curacy of specimen US for predicting resection margin status in women undergoing breast conserving therapy for US-detected cancer, having the histological findings as the reference standard.
Patients and methodsBetween April 2010 and March 2015, a total of 132 consecutive patients (age range, 34-87 years; mean, 51 years) underwent breast-conserving surgery (wire-guided lumpectomy or quadrantectomy) for US-detected invasive breast cancer. Mammography, breast US, US-guided core-needle biopsies (CNB) were performed in all cases. CNB was performed under sonographic guidance by using a 13 MHz probe (Sonosite, Bothell, WA, US) and a 14-gauge needle.In all patients, US-guided wire localization was performed approximately 6-12 hours before surgery by using a 20-gauge retractable hook-wire inserted into the lesion with a freehand technique. Accurate wire localization was confirmed with real-time ultrasound imaging and with additional radiographic images (two orthogonal views).Orienting surgical wires were placed on the edges of breast specimen at the time of surgery. All surgical specimens were accurately oriented and underwent US examination. Longitudinal and transverse US scans were performed in all cases by a single radiologist with more than 5 years experience in breast imaging.The presence of lesion within the specimen and its distance from the specimen margins in four radial directions (superior, inferior, medial and lateral) were assessed. US findings were then compared with the pathological ones.As reported by previous literature studies (9,(12)(13)(14)(15)(16)(17)(18)(19), sonographic threshold distance of 10 mm between the tumor and the surgical specimen margins was adopted in our series in order to classify the margin status. In particular, a <10 mm distance between the tumor and the specimen margins was considered as positive margins. In these cases, cavity shaves of the inadequate margin was immediately performed and additional removed tissue (re-excision specimen) did not undergo radiography or sonography. Sonographic margin status (negative or positive) was compared with the surgical pathology results.Histo-pathologic examination of the surgical specimens was performed by a pathologist with more than 20-years experience in breast disease, who examined both malignant specimen and re-excision tissue. The margin was considered positive/close if foci of DCIS or invasive carcinoma were found within the 2-mm thick shaved margin. Patients whose margins were involved were candidate for re-excision.Sensitivity, specificity, diagnostic accuracy, positive (PPV) and negative predictive values (NPV) of specimen ultrasound in predicting histological margins were evaluated, having the histological findings as the reference standard. True positives were represented by cases with sonographic margin of less than 10 mm, histologically confirmed as positive or close margin (2 mm); false positives by cases with sonographic positive margins, not confirmed at histology; true negatives by cases with sonographic margins of more th...