UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010836 |
|---|---|
| Receipt number | R000012689 |
| Scientific Title | Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2018/02/28 20:47:24 |
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Basic information
Public title
Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Acronym
Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Scientific Title
Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Scientific Title:Acronym
Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Region
| Japan |
Condition
Condition
Pulmonary neoplasms
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To overcome the limitation of conventional CT-guided marking including complications (air emborisms, bleeding, pneumothorax) adn technical limitations (mainly due to anatomical localization of the target), by using 3D virtual bronchoscopic navigation, bronchoscopic marking is conducted and the efficacy and safety will be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Safety of bronchoscopic marking
2) Accuracy of marking
3) Efficacy as an aid for lung resection
Key secondary outcomes
Outcome of lung resection (resection with free margin) in pathology
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 | Maneuver |
Interventions/Control_1
Brpmchoscopically inject indigo carmine (0.5-1ml)to peripheral lung tissue
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
Patients who have small (=<2cm in diameter) peripheral lung nodules that are hardly palpable, or lesions with ground glass opacity (regardless of the size) for which pre-operative marking is considered to be necessary based on clinical judgement.
Key exclusion criteria
Those who have past or present medical history of asthma
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Suzuki |
Organization
Juntendo University
Division name
Department of General Thoracic Surgery
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
kjsuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Suzuki |
Organization
Juntendo University
Division name
Department of General Thoracic Surgery
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
kjsuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 29 | Day |
Last modified on
| 2018 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012689
