UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032484 |
|---|---|
| Receipt number | R000037044 |
| Scientific Title | Virtual bronchoscopic navigation as an aid to CT-guided transbronchial biopsy improves the diagnostic yield for small peripheral pulmonary lesions |
| Date of disclosure of the study information | 2018/05/08 |
| Last modified on | 2018/05/07 09:48:27 |
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Basic information
Public title
Virtual bronchoscopic navigation as an aid to CT-guided transbronchial biopsy improves the diagnostic yield for small peripheral pulmonary lesions
Acronym
Diagnostic yield with VBN and CT-TBB
Scientific Title
Virtual bronchoscopic navigation as an aid to CT-guided transbronchial biopsy improves the diagnostic yield for small peripheral pulmonary lesions
Scientific Title:Acronym
Diagnostic yield with VBN and CT-TBB
Region
| Japan |
Condition
Condition
Lung Cancer (including suspect of lung cancer)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To combine CT-guided transbronchial biopsy (CT-TBB) and VBN might improve the diagnostic yield for small PPLs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improving diagnostic yield.
Key secondary outcomes
CT-dose index
Examination time (Whole procedure time, times at which the first CT scan, and first biopsy)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional CT-guided transbronchial biopsy with or without virtual bronchoscopic navigation (VBN)
Interventions/Control_2
Using VBN is during procedure only.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with small PPLs (20 mm in diameter) were collected consecutively in Shinshu University Hospital from November 2011 to November 2014.
The definition of PPLs are generally considered as lesions in the peripheral one-third of the lung. The selection criteria for PPL included PPLs that were invisible or unlikely to be detected by X-ray fluoroscopy.
Key exclusion criteria
Negative CT-bronchus sign.
No complete data (e.g. no procedure time)
Lesion size was bigger than 20mm.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Yasuo |
Organization
Shinshu University School of Medicine
Division name
The First Department of Internal Medicine
Zip code
Address
3-1-1 Asahi Matsumoto, Nagano 390-8621, Japan
TEL
0263-37-2631
yasumasa@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Yasuo |
Organization
Shinshu University School of Medicine
Division name
The First Department of Internal Medicine
Zip code
Address
3-1-1 Asahi Matsumoto, Nagano 390-8621, Japan
TEL
0263-37-2631
Homepage URL
yasumasa@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self finding
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
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
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The diagnostic yield for small PPLs was significantly higher in the VBN+ group versus (vs.) VBN- group (84% vs. 58%, respectively (p=0.013)).
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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 07 | Day |
Last modified on
| 2018 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037044
| 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 |
