UMIN ID: UMIN000056204
Registered date:20/11/2024
Randomized trial assessing the addition cryobiopsy versus transbronchial needle aspiration to ultrathin bronchoscopy for small peripheral pulmonary lesions
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Solitary pulmonary lesions |
| Date of first enrollment | 2024/11/20 |
| Target sample size | 540 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Forceps biopsy and cryobiopsy using an ultrathin bronchoscope Forceps biopsy and TBNA using an ultrathin bronchoscope |
Outcome(s)
| Primary Outcome | 1. Histopathological diagnostic yield |
|---|---|
| Secondary Outcome | 1. Safety 2. Histopathological diagnostic yield according to disease subtypes 3. Procedure times 4. Histopathological diagnostic yield according to biopsy procedures 5. Overall diagnostic yield |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Any serious, concomitant medical condition 2. Lesion located within the second ellipse from the hilum, as revealed by chest computed tomography 3. Need for a bronchoscopic procedure addressing a non-target lesion in the same setting 4. Lesion near a large vessel 5. Distance < 10 mm between the visceral pleura and central margin of the lesion 6. Prior enrollment in this trial 7. Patients who have undergone or will undergo bronchoscopy between the provision of consent and initiation of the study 8. Pregnancy 9. Inability to temporarily interrupt anticoagulant/antiplatelet agents 10. Bleeding tendency 11. Any other clinical issue identified by a study investigator |
Related Information
| Primary Sponsor | National Hospital Organization 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 460-0001 |
| Telephone | 052-951-1111 |
| masahideo@gmail.com | |
| Affiliation | National Hospital Organization 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 |
| masahideo@gmail.com | |
| Affiliation | National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine |