The PRECIsE study: a prospective, multicenter study of shape-sensing robotic-assisted bronchoscopy with 2 years of follow-up.

Abstract

Rationale: Guidelines recommend nonsurgical biopsy for indeterminate pulmonary lesions >8 mm. Shape-sensing robotic-assisted bronchoscopy (ssRAB) is growing in use to biopsy small pulmonary nodules; however, current literature is limited to single-center studies with limited follow-up.

Objectives: This study, PRECIsE, assessed safety and performance of the first ssRAB iteration across multiple sites and nascent users.

Methods: This was a prospective, multicenter, observational study evaluating ssRAB without cone-beam computed tomography guidance in patients with nodules 10 to 30 mm located in or beyond the sub-segmental airways. Patients were followed for 2 years; the primary endpoint was sensitivity for malignancy with diagnostic yield, and safety as secondary endpoints. Multilevel logistic regression models were used to control for factors associated with sensitivity and diagnostic yield.

Results: A total of 305 procedures were performed across 6 centers. Median nodule size was 17.0 mm (IQR, 14.0-23.0) with bronchus sign present in 37% of cases. Sensitivity for malignancy through 2 years was 81.3% (95% CI, 75.7%-86.1%). Multilevel modeling demonstrated that female sex, smaller nodule size, lower lobe location, semi-solid density, and higher body mass index were associated with lower sensitivity. Diagnostic yield was 74.1% (95% CI, 68.8%-78.9%) according to the American Thoracic Society/American College of Chest Physicians (ATS/ACCP) criteria and 77.5% (95% CI, 72.4%-81.8%) according to the intermediate criteria. Multilevel modeling demonstrated a nonsignificant site/center-level effect on ATS/ACCP diagnostic yield (P = .36). Pneumothorax requiring intervention was 1.6% (5/305); bleeding was 1.0% (3/305) with 2 Nashville grade 2 events and one Nashville grade 3 event.

Conclusions: The first iteration of ssRAB demonstrated encouraging performance and a strong safety profile among nascent users for the biopsy of small peripheral nodules.