Evaluating efficacy and safety of a novel registration-free CT-guided needle biopsy navigation system (RC 120): A multicenter, prospective clinical trial.
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BACKGROUND: Current percutaneous transthoracic needle biopsies (PTNB) navigation systems present challenges due to additional steps and limitations on the operating environment. RESEARCH QUESTION: We developed a novel, registration-free navigation system for swift and precise CT-guided PTNB, eliminating the need for body surface markers and intraoperative registration. This study assesses its efficacy and safety. METHODS: A prospective study was conducted on participants aged 18-80 years prepared for PTNB at two clinical centers, from December 2021 to August 2022. The primary endpoint was the success rate of biopsies within 2 needle adjustments, and the secondary endpoint was the success rate within a single adjustment. Safety endpoints were defined by adverse events occurrence. RESULTS: The study included 98 patients (median age, 64 years, IQR 54-69 years, 71 men). The primary endpoint achieved a biopsy success rate of 98.98 %, and the secondary endpoint demonstrated 97.96 %. The overall success rate was 98.98 %, significantly exceeding the target value of 85 % (P < 0.0001). The median number of CT scans was 3, significantly fewer than predicted for the manual puncture scheme [3 (IQR 3-3) to 8 (IQR 6-8), P < 0.0001]. The average procedure duration was 18.0 min (IQR: 14.0-29.0 min). The most common adverse events were hemorrhage (14 instances) and pneumothorax (8 instances). Other adverse events included elevated blood pressure, hemoptysis, and other common events. INTERPRETATION: Our registration-free navigation system proved to be an effective and safe system for assisting percutaneous lung biopsies in clinical practice.