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

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

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050604

Enrollment

100

Registered

2023-03-17

Start date

2023-03-23

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 under suspicion of malignancy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients will undergo cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope for assessment of peripheral pulmonary lesions under suspicion of malignancy as indicated by chest computed tomography 2. 20 years old or more 3. Provision of written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMasahide Oki

National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine

masahideo@gmail.com052-951-1111

Outcome results