Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions

Pusan National University

Status

Enrolling

Conditions

Lung Nodule

Treatments

Diagnostic Test: Tri-modality biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT06123312

2310-020-132

Details and patient eligibility

About

As the former radial probe endobronchial ultrasound (RP-EBUS) guided transbronchial forceps biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with peripheral pulmonary nodules.

Full description

This is a prospective, single-arm, open-label trial designed to assess the diagnostic accuracy and safety of the Tri-modality (forceps biopsy, needle aspiration, and transbronchial cryobiopsy) biopsy in patients with peripheral pulmonary nodules.

Enrollment

50 estimated 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