UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000507
Receipt No. R000000615
Scientific Title Utility of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in diagnosis of sarcoidosis; comparison with transbronchial lung biopsy (TBLB)
Date of disclosure of the study information 2006/11/01
Last modified on 2013/01/02

* 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 Utility of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in diagnosis of sarcoidosis; comparison with transbronchial lung biopsy (TBLB)
Acronym EBUS-TBNA in the diagnosis of sarcoidosis
Scientific Title Utility of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in diagnosis of sarcoidosis; comparison with transbronchial lung biopsy (TBLB)
Scientific Title:Acronym EBUS-TBNA in the diagnosis of sarcoidosis
Region
Japan

Condition
Condition Sarcoidosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the diagnostic utility of EBUS-TBNA and TBLB in patients with suspected stage I/II sarcoidosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Sensitivity of pathological diagnosis of sarcoidosis
Key secondary outcomes Frequency of adverse effects

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. Patients with suspected stage I/II sarcoidosis based on clinicoradiological pictures who need to undergo diagnostic bronchoscopy 2. Hilar-mediastinal nodes 10 mm or greater in short-axis diameter on chest computed tomography 3. 20 years and above 4. Informed consent
Key exclusion criteria 1. Serious concomitant medical illness 2. Obvious bleeding tendency 3. Pregnancy 4. Other clinical difficulties in this study
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahide Oki
Organization Nagoya Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL 052-951-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahide Oki
Organization Nagoya Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL 052-951-1111
Homepage URL
Email Masahideo@aol.com

Sponsor
Institute Nagoya Medical Center
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
2006 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://jtcs.ctsnetjournals.org/cgi/content/abstract/143/6/1324
Number of participants that the trial has enrolled
Results
Of the 62 patients enrolled, 54 were given a final diagnosis of sarcoidosis. The diagnostic yield of EBUS-TBNA and TBLB for sarcoidois by showing noncaseating epithelioid cell granuloma was 94% (stage I, 97%; stage II, 88%) and 37% (stage I, 31%; stage II, 50%), respectively. The difference was statistically significant (p<0.001). One pneumothorax and 3 moderate bleeding cases (7%) resulted from TBLB, and 1 severe cough case (2%) from EBUS-TBNA.
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
2006 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The sensitivity of EBUS-TBNA and TBLB for pathological diagnosis of sarcoidosis is to be observed.

Management information
Registered date
2006 Year 10 Month 30 Day
Last modified on
2013 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000615

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.