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

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

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.

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.

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