UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005757 |
|---|---|
| Receipt number | R000006805 |
| Scientific Title | Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope |
| Date of disclosure of the study information | 2011/06/11 |
| Last modified on | 2014/06/11 09:42:17 |
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Basic information
Public title
Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope
Acronym
Randomized study of EBUS-TBNA versus TEBUS-FNA
Scientific Title
Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope
Scientific Title:Acronym
Randomized study of EBUS-TBNA versus TEBUS-FNA
Region
| Japan |
Condition
Condition
Hilar/mediastinal lesions
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the tolerance, accuracy and safety of EBUS-TBNA versus TEBUS-FNA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Patient comfort with EBUS-TBNA vs. TEBUS-FNA assessed by visual analog scale
Key secondary outcomes
1. Anxiety, satisfaction, coughing, vomiting, pain, dyspnea, willing to repeat procedure
2. Time of procedure
3. Diagnostic yield
4. Frequency of adverse effects
5. Oxygen desaturation
6. Doses of a sedative and an anesthetic
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EBUS-TBNA
Interventions/Control_2
TEBUS-FNA
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 lesions 10 mm or greater in short-axis diameter on CT adjoining both esophagus and trachea/bronchus, who need to undergo diagnostic bronchoscopy for the decision of management
2. 20 years old or more
3. Informed consent
Key exclusion criteria
1. Patients with lesions proven pathologically
2. Patients for mediastinal lymph node staging
3. Patients needing to undergo other bronchoscopic procedures (e.g. TBB, BAL, brushing)
4. Serious concomitant medical illness
5. Bleeding tendency
6. Pregnant woman
7. Other clinical difficulties in this study
Target sample size
110
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
| 2011 | Year | 06 | Month | 11 | 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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | 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
| 2011 | Year | 06 | Month | 10 | Day |
Last modified on
| 2014 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006805
