UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized trial of transbronchial diagnosis using navigation by virtual bronchoscopy and endobronchial ultrasonography and guide sheath (EBUS-GS) with or without X-ray fluoroscopy for small pulmonary peripheral lesions
Title of the study (Brief title)	Randomized trial of transbronchial diagnosis using Bf-NAVI and EBUS-GS with or without X-ray fluoroscopy for small 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 transbronchial diagnosis using Bf-NAVI and EBUS-GS without X-ray for pulmonary peripheral lesions is similar to the bronchoscopy with X-ray
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Yield (Diagnostic rate)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	without X-ray fluoroscopy
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.small peripheral pulmonary lesions of less than 30 mm , 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	Motoko Tachihara
Organization	Kobe University Hospital
Division name	Department of Respiratory Medicine
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-5660
Email	mt0318@med.kobe-u.ac.jp

Public contact
Name of contact person	Motoko Tachihara
Organization	Kobe University Hospital
Division name	Department of Respiratory Medicine
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-5660
Homepage URL
Email	mt0318@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 15 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 01 Day
Last modified on	2018 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010094