UMIN-CTR Clinical Trial

Basic information
Public title	Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: guide sheath (GS) method vs. non-guide sheath method (Non-GS)
Acronym	Comparison of GS vs. Non-GS method during EBUS-TBB
Scientific Title	Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: guide sheath (GS) method vs. non-guide sheath method (Non-GS)
Scientific Title:Acronym	Comparison of GS vs. Non-GS method during EBUS-TBB
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 with and without a GS for the diagnosis of small peripheral pulmonary lesions
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	1. Diagnostic yield of histology specimens
Key secondary outcomes	1. Overall diagnostic yield of the combination of culture, cytology, and 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 lesion location relative to the hilum: middle third ellipse or outer third ellipse 5. Diagnostic yield according to lesion location in the bronchopulmonary segment 6. Visibility with EBUS 7. Diagnostic yield according to the probe location relative to the target lesion 8. Diagnostic yield according to the presence of the air bronchus sign 9. Diagnostic yield according to lesion appearance on computed tomography (CT): solid or ground glass nodule 10. Level of bronchus reached 11. Time taken 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 with GS
Interventions/Control_2	EBUS-TBB-VBN without GS
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 a peripheral pulmonary lesion < 30 mm in size who need to undergo diagnostic bronchoscopy 2. 20 years old or older 3. Informed consent
Key exclusion criteria	1. Serious concomitant medical illness 2. Central pulmonary lesions 3. Lesion located within the inner third ellipse from the hilum on chest CT 4. Re-examination following prior failure in this trial 5. Case with pure ground glass nodule 6. Patients needing to undergo bronchoscopic procedures for non-target lesion in the same setting 7. Diffuse pulmonary lesions 8. Pregnancy 9. Bleeding tendency 10. Other clinical difficulties in this trial
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahide Oki
Organization	Nagoya Medical Center
Division name	Department of Respiratory Medicine
Zip code
Address	4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL	052-951-1111
Email	masahideo@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Masahide Oki
Organization	Nagoya Medical Center
Division name	Department of Respiratory Medicine
Zip code
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	Self-funding
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	国立病院機構名古屋医療センター (愛知県)

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2016 Year 09 Month 28 Day
Date of IRB	2016 Year 09 Month 29 Day
Anticipated trial start date	2016 Year 10 Month 06 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 05 Day
Last modified on	2021 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027994