Efficacy and safety of a new disposable percutaneous positioning device invented to facilitate the precision of percutaneous core needle lung biopsies: a prospective, open and randomized controlled study

Background: A new disposable percutaneous positioning device was developed which permits adjustment of the fixing puncture angle while performing a percutaneous core needle lung biopsy (CNLB). The aim of the study was to explore the positioning accuracy and clinical safety of the new device during CT-guided percutaneous CNLB. Methods: A prospective, open and randomized controlled study with two parallel groups was conducted on 150 patients with pulmonary nodules between July 1, 2018 and June 30, 2019 including 101 males and 49 females who were divided (allocation ratio: 1:1) into a standard CNLB group without the percutaneous positioning device (control, n=75) and a new percutaneous positioning device group combined with CNLB (experimental, n=75). The efficacy was determined by the success rate of reaching the target location on the first percutaneous attempt, the number of CT scans performed and the time required for successful puncture positioning. Safety evaluations included complications related to percutaneous surgery and the new positioning device. Results: The success rate of reaching the target location on the first percutaneous attempt in the experimental group was significantly higher than in the control group [96.0% (72/75) vs. 42.7% (32/75), P<0.001]. Patients in the experimental group received 3.05±0.28 times CT scans on average for successful percutaneous positioning, which was significantly lower than for the control group (3.95±1.03) (P<0.001). The time required to complete the percutaneous positioning was significantly lower in the experimental group compared to the control group (8.73±3.11 vs. 12.79±4.55 min, P<0.001). There was no significant difference in percutaneous-related complications between the two groups [48.0% (36/75) vs. 61.3% (46/75), P=0.101], except that the bleeding rate in the experimental group was lower than in the control group [26.7% (20/75) vs. 46.7% (35/75), P=0.032]. Conclusions: The use of the optimized percutaneous technology with the new positioning device significantly improved the accuracy and precision of percutaneous lung biopsies. Trial Registration: ChiCTR-INR-17010322.