Real-time margin assessment for video-assisted thoracic surgery: A pilot clinical trial.

Objective: To accurately provide real-time intraoperative guidance on margins despite significant lung deformation. With lung cancer screening programs, smaller, early-stage lung nodules are being detected. Sublobar resection of peripheral small nodules is noinferior to lobar resection in terms of disease-free recurrence and long-term survival while preserving healthy lung function. However, accurately ensuring sufficient resection margin is challenging. Methods: A novel navigation system with a tumor marker (J-bar), surgical stapler instrumented with a position sensor, and software to compute the distances in real time has been developed and utilized during surgery to resect lung cancer. The software measurement of the J-bar to the tip of the stapler cutline (J-bar-tip) was compared with the distance measured from the resected sample in pathology. The aim was to establish the safety and feasibility of intraoperative use. Results: Twenty-five patients were enrolled in this study; 3 procedures were not included. For the 22 procedures: average nodule size = 17.5 mm, pleural surface distance = 8.0 mm with 5 nodules >20 mm from the surface. All patients underwent complete nodule resection. The median time to place the J-bar was 2.8 minutes and to clamp the sensorized surgical stapler at the first staple line was 1.8 minutes. There was a significant correlation between the software readings and the pathological J-bar-tip readings. There were no study-related anticipated or unanticipated adverse events related to the device. Conclusions: The safety and feasibility of using this novel navigation system to provide intraoperative distance from the J-bar to the stapler has been demonstrated.