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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000569
Receipt No. R000000687
Scientific Title Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy using X-ray fluoroscopy and endobronchial ultrasonography with guide-sheath (BUS-GS) for pulmonary peripheral small lesions
Date of disclosure of the study information 2006/12/29
Last modified on 2008/01/04

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Basic information
Public title Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy using X-ray fluoroscopy and endobronchial ultrasonography with guide-sheath (BUS-GS) for pulmonary peripheral small lesions
Acronym Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy for pulmonary peripheral small lesions
Scientific Title Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy using X-ray fluoroscopy and endobronchial ultrasonography with guide-sheath (BUS-GS) for pulmonary peripheral small lesions
Scientific Title:Acronym Randomized trial of transbronchial biopsy with or without navigation by virtual bronchoscopy for pulmonary peripheral small lesions
Region
Japan

Condition
Condition pulmonary peripheral small lesions
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy of navigation by virtual bronchoscopy in transbronchial biopsy using X-ray fluoroscopy and endobronchial ultrasonography with guide-sheath (BUS-GS) for pulmonary peripheral small lesions
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

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)Difference between bronchi by virtual bronchoscopy and actual bronchi
6)Bronchial generation inserted by bronchoscopy
7)Complication
8)Patient suffering by bronchoscopy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
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 Without navigation by virtual bronchoscopy
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.Pulmonary peripheral small lesions of &#8804; 20 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 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiro Asano/Koichi Yamazaki
Organization Gifu Prefectural Hospital / Hokkaido University School of Medicine
Division name Department of Respiratory Medicine / First Department of Medicine
Zip code
Address Noisshiki 4-6-1, Gifu 500-8717, Japan / North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL 011-706-5911
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Yamazaki
Organization Hokkaido University School of Medicine
Division name First Department of Medicine
Zip code
Address North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL 011-706-5911
Homepage URL
Email kyamazak@med.hokudai.ac.jp

Sponsor
Institute First Department of Medicine
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
2006 Year 12 Month 29 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
2006 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2007 Year 09 Month 01 Day
Date of closure to data entry
2007 Year 11 Month 01 Day
Date trial data considered complete
2007 Year 11 Month 01 Day
Date analysis concluded
2008 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 12 Month 29 Day
Last modified on
2008 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000687

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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