Status:
COMPLETED
Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions
Lead Sponsor:
Pusan National University Hospital
Collaborating Sponsors:
Erbe-med
Conditions:
Lung Nodule
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 n...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
- Age ≥ 18
- Written informed consent after participant's information
Exclusion
- Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
- Pure GGO lesion
- Patients at increased risk of bleeding
- Cannot stop agents such as antiplatelet agent or anticoagulant therapy
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06123312
Start Date
November 1 2023
End Date
October 4 2024
Last Update
December 27 2024
Active Locations (1)
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1
Pusan National University hospital
Busan, South Korea, 49241