EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

Primary Objective:

• To evaluate the utility of transbronchial mediastinal cryobiopsy on its ability to improve the likelihood of acquiring tissue sufficient for next-generation sequencing (NGS).

Safety Endpoints:

• Pneumothorax within 7 days of procedure
• Moderate bleeding defined as controlled with bronchoscope, saline, or epinephrine
• Serious bleeding is defined as uncontrolled, leading to respiratory failure, need for transfusion, or cardiovascular instability
• Respiratory failure is defined as a new oxygen requirement or escalation in oxygen delivery within 7 days of procedure
• Unplanned hospitalization related to the procedure within 7 days of procedure
• Death

Exploratory Endpoints:

• The proportion of samples adequate for NGS testing
• The proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining
• Proportion of samples that are adequate for complete NGS library sequencing
• Estimated total number of tumor cells per H&E-stained slide
• Histological disease subtyping

Inclusion criteria

• Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS
• Malignant cells present on rapid on-site cytological evaluation (ROSE)

Exclusion criteria

• Patient is known to be less than 18 years old
• Patient is known to be pregnant
• Patient is known to be a prisoner
• Operator deems lesion is not safe to biopsy