UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Virtual bronchoscopic navigation as an aid to CT-guided transbronchial biopsy improves the diagnostic yield for small peripheral pulmonary lesions
Title of the study (Brief title)	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	Masanori Yasuo
Organization	Shinshu University School of Medicine
Division name	The First Department of Internal Medicine
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	Masanori Yasuo
Organization	Shinshu University School of Medicine
Division name	The First Department of Internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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)).
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