UMIN ID: UMIN000000696
Registered date:30/04/2007
Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) using 3.4-mm thin bronchoscope vs. EBUS with guide sheath (GS)-guided TBB using 4.0-mm bronchoscope for diagnosis of peripheral pulmonary lesions
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Benign or malignant pulmonary lesions |
| Date of first enrollment | 2007/04/01 |
| Target sample size | 260 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | EBUS-guided TBB using 3.4-mm thin bronchoscope EBUS-GS-guided TBB using 4.0-mm bronchoscope |
Outcome(s)
| Primary Outcome | Diagnostic yield; according to lesion size, location, benign or malignant |
|---|---|
| Secondary Outcome | 1.Frequency of adverse effects 2.Level of bronchus reached 3.Visibility on EBUS 4.Direct visibility of lesions with bronchoscope 5.Time of procedure |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 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. Patients who need to undergo other bronchoscopic procedure (e.g. TBNA, BAL) 6. Bleeding tendency 7. Pregnant woman 8. Other clinical difficulties in this trial |
Related Information
| Primary Sponsor | Nagoya Medical Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masahide Oki |
| Address | 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan Japan |
| Telephone | 052-951-1111 |
| Affiliation | Nagoya Medical Center Department of Respiratory Medicine |
| scientific contact | |
| Name | Masahide Oki |
| Address | 4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan Japan |
| Telephone | 052-951-1111 |
| Affiliation | Nagoya Medical Center Department of Respiratory Medicine |