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| Name | Class |
|---|---|
| Erbe-med | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single intervention arm: Tri-modality biopsy | Experimental | Patients enrolled in this single arm will have lung nodules biopsied by Tri-modality (forceps biopsy, needle aspiration, and cryobiopsy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tri-modality biopsy | Diagnostic Test | When the lung nodule is visualized by ultrathin bronchoscope (3mm) with RP-EBUS, Tri-modality biopsy is performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield based on pathologic diagnosis | Diagnostic yield based on pathologic diagnosis is defined as percentage of definitive pathological diagnosis by transbronchial Tri-modality biopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure. | Time Frame: up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield based on clinical diagnosis | Diagnostic yield based on clinical diagnosis is defined as percentage of pathological diagnosis with suspicious results by transbronchial Tri-modality biopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Radial endobronchial ultrasound probe orientation | Lesion orientation regarding radial endobronchial ultrasound probe is assessed as the following scale (a. within, concentric; b. within, eccentric; c. adjacent; d. invisible). | Time Frame: up to 1 day |
| Procedure time in minutes and seconds |
Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Jung Seop Eom, MD, PhD | Pusan National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University hospital | Busan | 49241 | South Korea |
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| Time Frame: up to 6 months |
| Adverse events | Occurrence of bleeding, pneumothorax, and infection events (during the procedure and within 1 week after the intervention). Bleeding will be assessed as the following scale (a. mild = self-limiting bleeding, manageable with suction alone and without the need for any specific intervention; b. moderate = use of any additional intervention such as instillation of ice-cold saline or vasoconstrictive drugs, or transient balloon tamponade, ; c. severe = additional prolonged monitoring or intensive care therapy after the procedure or if the bleeding was fatal). Pneumothorax will be assessed as the following scale (a. pneumothorax not requiring chest tube insertion; b. pneumothorax requiring chest tube insertion). | Time Frame: up to 1 week |
The time spent in procedure begins with the insertion of bronchoscope into vocal cord and ends with removal of bronchoscope from vocal cord. |
| Time Frame: up to 1 day |
| Diameter of cryoprobe | Diameter of cryoprobe use is assessed as the following scale (a. 1.1mm; b. 1.7mm). | Time Frame: up to 1 day |
| Number of forceps biopsy | The number of forceps biopsy samples is assessed. | Time Frame: up to 1 day |
| Number of needle aspiration | The number of needle aspiration samples is assessed. | Time Frame: up to 1 day |
| Freezing time of cryoprobe in seconds | The freezing time of cryoprobe for sampling the lesions is assessed in seconds. | Time Frame: up to 1 day |
| Biopsy size in millimeter | Size of biopsy tissue is assessed by pathologist for maximum and minimum diameter in millimeter. | Time Frame: up to 1 month |