Evaluating efficacy and safety of a novel registration-free CT-guided needle biopsy navigation system (RC 120): A multicenter, prospective clinical trial

Abstract

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.