Use of an ultrathin bronchoscope for cryobiopsy of small, peripheral pulmonary lesions

UMIN ID: UMIN000045477

Registered date:14/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solitary pulmonary lesions
• Date of first enrollment: 2021/10/21
• Target sample size: 330
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Forceps biopsy and cryobiopsy using an ultrathin bronchoscope
Forceps biopsy using an ultrathin bronchoscope

Outcome(s)

• Primary Outcome: 1. Histopathological diagnostic yield
• Secondary Outcome: 1. Safety 2. Histopathological diagnostic yield according to subtypes 3. Procedural times 4. Histopathological diagnostic yield according to biopsy procedure

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• 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 the 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
• Source(s) of Monetary Support: Self funding