Effect of needle size on outcomes of vacuum-assisted excision of breast lesions. A randomized controlled trial

Background: Utilizing a larger needle-size instead of a smaller one in vacuum-assisted excision of breast lesions might enhance the effectiveness of the method. We conducted a clinical trial to investigate the effects of needle size 7G compared to 10G regarding excision completeness and procedural efficiency.

Materials and methods: In this prospective, single-blinded, randomized clinical trial, the patients were enrolled between November 2019 and August 2022. Follow-up examinations were performed at 6 and 24 months after the procedure. In total, 208 patients were screened and enrolled, and following withdrawal of consent, the trial population comprised 194 patients. All patients with ultrasound-visible lesions of <30 mm in size and biopsy confirmation corresponding to a B2 or B3 lesion were included in the study. Additionally, patients with BI-RADS 3 and 4a microcalcifications measuring <15 mm were also eligible. Eighty-five percent of the patients attended the 6-month follow-up, and 65 % attended the 24-month follow-up.

Results: There were no significant difference between the two randomization arms in terms of age, and lesion size. The mean procedure time was 7.7 min and 8.5 min for 7G and 10G needle size, respectively (=0.126). Of the 164 patients who attended the 6-month follow-up, no remaining lesions were found in 90 % and 81.5 % (p = 0.109) patients for 7G and 10G needle size respectively. Thirty percent (6/20) of the patients with microcalcifications excised stereotactically, guided by mammography, had a residual lesion compared to 2.5 % (1/42) of the patients with intraductal lesions excised under ultrasound guidance.

Conclusions: Using a 10G compared to a 7G needle size resulted in no difference in procedure time or excision completeness. Among the analyzed parameters, only a larger lesion size was consistently associated with a longer procedure time and a higher risk of incomplete excision.