Randomized trial assessing the addition cryobiopsy versus transbronchial needle aspiration to ultrathin bronchoscopy for small peripheral pulmonary lesions

Randomized phase 3 trial comparing the utility of adding cryobiopsy versus transbronchial needle aspiration to forceps biopsy during ultrathin bronchoscopy when diagnosing small peripheral pulmonary lesions - Cryobiopsy vs. TBNA during ultrathin bronchoscopy to diagnose small peripheral pulmonary lesions (NMC-UT-Cryo 3)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056204

Enrollment

540

Registered

2024-11-20

Start date

2024-11-20

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

Solitary pulmonary lesions

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with peripheral pulmonary lesions <= 30 mm in diameter who require a biopsy before deciding on management 2. Age >= 20 years 3. Informed consent given

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
1. Histopathological diagnostic yield	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMasahide Oki

National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine

masahideo@gmail.com052-951-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026