UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000569 |
|---|---|
| Receipt number | R000000687 |
| Scientific Title | Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy using X-ray fluoroscopy and endobronchial ultrasonography with guide-sheath (BUS-GS) for pulmonary peripheral small lesions |
| Date of disclosure of the study information | 2006/12/29 |
| Last modified on | 2008/01/04 21:25:51 |
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Basic information
Public title
Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy using X-ray fluoroscopy and endobronchial ultrasonography with guide-sheath (BUS-GS) for pulmonary peripheral small lesions
Acronym
Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy for pulmonary peripheral small lesions
Scientific Title
Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy using X-ray fluoroscopy and endobronchial ultrasonography with guide-sheath (BUS-GS) for pulmonary peripheral small lesions
Scientific Title:Acronym
Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy for pulmonary peripheral small lesions
Region
| Japan |
Condition
Condition
pulmonary peripheral small lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of navigation by virtual bronchoscopy in transbronchial biopsy using X-ray fluoroscopy and endobronchial ultrasonography with guide-sheath (BUS-GS) for pulmonary peripheral small lesions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
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)Difference between bronchi by virtual bronchoscopy and actual bronchi
6)Bronchial generation inserted by bronchoscopy
7)Complication
8)Patient suffering by bronchoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
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
Without navigation by virtual bronchoscopy
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.Pulmonary peripheral small lesions of ≤ 20 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
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiro Asano/Koichi Yamazaki |
Organization
Gifu Prefectural Hospital / Hokkaido University School of Medicine
Division name
Department of Respiratory Medicine / First Department of Medicine
Zip code
Address
Noisshiki 4-6-1, Gifu 500-8717, Japan / North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL
011-706-5911
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Yamazaki |
Organization
Hokkaido University School of Medicine
Division name
First Department of Medicine
Zip code
Address
North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL
011-706-5911
Homepage URL
kyamazak@med.hokudai.ac.jp
Sponsor or person
Institute
First Department of Medicine
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
| 2006 | Year | 12 | Month | 29 | 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
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
| 2006 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 29 | Day |
Last modified on
| 2008 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000687
