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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032484
Receipt No. 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

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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
Email 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
Email yasumasa@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037044

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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