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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001985
Receipt No. R000002295
Scientific Title Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction
Date of disclosure of the study information 2009/05/25
Last modified on 2010/08/02

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Basic information
Public title Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction
Acronym Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction
Scientific Title Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction
Scientific Title:Acronym Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Endobronchial ultrasonography (EBUS) has been used in diagnosing peripheral lung cancer and has allowed for higher rates of peripheral lung cancer diagnosis, but few studies have reported that fluoroscopy time is shorted by the use of EBUS. Therefore, this study is a
retrospective study on shorting fluoroscopy time using EBUS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after EBUS introduction
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Discussion of the rate of diagnosis and fluoroscopy time in lung cancer in groups before EBUS introduction during twenty-one months
Interventions/Control_2 Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups after EBUS introduction during twenty-one months
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases diagnosed as lung cancer by bronchoscope

Key exclusion criteria Cases judged that method of bronchoscope is difficult



Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitsugu Fujita
Organization St Marianna University school of Medicine
Division name Division of Respiratory and Infectious Diseases Department of Internal Medicine
Zip code
Address 2-16-1 Sugao Miyamaeku Kawasaki Kanagawa Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization St Marianna University school of Medicine
Division name Division of Respiratory and Infectious Diseases Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute St Marianna University school of Medicine
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
2009 Year 05 Month 25 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 01 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2014 Year 12 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 05 Month 19 Day
Last modified on
2010 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002295

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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