A prospective study on the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to assess peripheral pulmonary lesions

UMIN ID: UMIN000050604

Registered date:17/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Peripheral pulmonary lesions under suspicion of malignancy
• Date of first enrollment: 2023/03/23
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 1. Safety (bleeding-related)
• Secondary Outcome: 1. Safety (other than bleeding-related) 2. Histological diagnostic yield 3. Procedure duration 4. Specimen size 5. Sampling success in terms of the freezing time 6. Biomarker test success rate

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 one-third of the hilar ellipse as revealed by chest computed tomography 3. The need for a bronchoscopic procedure exploring a non-target lesion in the same setting 4. A lesion near a large vessel 5. A distance < 10 mm between the visceral pleura and the central margin of the lesion 6. Prior enrolment in the trial 7. Patients for whom a therapeutic bronchoscope and a 1.1-mm cryoprobe were not used 8. Pregnancy 9. The inability to temporarily interrupt anticoagulant/antiplatelet agents 10. A bleeding tendency

Related Information

• Primary Sponsor: National Hospital Organization Nagoya Medical Center
• Source(s) of Monetary Support: self-funding