Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single intervention arm - transbronchial cryobiopsy | Experimental | Patients enrolled in this single arm will have lung nodules biopsied by transbronchial cryobiopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transbronchial cryobiopsy | Diagnostic Test | When the lung nodule is visualized by thin bronchoscope (4mm) with R-EBUS, cryobiopsy is performed. If not visualized, ultrathin (3mm) bronchoscope is used. Cryobiopsy is performed with 1.1mm cryo-probe. |
| 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 cryobiopsy. 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. | 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 cryobiopsy. 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 |
|---|---|---|
| Type of bronchoscope | Type of bronchoscope used is assessed as the following scale (a. thin; b. ultrathin). | up to 1 day |
| Guide sheath use | Guide sheath use is assessed as the following scale (a. yes; b. no). |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37380091 | Derived | Kim SH, Mok J, Kim S, Yoo WH, Jo EJ, Kim MH, Lee K, Kim KU, Park HK, Lee MK, Eom JS. Clinical outcomes of transbronchial cryobiopsy using a 1.1-mm diameter cryoprobe for peripheral lung lesions - A prospective pilot study. Respir Med. 2023 Oct;217:107338. doi: 10.1016/j.rmed.2023.107338. Epub 2023 Jun 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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, transient balloon tamponade, or therapeutic bronchoscope (external diameter 6mm); 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). | up to 1 week |
| up to 1 day |
| 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). | up to 1 day |
| Procedure time in minutes and seconds | The time spent in procedure begins with the insertion of bronchoscope into vocal cord and ends with removal of bronchoscope from vocal cord. | up to 1 day |
| Diameter of cryoprobe | Diameter of cryoprobe use is assessed as the following scale (a. 1.1mm; b. 1.7mm). | up to 1 day |
| Number of biopsy | The number of biopsy samples is assessed. | up to 1 day |
| Freezing time of cryoprobe in seconds | The freezing time of cryoprobe for sampling the lesions is assessed in seconds. | up to 1 day |
| Biopsy size in millimeter | Size of biopsy tissue is assessed by pathologist for maximum and minimum diameter in millimeter. | up to 1 month |