Lung Nodule
Conditions
Keywords
Cryobiopsy, Pulmonary nodule, Radial EBUS
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTTransbronchial cryobiopsy
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.
Sponsors
Pusan National University Hospital
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 | up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield based on clinical diagnosis | up to 6 months | 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. |
| Adverse events | 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, 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedure time in minutes and seconds | 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 | up to 1 day | Diameter of cryoprobe use is assessed as the following scale (a. 1.1mm; b. 1.7mm). |
| Type of bronchoscope | up to 1 day | Type of bronchoscope used is assessed as the following scale (a. thin; b. ultrathin). |
| Freezing time of cryoprobe in seconds | up to 1 day | The freezing time of cryoprobe for sampling the lesions is assessed in seconds. |
| Biopsy size in millimeter | up to 1 month | Size of biopsy tissue is assessed by pathologist for maximum and minimum diameter in millimeter. |
| Number of biopsy | up to 1 day | The number of biopsy samples is assessed. |
| Guide sheath use | up to 1 day | Guide sheath use is assessed as the following scale (a. yes; b. no). |
| Radial endobronchial ultrasound probe orientation | 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). |
Countries
South Korea
Outcome results
None listed