Prospective study on the safety and efficacy of cryobiopsy through a cuffed long tracheal tube

Prospective study on the safety and efficacy of cryobiopsy through a cuffed long tracheal tube - Cryobiopsy through a cuffed long tracheal tube

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059295

Enrollment

Registered

2025-10-06

Start date

2025-10-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral pulmonary lesions suspected of malignancy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing cryobiopsy with a cuffed long tracheal tube for assessment of peripheral pulmonary lesions 2. 20 years old or more 3. Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1. Lesions with a leading bronchus inaccessible to the long tracheal tube (e.g., right apical lung lesions, left upper lobe lesions) 2. Patients in whom a long tracheal tube is not used 3. Prior enrollment in the trial 4. Any serious concomitant medical condition 5. Lesions located within one-third of the hilar ellipse on chest computed tomography 6. Requirement for a bronchoscopic procedure to explore a non-target lesion in the same session 7. Lesions adjacent to a large vessel 8. Distance of < 10 mm between the visceral pleura and the central margin of the lesion 9. Pregnancy 10. Inability to temporarily discontinue anticoagulant/antiplatelet therapy 11. Bleeding tendency

Design outcomes

Primary

Measure	Time frame
1. Safety (bleeding-related)	—

Secondary

Measure	Time frame
1. Safety (non-bleeding-related) 2. Frequency of oxygen desaturation 3. Histological diagnostic yield 4. Specimen size 5. Procedure duration	—

Countries

Japan

Contacts

Public ContactMasahide Oki

National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine

masahideo@gmail.com052-951-1111

Outcome results