Int J Surg. 2023 Apr 13. doi: 10.1097/JS9.0000000000000257. Online ahead of print.
ABSTRACT
BACKGROUND: Vacuum-assisted biopsy (VAB) and core needle biopsy (CNB) are both widely used methods in diagnosing breast lesions. We aimed to determine whether the Elite 10-gauge VAB achieves higher accuracy than the BARD spring-actuated 14-gauge CNB.
MATERIALS AND METHODS: This was a phase 3, open-label, parallel, randomized controlled trial (NCT04612439). In total, 1470 patients with ultrasound (US)-visible breast lesions requiring breast biopsy were enrolled from April to July 2021 and randomized at a 1:1 ratio to undergo VAB or CNB. All patients underwent surgical excision after needle biopsy. The primary outcome was accuracy, defined as the proportion of patients who had a consistent qualitative diagnosis between the biopsy and surgical pathology results. The underestimation rate, false-negative rate and safety evaluations were the secondary endpoints.
RESULTS: A total of 730 and 732 patients were evaluable for endpoints in the VAB and CNB groups, respectively. The accuracy of VAB surpassed that of CNB in the whole population (94.8% vs. 91.1%, P=0.009). The overall malignant underestimation rate was significantly lower in the VAB group than in the CNB group (21.4% vs. 30.9%, P=0.035). Additionally, significantly more false-negative events were noted in the CNB group (4.9% vs. 7.8%, P=0.037). In patients who presented with accompanying calcification, the accuracy of VAB surpassed that of CNB (93.2% vs. 88.3%, P=0.022). The potential superiority of VAB was indicated in patients with heterogeneous echo on US.
CONCLUSIONS: In general, the 10-G VAB procedure is a reasonable alternative to the 14-G CNB procedure with higher accuracy. We recommend the use of VAB for lesions with accompanying calcification or heterogeneous echo on US.
PMID:37042316 | DOI:10.1097/JS9.0000000000000257
