Lung Nodule
Conditions
Keywords
Radial Probe Endobronchial Ultrasound, Pulmonary Nodule, Forceps Biopsy, Needle Aspiration, Cryobiopsy
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 novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with peripheral pulmonary nodules.
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 in patients with peripheral pulmonary nodules.
Interventions
DIAGNOSTIC_TESTTri-modality biopsy
When the lung nodule is visualized by ultrathin bronchoscope (3mm) with RP-EBUS, Tri-modality biopsy is performed.
Sponsors
Pusan National University Hospital
Erbe-med
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield based on pathologic diagnosis | Time Frame: up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield based on clinical diagnosis | Time Frame: up to 6 months | 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. |
| Adverse events | Time Frame: up to 1 week | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of forceps biopsy | Time Frame: up to 1 day | The number of forceps biopsy samples is assessed. |
| Number of needle aspiration | Time Frame: up to 1 day | The number of needle aspiration samples is assessed. |
| Radial endobronchial ultrasound probe orientation | Time Frame: up to 1 day | Lesion orientation regarding radial endobronchial ultrasound probe is assessed as the following scale (a. within, concentric; b. within, eccentric; c. adjacent; d. invisible). |
| Biopsy size in millimeter | Time Frame: up to 1 month | Size of biopsy tissue is assessed by pathologist for maximum and minimum diameter in millimeter. |
| Freezing time of cryoprobe in seconds | Time Frame: up to 1 day | The freezing time of cryoprobe for sampling the lesions is assessed in seconds. |
| Procedure time in minutes and seconds | Time Frame: up to 1 day | The time spent in procedure begins with the insertion of bronchoscope into vocal cord and ends with removal of bronchoscope from vocal cord. |
| Diameter of cryoprobe | Time Frame: up to 1 day | Diameter of cryoprobe use is assessed as the following scale (a. 1.1mm; b. 1.7mm). |
Countries
South Korea
Outcome results
None listed