UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of rapid on-site cytological evaluation during Endobrohchial ultrasound-guided transbronchial needle aspiration
Title of the study (Brief title)	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	Mari Yamasue
Organization	Oita university faculty of medicine
Division name	Department of respiratory medicine and infectious diseases
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	Mari Yamasue
Organization	Oita university faculty of medicine
Division name	Department of respiratory medicine and infectious diseases
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018666