Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study

Pusan National University

Status

Completed

Conditions

Lung Nodule

Treatments

Diagnostic Test: Transbronchial cryobiopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT05046093

2105-045-103

Details and patient eligibility

About

As the former radial endobronchial ultrasound (R-EBUS) guided transbronchial forcep biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique, transbronchial cryobiopsy, in patients with peripheral pulmonary nodules.

Full description

This is a prospective, single arm, open label trial to assess the diagnostic accuracy and safety of the transbronchial cryobiopsy in patients with peripheral pulmonary nodule using a 1.1mm cryoprobe, combined with bronchoscope (with/without guide sheath), R-EBUS, virtual bronchoscopy navigation, and fluoroscopy.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
Age ≥ 18
Written informed consent after participant's information

Exclusion criteria

Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
Pure GGO lesion
Patients at increased risk of bleeding
1. Cannot stop agents such as antiplatelet agent or anticoagulant therapy
2. Coagulopathy: Thrombocytopenia (< 100,000/mm3) or prolonged PT (INR > 1.5)
Patient with existing or risk of pulmonary and cardiovascular decompensation
Intolerance to sedation
Vulnerable groups such as pregnant woman, breast feeding, etc.
Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility