UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001910
Receipt No. R000002323
Scientific Title Comparison of 21- and 22-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration of mediastinal and hilar lymph nodes
Date of disclosure of the study information 2009/04/27
Last modified on 2009/04/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of 21- and 22-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration of mediastinal and hilar lymph nodes
Acronym Comparison of 21- and 22-gauge needles for EBUS-TBNA of mediastinal and hilar lymph nodes
Scientific Title Comparison of 21- and 22-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration of mediastinal and hilar lymph nodes
Scientific Title:Acronym Comparison of 21- and 22-gauge needles for EBUS-TBNA of mediastinal and hilar lymph nodes
Region
Japan

Condition
Condition diseases with mediastinal and hilar lymph nodes
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the safety and efficacy of obtaining specimens using 21-gauge needles, comparing diagnostic yield with conventional 22-gauge needles.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety and efficacy
Key secondary outcomes

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 patients with mediastinal and hilar lymph nodes
Key exclusion criteria None
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Kurimoto
Organization St. Marianna University School of Medicine
Division name Division of Chest Surgery
Zip code
Address 2-16-1Sugao, Miyamae, Kawasaki, Kanagawa 216-8511, Japan
TEL 0449778111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization St. Marianna University School of Medicine
Division name Division of Chest Surgery
Zip code
Address
TEL 0449778111
Homepage URL
Email

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 04 Month 27 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
Date of protocol fixation
2008 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information random study

Management information
Registered date
2009 Year 04 Month 27 Day
Last modified on
2009 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002323

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.