UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002883 |
|---|---|
| Receipt number | 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 22:17:47 |
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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
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
masahideo@aol.com
Sponsor or person
Institute
Nagoya Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003518
