Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions

Diagnostic yield

Diagnostic yield is defined as the proportion of procedures that results in acquisition of lesional tissue. Lesional tissue is defined by the presence of histopathological findings that readily explain the presence of a pulmonary lesion. The following common histopathological findings are pre-specified as lesional: i. Malignant ii. "Specific benign" findings accounting for the presence of a PPL * organizing pneumonia * purulence * granulomatous inflammation * hamartoma * amyloidoma Procedures with non-specific inflammation, normal tissue, atypia not diagnostic of malignancy, or where no biopsy is obtained due to navigation failure, complication, or equipment failure are non-diagnostic. Only guided bronchoscopy biopsies from the first target lesion are included; non-malignant samples are reviewed by a blinded panel.

Radiation Exposure During Study Bronchoscopy

Radiation exposure is defined as the radiation dose delivered to the patient during the study bronchoscopy, recorded as the dose area product (mGy·cm²). Only radiation directly associated with the index bronchoscopy procedure will be included.

Duration of Bronchoscopy

Duration of bronchoscopy is defined as the time (in minutes) from insertion of the robotic catheter into the endotracheal tube to removal of the catheter from the endotracheal tube after completion of the procedure.

Need for Additional Diagnostic Procedures

This outcome is defined as any additional diagnostic procedure performed to evaluate the lung lesion of interest after the index bronchoscopy. Procedures include repeat bronchoscopy, transthoracic needle biopsy, or surgical lung biopsy.

Diagnostic Accuracy at 12 Months Post-Bronchoscopy

Diagnostic accuracy is defined as the ability of the index bronchoscopy procedure to correctly identify the pathology of the target lung nodule, as confirmed by clinical follow-up, additional diagnostic procedures, or surgical pathology within 12 months after the biopsy. Both malignant and specific benign diagnoses will be included in the assessment of accuracy.

Specimen Suitability for Molecular Analysis

This outcome assesses whether tissue obtained during the index bronchoscopy procedure is adequate for molecular analysis when clinically indicated. Specimen suitability will be determined based on quantity, quality, and integrity of the tissue for intended molecular testing.