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

A randomized Phase 3 trial exploring the utility of addition of cryobiopsy to forceps biopsy using an ultrathin bronchoscope when diagnosing small, peripheral pulmonary lesions - A randomized trial exploring the utility of addition of cryobiopsy to forceps biopsy using an ultrathin bronchoscope when diagnosing small, peripheral pulmonary lesions (NMC-UT-Cryo 2)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045477

Enrollment

330

Registered

2021-09-14

Start date

2021-10-21

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 using an ultrathin bronchoscope

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with peripheral pulmonary lesions <= 30 mm in diameter that require biopsy prior to management decision-making 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 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

Design outcomes

Primary

Measure	Time frame
1. Histopathological diagnostic yield	—

Secondary

Measure	Time frame
1. Safety 2. Histopathological diagnostic yield according to subtypes 3. Procedural times 4. Histopathological diagnostic yield according to biopsy procedure	—

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