transbronchial indocyanine green injection using navigational bronchoscopy |
| Date of disclosure of the study information | 2016/09/08 |
| Last modified on | 2018/09/10 10:07:45 |
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Basic information
Public title
Near-infrared fluorescence guided pulmonary segmentectomy following transbronchial indocyanine green injection using navigational bronchoscopy
Acronym
Near-infrared fluorescence guided pulmonary segmentectomy following transbronchial indocyanine green injection using navigational bronchoscopy
Scientific Title
Near-infrared fluorescence guided pulmonary segmentectomy following transbronchial indocyanine green injection using navigational bronchoscopy
Scientific Title:Acronym
Near-infrared fluorescence guided pulmonary segmentectomy following transbronchial indocyanine green injection using navigational bronchoscopy
Region
| Japan |
Condition
Condition
Malignant pulumonary nodule
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the safety of near-infrared fluorescence guided pulmonary segmentectomy following transbronchial indocyanine green injection using navigational bronchoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sice effect of transbronchial indocyanine green injection to evaluate the safety of this technique
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
| Maneuver |
Interventions/Control_1
Transbronchial indocyanine green injection using navigational bronchoscopy followed by intraoperative fluorescence imaging using a near-infrared fluroescence thoracoscopy
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. Patients eligible for pulmonary segmentectomy for pulmonary malignancy or suspected lesions
2. Tumor size with a diameter of 3cm or lower
3. 20 years old or older
4. ECOG performance status 0-1
5. No definitive organd dysfuntion
6. Written consent obtaiend for this study
Key exclusion criteria
1. Allergy for indocyanine green
2. Hypersensictivity against iodine
3. Interstitial pneumonia or pulmonary fibrosis
4. Poor pulmonary function
5. Cognitive impairment
6. Pregnancy or breast-feeding
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yoshino |
Organization
Chiba University Hospital
Division name
General Thoracic Surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
0432227171
iyoshino@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Wada |
Organization
Chiba University Hospital
Division name
General Thoracic Surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba
TEL
0432227171
Homepage URL
Hironobu.Wada@chiba-u.jp
Sponsor or person
Institute
General Thoracic Surgery, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 09 | Month | 08 | 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
Navigational bronchoscopy-guided endobronchial indocyanin injection followed by intraoperative near-infrared thoracoscopy was demonsrated to be feasible and safe. This technique was useful to determine intersegmental plains during pulmonary segmetectomy.
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 21 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 21 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 08 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027574
| 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 |
