Abstract
OBJECTIVE: Inaccurate breast biopsy marker placement and marker migration during stereotactic biopsy procedures compromise their reliability for lesion localization and precise surgical excision. This trial evaluated the impact of 5-mm predeployment retraction of the marker introducer on marker migration, investigating other potential factors that influence the outcome. METHODS: This parallel, randomized controlled trial enrolled women aged ≥18 years undergoing stereotactic breast biopsy at a single institution from May 2020 through August 2022. The study was approved by the institutional review board at the University of Alabama at Birmingham (UAB). Patients were randomized to intervention (5-mm introducer retraction before marker deployment) or control (standard marker placement) by drawing a labeled paper. The primary outcome was the distance of marker migration on immediate postprocedure mammogram. RESULTS: Of 251 patients enrolled, 223 were analyzed; 104 received the intervention, and 119 received control. Mean (SD) marker migration was 12.1 (14.9) mm in the intervention group vs 9.8 (14.9) mm, with differences between groups estimated at 2.3 mm (SE = 1.9, P = .2312) (d = 0.16; 95% CI, 1.5-6.0). Effects of age, breast density, thickness, and biopsy approach showed no statistical significance. In exploratory models, central lesions exhibited 5.7 mm less migration than proximal lesions (95% CI, 0.7-10.6; P = .025), and each body mass index (BMI) unit increase was associated with 0.3 mm greater migration (95% CI, 0-0.6; P = .044). CONCLUSION: Retracting the marker introducer 5 mm before deployment did not reduce migration. Higher BMI and certain lesion locations were all associated with marker migration, highlighting the need to investigate biomechanical factors and techniques to optimize breast marker placement.Clinical Trials Registration: NCT04398537.