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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003177
Receipt No. R000003852
Scientific Title Randomized study of endobronchial ultrasound-guided transbronchial biopsy with virtual bronchoscopic navigation (EBUS-TBB-VBN) using 3.0-mm thin bronchoscope vs. 4.0-mm bronchoscope with guide sheath (GS) for diagnosis of small peripheral pulmonary lesion
Date of disclosure of the study information 2010/02/13
Last modified on 2015/02/12

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Basic information
Public title Randomized study of endobronchial ultrasound-guided transbronchial biopsy with virtual bronchoscopic navigation (EBUS-TBB-VBN) using 3.0-mm thin bronchoscope vs. 4.0-mm bronchoscope with guide sheath (GS) for diagnosis of small peripheral pulmonary lesion
Acronym Randomized study of EBUS-TBB-VBN using 3.0-mm bronchoscope vs. 4.0-mm bronchoscope with GS for peripheral pulmonary lesions
Scientific Title Randomized study of endobronchial ultrasound-guided transbronchial biopsy with virtual bronchoscopic navigation (EBUS-TBB-VBN) using 3.0-mm thin bronchoscope vs. 4.0-mm bronchoscope with guide sheath (GS) for diagnosis of small peripheral pulmonary lesion
Scientific Title:Acronym Randomized study of EBUS-TBB-VBN using 3.0-mm bronchoscope vs. 4.0-mm bronchoscope with GS for peripheral pulmonary lesions
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 accuracy of EBUS-TBB-VBN using 3.0-mm thin bronchoscope and 4.0-mm bronchoscope with GS for 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 on histology specimens
Key secondary outcomes 1. Overall diagnostic yield on the combination of culture, cytology and histology specimens
2. Diagnostic yield according to benign or malignant
3. Diagnostic yield according to lesion 20 mm> or 20 mm< in size
4. Diagnostic yield according to location
5. Visibility on EBUS
6. Diagnostic yield according to location of probe in relation to target lesion
7. Level of bronchus reached
8. Level of bronchus imaged by VBN system
9. Direct visibility of lesions with bronchoscope
10. Time of procedure
11. Frequency 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 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 EBUS-TBB-VBN using 3.0-mm thin bronchoscope
Interventions/Control_2 EBUS-TBB-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 a peripheral pulmonary lesion 30 mm< in size who need to undergo 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. Re-examination due to prior failure in this trial
5. Case with pure ground glass opacity
6. Patients needing to undergo other bronchoscopic procedures (e.g. TBNA, BAL)
7. Bleeding tendency
8. Pregnant woman
9. Other clinical difficulties in this trial
Target sample size 300

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

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@aol.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)

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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 13 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
2009 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 12 Day
Last modified on
2015 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003852

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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