Comparison of robotic versus manual needle insertion for CT-guided intervention: prospective randomized trial

Robotic needle insertion under CT guidance has been developed, but data on comparison with manual insertion are still lacking.

To compare robotic versus manual needle insertion for CT fluoroscopy-guided intervention, primarily in terms of insertion accuracy.

This was a prospective study between May 2020 and March 2023 at a single site. The cohort comprised 22 patients undergoing CT (Aquilion One or Aquilion CX; Canon Medical Systems) fluoroscopy-guided biopsy, who were randomly allocated to either the robotic or manual group. The robot used (Zerobot; Medicalnet Okayama) is not yet commercially available. A biopsy introducer needle was inserted by 1 of 3 physicians using a remote-control robot in the robotic group, versus by 1 of 3 different physicians by hand in the manual group. The primary endpoint was needle insertion accuracy, which was defined as the 3-dimensional Euclidean distance between a predetermined target point and the needle tip after insertion. The non-inferiority of robotic insertion to manual one was then tested. Adverse events were evaluated. Statistical comparisons were made between the 2 groups.

Technical success and pathological findings were confirmed in all patients of the 2 groups. The mean and SD of needle insertion were 4.8 mm ± 2.6 in the robotic group and 7.0 mm ± 3.1 in the manual group (P < .001). The mean difference in accuracy between the 2 groups (robotic minus manual group) was -2.1 mm (95% CI, -4.7 to 0.4). Effective dose to physicians was zero in all cases in the robotic group, while median dose was 1.0 µSv in the manual group (P < .001). Dose length product to patients was not significantly different between the 2 groups (P = .100). No major adverse events were observed.

Robotic needle insertion was non-inferior to manual insertion in terms of accuracy, while it effectively eliminated radiation exposure to physicians.

jRCT2062200013.