UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001710 |
|---|---|
| Receipt number | R000002043 |
| Scientific Title | Randomized trial of transbronchial biopsy using endobronchial ultrasonography with guide sheath (EBUS-GS) and navigation by virtual bronchoscopy or X-ray fluoroscopy for pulmonary peripheral lesions |
| Date of disclosure of the study information | 2009/02/16 |
| Last modified on | 2018/02/09 13:07:57 |
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Basic information
Public title
Randomized trial of transbronchial biopsy using endobronchial ultrasonography with guide sheath (EBUS-GS) and navigation by virtual bronchoscopy or X-ray fluoroscopy for pulmonary peripheral lesions
Acronym
Randomized trial of transbronchial biopsy using EBUS-GS and VBN or X-ray fluoroscopy for pulmonary peripheral lesions
Scientific Title
Randomized trial of transbronchial biopsy using endobronchial ultrasonography with guide sheath (EBUS-GS) and navigation by virtual bronchoscopy or X-ray fluoroscopy for pulmonary peripheral lesions
Scientific Title:Acronym
Randomized trial of transbronchial biopsy using EBUS-GS and VBN or X-ray fluoroscopy for pulmonary peripheral lesions
Region
| Japan |
Condition
Condition
peripheral pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To show that VBN can be applied instead of X-ray fluoroscopy in transbronchial biopsy using EBUS/GS for pulmonary peripheral lesions
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Yield (Diagnostic rate)
Key secondary outcomes
1)The time to reach the lesion
2)The time of first biopsy
3)The time of X-ray fluoroscopy
4)The time of total examination
5)Agreement between bronchi by virtual bronchoscopy and actual bronchi
6)Bronchial generation inserted by bronchoscopy
7)Bronchial generation observed by bronchoscopy
8)Complication
9)Pain degree subscale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
With navigation by virtual bronchoscopy
Interventions/Control_2
With X-ray fluoroscopy
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.Peripheral pulmonary lesions of 30 mm> deemed, but not determined, as lung cancer
2.Not visible by bronchoscopy
3.20 or more than 20 years of age
4.SpO2 90% or more than 90%
5.Written informed consent
Key exclusion criteria
1.Visible by bronchoscopy
2.GGO
3.Lesions deemed as benign diseases on chest CT
4.Severe complication
5.Disability of cessation of anticoagulant or antiplatelet more than 2 days
6.Pregnancy
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiro Asano |
Organization
Gifu Prefectural General Medical Center
Division name
Department of Pulmonary Medicine
Zip code
Address
4-6-1 Noishiki, Gifu, 500-8717,Japan
TEL
058-246-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihiro Asano |
Organization
Gifu Prefectural General Medical Center
Division name
Department of Pulmonary Medicine
Zip code
Address
4-6-1 Noishiki, Gifu, 500-8717,Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Pulmonary Medicine, Gifu Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 16 | 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
| 2008 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 14 | Day |
Last modified on
| 2018 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002043
