Unique ID issued by UMIN | UMIN000003177 |
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Receipt number | R000003852 |
Scientific Title | Randomized study of endobronchial ultrasound-guided transbronchial biopsy with virtual bronchoscopic navigation (EBUS-TBB-VBN) using 3.0-mm thin bronchoscope vs. 4.0-mm bronchoscope with guide sheath (GS) for diagnosis of small peripheral pulmonary lesion |
Date of disclosure of the study information | 2010/02/13 |
Last modified on | 2015/02/12 14:01:12 |
Randomized study of endobronchial ultrasound-guided transbronchial biopsy with virtual bronchoscopic navigation (EBUS-TBB-VBN) using 3.0-mm thin bronchoscope vs. 4.0-mm bronchoscope with guide sheath (GS) for diagnosis of small peripheral pulmonary lesion
Randomized study of EBUS-TBB-VBN using 3.0-mm bronchoscope vs. 4.0-mm bronchoscope with GS for peripheral pulmonary lesions
Randomized study of endobronchial ultrasound-guided transbronchial biopsy with virtual bronchoscopic navigation (EBUS-TBB-VBN) using 3.0-mm thin bronchoscope vs. 4.0-mm bronchoscope with guide sheath (GS) for diagnosis of small peripheral pulmonary lesion
Randomized study of EBUS-TBB-VBN using 3.0-mm bronchoscope vs. 4.0-mm bronchoscope with GS for peripheral pulmonary lesions
Japan |
Benign or malignant pulmonary lesions
Pneumology |
Malignancy
NO
To compare the diagnostic accuracy of EBUS-TBB-VBN using 3.0-mm thin bronchoscope and 4.0-mm bronchoscope with GS for diagnosis of small peripheral pulmonary lesions
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
1. Diagnostic yield on histology specimens
1. Overall diagnostic yield on the combination of culture, cytology and histology specimens
2. Diagnostic yield according to benign or malignant
3. Diagnostic yield according to lesion 20 mm> or 20 mm< in size
4. Diagnostic yield according to location
5. Visibility on EBUS
6. Diagnostic yield according to location of probe in relation to target lesion
7. Level of bronchus reached
8. Level of bronchus imaged by VBN system
9. Direct visibility of lesions with bronchoscope
10. Time of procedure
11. Frequency of adverse effects
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as a block.
YES
Central registration
2
Diagnosis
Device,equipment |
EBUS-TBB-VBN using 3.0-mm thin bronchoscope
EBUS-TBB-VBN using 4.0-mm bronchoscope
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with a peripheral pulmonary lesion 30 mm< in size who need to undergo diagnostic bronchoscopy
2. 20 years old or more
3. Informed consent
1. Case with serious concomitant medical illness
2. Central pulmonary lesions
3. Diffuse pulmonary lesions
4. Re-examination due to prior failure in this trial
5. Case with pure ground glass opacity
6. Patients needing to undergo other bronchoscopic procedures (e.g. TBNA, BAL)
7. Bleeding tendency
8. Pregnant woman
9. Other clinical difficulties in this trial
300
1st name | |
Middle name | |
Last name | Masahide Oki |
Nagoya Medical Center
Department of Respiratory Medicine
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
052-951-1111
1st name | |
Middle name | |
Last name | Masahide Oki |
Nagoya Medical Center
Department of Respiratory Medicine
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
052-951-1111
masahideo@aol.com
Nagoya Medical Center
None
Self funding
NO
2010 | Year | 02 | Month | 13 | Day |
Unpublished
Completed
2009 | Year | 10 | Month | 09 | Day |
2010 | Year | 02 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2010 | Year | 02 | Month | 12 | Day |
2015 | Year | 02 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003852
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