Abstract
OBJECTIVES: Hybrid operating rooms (HORs) incorporating robotic C-arm systems facilitate concurrent localization and resection of small pulmonary nodules, albeit with significant cost barriers. Contemporary mobile 3 D C-arm systems may provide superior soft tissue visualization with enhanced economic viability and accessibility. This prospective single-arm clinical pilot trial was designed to assess the technical feasibility, clinical efficacy, and procedural safety of employing mobile 3 D C-arm technology for single-stage localization and excision of small pulmonary nodules. METHODS: Patients presenting with small and/or deep-seated lung tumors necessitating preoperative localization were eligible for inclusion. Two distinct mobile 3 D C-arm systems (Cios Spin and Ziehm Vision RFD 3 D) were employed. The primary end-points included the rate of successful tumour localization and the time required to complete the localization procedure. Secondary end-points encompassed perioperative complications and radiation exposure. RESULTS: The study cohort included 41 patients with lung tumors measuring a median diameter of 7.30 mm (interquartile range [IQR]: 5.00-9.20 mm) and a median depth of 10.00 mm (IQR: 2.00-18.00 mm). Successful localization was achieved in 40 patients, yielding a success rate of 97.6%. In one case, inadequate lesion visualization using the mobile 3 D C-arm necessitated localization in a hybrid operating room. The mean localization time was 27.17 ± 10.38 min, and the median radiation exposure was 531.04 μGy m2 (IQR: [297.12-870.98] μGy m2). All patients were successfully discharged, with a median postoperative hospital stay of 3 days (IQR: 3-3 days). CONCLUSIONS: Our results support the technical feasibility, clinical efficacy, and procedural safety of mobile 3 D C-arm systems for single-stage localization and resection of small pulmonary nodules. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT04974632.