Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study

Conditions
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Lung Nodule

Intervention / Treatment
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* Diagnostic Test: Transbronchial cryobiopsy


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single intervention arm - transbronchial cryobiopsy<br>Patients enrolled in this single arm will have lung nodules biopsied by transbronchial cryobiopsy. | Diagnostic Test: Transbronchial cryobiopsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryobiopsy, Pulmonary nodule, Radial EBUS