The PRECIsE Study: a prospective, multicenter study of shape-sensing robotic-assisted bronchoscopy with two years of follow-up
Recommended Citation
Ost DE, Folch EE, Reisenauer JS, Majid A, Casal RF, Keyes C, Parikh MS, Diaz-Mendoza J, Fernandez-Bussy S, Simoff MJ. The PRECIsE Study: a prospective, multicenter study of shape-sensing robotic-assisted bronchoscopy with two years of follow-up. Ann Am Thorac Soc. 2026.
Document Type
Article
Publication Date
3-3-2026
Publication Title
Ann Am Thorac Soc
Keywords
bronchoscopy; diagnostic yield; lung cancer; peripheral pulmonary nodules; sensitivity for malignancy
Abstract
INTRODUCTION: Guidelines recommend non-surgical 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. This study, PRECIsE, assessed safety and performance of the first ssRAB iteration across multiple sites and nascent users.
METHODS: Prospective, multicenter, observational study evaluating ssRAB without cone-beam CT guidance in patients with nodules 10-30 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). Multi-level modelling demonstrated 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 ATS/ACCP criteria and 77.5% [95% CI: 72.4, 81.8] according to the intermediate criteria. Multi-level modeling demonstrated a non-significant 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 two (2) Nashville grade 2 and one (1) Nashville grade 3 events.
CONCLUSIONS: The first iteration of ssRAB demonstrated encouraging performance and a strong safety profile among nascent users for the biopsy of small peripheral nodules.
PubMed ID
41773028
ePublication
ePub ahead of print
