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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016062
Receipt No. R000018666
Scientific Title Utility of rapid on-site cytological evaluation during Endobrohchial ultrasound-guided transbronchial needle aspiration
Date of disclosure of the study information 2015/01/15
Last modified on 2017/07/28

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Basic information
Public title Utility of rapid on-site cytological evaluation during Endobrohchial ultrasound-guided transbronchial needle aspiration
Acronym Utility of ROSE during EBUS-TBNA
Scientific Title Utility of rapid on-site cytological evaluation during Endobrohchial ultrasound-guided transbronchial needle aspiration
Scientific Title:Acronym Utility of ROSE during EBUS-TBNA
Region
Japan

Condition
Condition diseases causeing hilar and mediastinal lymphadenopathy (malignancy, sarcodosis, etc)
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to explore the utility of Rapid on-site cytological evaluation (ROSE) during endobronchial ultrasound-guided needle aspiration (EBUS-TBNA)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnostic yields
Key secondary outcomes the length of the examination for EBUS-TBNA, the number of needle aspirations per patient, complications, and additional examinations needed

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who had undergone EBUS-TBNA for the diagnosis of mediastinal and/or hilar lymphadenopathy
Key exclusion criteria none
Target sample size 51

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mari Yamasue
Organization Oita university faculty of medicine
Division name Department of respiratory medicine and infectious diseases
Zip code
Address Hasama-machi Idaigaoka 1-1, Yufu-city, Oita, Japan
TEL 097-586-5804
Email sai-mari@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mari Yamasue
Organization Oita university faculty of medicine
Division name Department of respiratory medicine and infectious diseases
Zip code
Address Hasama-machi Idaigaoka 1-1, Yufu-city, Oita, Japan
TEL 097-586-5804
Homepage URL
Email sai-mari@oita-u.ac.jp

Sponsor
Institute Oita university faculty of medicine, Department of respiratory medicine and infectious diseases
Institute
Department

Funding Source
Organization Oita university faculty of medicine, Department of respiratory medicine and infectious diseases
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 大分大学医学部附属病院 呼吸器内科

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 15 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
2015 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a retrospective analysis of patients who had undergone EBUS-TBNA for the diagnosis of mediastinal and (or) hilar lymphadenopathy between January 2012 and November 2014. We compare the following points between the groups of patients who underwent EBUS-TBNA with or without ROSE.

Management information
Registered date
2014 Year 12 Month 26 Day
Last modified on
2017 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018666

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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