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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002883
Receipt No. R000003518
Scientific Title Phase II study of transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the diagnosis of sarcoidosis
Date of disclosure of the study information 2009/12/12
Last modified on 2013/02/14

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Basic information
Public title Phase II study of transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the diagnosis of sarcoidosis
Acronym TEBUS-FNA in the diagnosis of sarcoidosis
Scientific Title Phase II study of transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the diagnosis of sarcoidosis
Scientific Title:Acronym TEBUS-FNA 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 assess the diagnostic accuracy, safety and feasibility on TEBUS-FNA using an EBUS bronchoscope 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 II

Assessment
Primary outcomes 1. Sensitivity of pathological diagnosis of sarcoidosis
Key secondary outcomes 1. Time of procedure
2. Sensitivity: according to lymph node location, cytology or histology, stage I or II
3. Frequency of adverse effects
4. Feasibility

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 TEBUS-FNA in the diagnosis of sarcoidosis
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
18 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 have hilar-mediastinal nodes 10 mm or greater in short-axis diameter on CT
2. 18 years or older
3. Informed consent
Key exclusion criteria 1. Serious concomitant medical illness
2. SPO2<90% with supplemental oxygen
3. Obvious bleeding tendency
4. Pregnancy
5. Other clinical difficulties in this study
Target sample size 33

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 国立病院機構 名古屋医療センター(愛知県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.karger.com/Article/FullText/345207
Number of participants that the trial has enrolled
Results
A total of 62 lymph nodes with the mean shortest diameter of 13.6 mm were examined. Of the 33 patients enrolled, 29 were given a final diagnosis of sarcoidosis. Four of the residual patients had other diseases (1 lung cancer, 1 tuberculosis, 2 non-specific lymphadenitis). Transesophageal bronchoscopic ultrasound-guided fine needle aspiration showed noncaseating epithelioid cell granulomas in 25 of 29 patients (86%; 95% confidence interval, 73%-100%) with the final diagnosis of sarcoidosis. No complications were observed.
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 11 Month 09 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2013 Year 03 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 12 Month 11 Day
Last modified on
2013 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003518

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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