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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024305
Receipt No. R000027994
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)
Date of disclosure of the study information 2016/10/06
Last modified on 2016/10/05

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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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 06 Day
Last follow-up date
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
2016 Year 10 Month 05 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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