UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001710
Receipt No. R000002043
Scientific Title 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
Date of disclosure of the study information 2009/02/16
Last modified on 2018/02/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym Randomized trial of transbronchial biopsy using EBUS-GS and VBN or X-ray fluoroscopy for pulmonary peripheral lesions
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Fumihiro Asano
Organization Gifu Prefectural General Medical Center
Division name Department of Pulmonary Medicine
Zip code
Address 4-6-1 Noishiki, Gifu, 500-8717,Japan
TEL 058-246-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiro Asano
Organization Gifu Prefectural General Medical Center
Division name Department of Pulmonary Medicine
Zip code
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)

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
2009 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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
2008 Year 11 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.