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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009991
Receipt No. R000011699
Scientific Title Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions
Date of disclosure of the study information 2013/02/07
Last modified on 2014/05/06

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Basic information
Public title Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions
Acronym Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions
Scientific Title Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions
Scientific Title:Acronym Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions
Region
Japan

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

Objectives
Narrative objectives1 To clarify the indication of transbronchial biopsy using virtual bronchoscopic navigation combined with radial-type endobronchial ultrasonography and guide sheath in malignant peripheral pulmonary lesions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic sensitivity.
Key secondary outcomes Correlation between diagnostic sensitivity and findings of CT and FDG-PET (lesion diameter, location of lesion, CT findings, relationship between the lesions and the bronchial tree, bronchial generation of VBN, and SUVmax of FDG-PET).

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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.Small malignant peripheral pulmonary lesions of 30 mm>=
2.Not visible by bronchoscopy
3.20 or more than 20 years of age
4.Patients who underwent both CT and FDG-PET
Key exclusion criteria 1.Visible by bronchoscopy
2.Less than 20 years of age
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Umeda
Organization University of Fukui
Division name Third Department of Internal Medicine
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui 910-1193 Japan
TEL 0776-61-3111
Email umeda@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Umeda
Organization University of Fukui
Division name Third Department of Internal Medicine
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui 910-1193 Japan
TEL 0776-61-3111
Homepage URL
Email umeda@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Ishikawa Prefectural Central Hospital
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 福井大学医学部附属病院(福井県)、石川県立中央病院(石川県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S0169500214001469
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
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 19 Day
Last follow-up date
2013 Year 07 Month 31 Day
Date of closure to data entry
2013 Year 07 Month 31 Day
Date trial data considered complete
2013 Year 07 Month 31 Day
Date analysis concluded
2013 Year 07 Month 31 Day

Other
Other related information Retrospective study

Management information
Registered date
2013 Year 02 Month 07 Day
Last modified on
2014 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011699

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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