Unique ID issued by UMIN | UMIN000000509 |
---|---|
Receipt number | R000000617 |
Scientific Title | Phase II study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy using thin bronchoscope (XBF-3B260Y1) with miniature probe (XUM-S20-17R) for diagnosis of peripheral pulmonary lesions |
Date of disclosure of the study information | 2006/11/01 |
Last modified on | 2009/12/11 21:40:55 |
Phase II study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy using thin bronchoscope (XBF-3B260Y1) with miniature probe (XUM-S20-17R) for diagnosis of peripheral pulmonary lesions
EBUS-guided transbronchial biopsy using thin bronchoscope with miniature probe
Phase II study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy using thin bronchoscope (XBF-3B260Y1) with miniature probe (XUM-S20-17R) for diagnosis of peripheral pulmonary lesions
EBUS-guided transbronchial biopsy using thin bronchoscope with miniature probe
Japan |
Benign or malignant pulmonary lesions
Pneumology |
Malignancy
NO
To assess the utility of EBUS-guided transbronchial biopsy using a novel thin bronchoscope (XBF-3B260Y1) with miniature probe (XUM-S20-17R) for diagnosis of peripheral pulmonary lesions
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Diagnostic yield
1. Frequency of adverse effects 2. Level of bronchus reached 3. Visibility on EBUS 4. Direct visibility of lesions with bronchoscope 5. Optimal number of biopsies
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with a peripheral pulmonary nodule or mass who need to undergo diagnostic bronchoscopy. 2. 20 years and above 3. Informed consent
1. Serious concomitant medical illness 2. Obvious central pulmonary lesion 3. Diffuse pulmonary lesions 4. Re-examination due to prior failure in this trial 5. Obvious bleeding tendency 6. Pregnancy 7. Other clinical difficulties in this study
140
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
2006 | Year | 11 | Month | 01 | Day |
Published
http://journals.lww.com/jto/Abstract/2009/10000/Endobronchial_Ultrasound_Guided_Transbronchial.16.aspx
A total of 86 patients with suspected peripheral lesions were included in this prospective study. Twelve patients with endobronchial lesions within the segmental bronchi and 3 patients who did not return to follow-up were excluded from this analysis. Thus, a total of 71 patients with peripheral pulmonary lesions (mean size, 31.2 +- 12.7 mm) were included in the final analysis. The mean bronchus level reached with the thin bronchoscope was 4.6 generations. Diagnostic histologic specimens were obtained in 49 of 71 patients (69%: 80% for malignant lesions and 52% for benign lesions). There were no significant complications.
Completed
2006 | Year | 02 | Month | 09 | Day |
2006 | Year | 03 | Month | 01 | Day |
2008 | Year | 03 | Month | 01 | Day |
Observation of diagnostic yield of transbronchial biopsy using new thin bronchoscope with miniature EBUS probe for peripheral pulmonary lesions
2006 | Year | 10 | Month | 30 | Day |
2009 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000617