UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized trial of transbronchial biopsy using endobronchial ultrasonography with guide sheath (EBUS-GS) and navigation by virtual bronchoscopy or X-ray fluoroscopy for pulmonary peripheral lesions
Title of the study (Brief title)	Randomized trial of transbronchial biopsy using EBUS-GS and VBN or X-ray fluoroscopy for 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 VBN can be applied instead of X-ray fluoroscopy in transbronchial biopsy using EBUS/GS for pulmonary peripheral lesions
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

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)Agreement between bronchi by virtual bronchoscopy and actual bronchi 6)Bronchial generation inserted by bronchoscopy 7)Bronchial generation observed by bronchoscopy 8)Complication 9)Pain degree subscale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
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	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.Peripheral pulmonary lesions of 30 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	140

Research contact person
Name of lead principal investigator	Fumihiro Asano
Organization	Gifu Prefectural General Medical Center
Division name	Department of Pulmonary Medicine
Address	4-6-1 Noishiki, Gifu, 500-8717,Japan
TEL	058-246-1111
Email

Public contact
Name of contact person	Fumihiro Asano
Organization	Gifu Prefectural General Medical Center
Division name	Department of Pulmonary Medicine
Address	4-6-1 Noishiki, Gifu, 500-8717,Japan
TEL
Homepage URL
Email

Sponsor
Institute	Department of Pulmonary Medicine, Gifu Prefectural General Medical Center
Institute
Department

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)

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	2009 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 11 Month 27 Day
Anticipated trial start date	2009 Year 02 Month 01 Day
Last follow-up date	2011 Year 08 Month 01 Day
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	2009 Year 02 Month 14 Day
Last modified on	2018 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002043