ArticleBMC surgery2025
Clinical outcomes of ultrasound-guided mammotome vacuum-assisted excision for benign breast tumors and its impact on serum tumor markers.
Article in BMC surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
backgroundUltrasound-guided vacuum-assisted excision (VAE) is widely used for benign breast lesions, but its systemic impact is unclear. We tested whether VAE increases serum CA15-3 at 3 months and described clinical outcomes.
methodsIn this prospective single-center cohort of 80 consecutive women with BI-RADS 3/4a lesions ≤ 30 mm undergoing Mammotome PRIMARY ENDPOINT: paired CA15-3 change at 3 months; noninferiority margin + 2 U/mL.
resultsTechnical success was achieved in 79/80 cases (98.8%, 95% CI: 93.3%-99.9%). Mean procedure time was 18 ± 5 min; Clavien-Dindo I-II complications occurred in seven patients (8.8%). Baseline CA 15 - 3 was 12.0 ± 4.0 U/mL and 11.7 ± 3.8 U/mL at 3 months (mean Δ - 0.3 U/mL, 95% CI: - 0.8 to 0.2, p = 0.24), satisfying the predefined non-inferiority margin. CEA and CA 125 likewise showed no clinically relevant change; the slight CA 125 decline (-1.0 U/mL, p = 0.040) lost significance after Bonferroni correction. Lesion-volume reduction at 1 month averaged 93% ± 6%, and BREAST-Q satisfaction at 3 months was 90 ± 7. One local recurrence (1.4%) was detected during 12-month surveillance.
conclusionsMammotome
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