UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized study of endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: TBB with 3.0-mm ultrathin bronchoscope vs. TBB followed by transbronchial needle aspiration (TBNA) with 4.0-mm bronchoscope
Title of the study (Brief title)	Randomized study of EBUS-TBB-VBN with 3.0-mm bronchoscope vs. EBUS-TBB/TBNA-VBN with 4.0-mm bronchoscope
Region	Japan

Condition
Condition	Benign or malignant pulmonary lesions
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the diagnostic yield of EBUS-TBB-VBN using 3.0-mm ultrathin bronchoscope and EBUS-TBB/TBNA-VBN using 4.0-mm bronchoscope for the diagnosis of small peripheral pulmonary lesions
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	1. Diagnostic yield
Key secondary outcomes	1. Diagnostic yield on histology specimens 2. Diagnostic yield: benign or malignant 3. Diagnostic yield according to lesion size: 20 mm> or 20 mm< 4. Diagnostic yield according to location 5. Visibility by EBUS 6. Diagnostic yield according to location of probe in relation to target lesion 7. Diagnostic yield according to procedures (TBB, TBNA, washing) 8. Level of bronchus reached 9. Level of bronchus imaged by VBN system 10. Direct visibility of lesions with bronchoscope 11. Time for examination procedure 12. Incidence of adverse effects

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	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	EBUS-TBB-VBN using 3.0-mm ultrathin bronchoscope
Interventions/Control_2	EBUS-TBB/TBNA-VBN using 4.0-mm bronchoscope
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. Patients with peripheral pulmonary lesion 30 mm<= in size requiring diagnostic bronchoscopy 2. 20 years old or more 3. Informed consent
Key exclusion criteria	1. Case with serious concomitant medical illness 2. Central pulmonary lesions 3. Diffuse pulmonary lesions 4. Prior failure in this trial 5. Case with pure ground glass opacity 6. Patients requiring other bronchoscopic procedures (e.g. EBUS-TBNA, BAL) 7. Bleeding tendency 8. Pregnant woman 9. Other presumed difficulties for patients in this trial
Target sample size	360

Research contact person
Name of lead principal investigator	Hideo Saka
Organization	Nagoya Medical Center
Division name	Department of Respiratory Medicine
Address	4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL	052-951-1111
Email

Public contact
Name of contact person	Masahide Oki
Organization	Nagoya Medical Center
Division name	Department of Respiratory Medicine
Address	4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL	052-951-1111
Homepage URL
Email	masahideo@gmail.com

Sponsor
Institute	Nagoya Medical Center
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	国立病院機構名古屋医療センター (愛知県) 岐阜総合医療センター (岐阜県)

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 23 Day
Anticipated trial start date	2013 Year 02 Month 28 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 02 Month 27 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011869