Aim: Conventional bronchoscopy provides limited approach to peripheral lung nodules. The ION? Endoluminal System is a shape-sensing robotic-assisted bronchoscope in use in clinical practice in the US but currently no data describes robotic bronchoscopy in Europe.
Methods: A prospective, single-center, single-arm study conducted at Thoraxklinik Heidelberg evaluates the clinical utility of robotic-assisted bronchoscopy with ION? for biopsy of peripheral lung nodules (1-3cm in largest dimension) with follow-up up to 6 months. Primary outcome is rate of tool-in-nodule (TIN) confirmed via intraprocedural 3-D imaging with CIOS Spin. Secondary outcomes are procedural characteristics, diagnostic outcomes and adverse event rate.
Results: Twenty-three consecutive subjects with a median (IQR) nodule size of 20 (18,27)mm were included. Two procedures were stopped due to an endobronchial tumor or nodule resolution observed on imaging. Procedures were conducted by 2 interventionalists with a median (IQR) procedure time of 44 (30,60)min; procedure length decreased over time. Nodule visualization with radial EBUS was 86%; 76% of cases had ?2 CT spins performed. TIN was obtained in 100% (21/21) of cases where biopsy was attempted; in one case TIN was confirmed in 2-dimensions with a diagnosis of carcinoma. Follow-up of subjects is ongoing; preliminary findings are: 12 malignant, 5 non-malignant, 4 non-diagnostic cases with no adverse events reported including no pneumothorax.
Conclusion: Preliminary results for the first European cases show shape-sensing robotic-assisted bronchoscopy is a safe procedure with promising results for enabling diagnosis of peripheral lung lesions.