A Prospective Study on the Safety and Efficacy of Additional Ultrathin Cryobiopsy to ROSE-TIC Negative Cases of Forceps Biopsy in Peripheral Pulmonary Lesions

A prospective study on the safety and efficacy of additional cryobiopsy using an ultrathin cryoprobe to ROSE-TIC negative of forceps biopsy - A prospective study on the safety and efficacy of additional cryobiopsy using an ultrathin cryoprobe to ROSE negative of forceps biopsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052642

Enrollment

Registered

2023-11-01

Start date

2023-11-01

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 which is suspected malignancy

Interventions

ROSE-TIC positive, group FB ROSE-TIC negative group, FB+CB

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 medical condition to procedure bronchoscopy 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. Pregnance 8. The inability to temporarily interrupt anticoagulant/antiplatelet agents 9. A bleeding tendency

Design outcomes

Primary

Measure	Time frame
Safety (Bleeding)	—

Secondary

Measure	Time frame
Pathological diagnosis yield Procedure time Sample size of forceps biopsy and cryobiopsy Accuracy of of rapid on-site cytologic evaluation touch imprint cytology	—

Countries

Japan

Contacts

Public ContactYuki Takigawa

National Organazation Hospital Okayama Medical Center Department of Respiratory Medicine

tacky1024@gmail.com086-294-9911

Outcome results

None listed

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