14-gauge Core Needle Biopsy Research Articles

Comparison of Diagnostic Sensitivity and Procedure-Related Pain of Concurrent Ultrasound-guided Fine-needle Aspiration and Core-needle Biopsy of Axillary Lymph Nodes in Patients with Suspected or Known Breast Cancer.

Conflicting data exist on the diagnostic sensitivity of core-needle biopsy (CNB) compared to fine-needle aspiration (FNA) in the evaluation of axillary lymph node metastasis from breast cancer. Our purpose was to evaluate the sensitivity of CNB and FNA using subsequent axillary surgery as the gold standard and to compare the patients' subjective pain levels for each biopsy method. This IRB-approved prospective study enrolled 140 patients from February 2014 to May 2019 with known or suspected breast cancer. Patients underwent both US-guided FNA and 14-gauge CNB of the same node with clip placement and rated their pain level using a verbal numerical rating scale of 0 to 10. The diagnostic sensitivities were determined by pathology of the surgically excised lymph node using the McNemar test of correlated proportions. Changes in pain scores for CNB and FNA were determined using the Wilcoxon rank sum test. A total of 94 patients had confirmatory excision of the biopsied node with nodal metastasis detected in 71.3% (67/94). The sensitivity of CNB for detection of nodal metastasis was 95.5% (64/67), while the sensitivity of FNA was 67.2% (45/67) (P < 0.05). Overall pain score ratings for CNB increased by 0.6 from baseline on an 11-point numerical rating scale, while overall pain score rating for FNA decreased by 0.2 from baseline (P < 0.05). Our study demonstrates that 14-gauge CNB has superior sensitivity for detection of axillary nodal metastases and mildly increased pain compared with 25-gauge FNA in patients with breast cancer.

Effectiveness of introducing a 20-gauge core biopsy needle with a core trap in EUS-FNA/B for diagnosing pancreatic cancer

BackgroundEndoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) is a standard method for pathological diagnosis of pancreatic solid lesions. The EchoTip ProCore 20G® (PC20), a 20-gauge biopsy needle with a forward-bevel core trap, has been available in Japan since 2015.MethodsWe compared the efficacy of the PC20 with that of the EchoTip ProCore 22G® (PC22) and Acquire 22G® (AC22) in EUS-FNA/B for diagnosing pancreatic cancer. This retrospective study included 191 patients with pancreatic cancer who underwent EUS-FNA/B using the PC20, PC22, or AC22 at our facility from April 2013 to October 2019. We investigated the patients’ clinical characteristics and the diagnostic accuracy and safety of each needle.ResultsA sufficient stroke length of puncture was secured in all patients. The maximum length under EUS was shorter with the AC22 (22.1 ± 2.2 mm) than PC20 (30.6 ± 0.7 mm, p < 0.01) and PC22 (30.3 ± 0.8 mm, p < 0.01). The histological accuracy was 96.4% with the PC20 but only 58.8% with the PC22 (adjusted p (p-adj) < 0.0001) and 75.0% with the AC22 (p-adj = 0.06). The diagnostic accuracy of the combination of histology and cytology was 96.4% with the PC20, while it was 72.1% with the PC22 (p-adj < 0.0001) and 91.7% with the AC22 (p-adj > 0.99). One patient (0.9%) in the PC20 group developed mild pancreatitis, but no adverse events occurred with the other needles.ConclusionsThe PC20 showed better diagnostic capability than the PC22. The diagnostic efficacy was similar between the PC20 and AC22. The high histological accuracy of the PC20 could be advantageous for lesions in which histological assessment is critical.

Atypical ductal hyperplasia: breast DCE-MRI can be used to reduce unnecessary open surgical excision.

To evaluate the diagnostic performance of dynamic contrast-enhanced (DCE)-MRI in predicting malignancy after percutaneous biopsy diagnosis of atypical ductal hyperplasia (ADH). In this retrospective study, 68 lesions (66 women) with percutaneous biopsy diagnosis of ADH and pre-operative breast DCE-MRI performed between January 2016 and December 2017 were included. Two radiologists reviewed in consensus mammography, ultrasound, and MR images. The final diagnosis after surgical excision was used as standard of reference. Clinical and imaging features were compared in patients with and without upgrade to malignancy after surgery. The diagnostic performance of DCE-MRI in predicting malignant upgrade was evaluated. A 9-gauge vacuum-assisted biopsy was performed in 40 (58.8%) cases and a 14-gauge core needle biopsy in 28 (41.2%) cases. Upgrade to malignancy was observed in 17/68 (25%) lesions, including 4/17 (23.5%) cases of invasive cancer and 13/17 (76.5%) cases of ductal carcinoma in situ (DCIS). In 16/17 (94.1%) malignant and 20/51 (39.2%) benign lesions, a suspicious enhancement could be recognized in DCE-MRI. The malignant lesion without suspicious enhancement was a low-grade DCIS (4mm size). Sensitivity, specificity, positive predictive value, and negative predictive value of DCE-MRI on predicting malignancy were respectively 94.1%, 60.7%, 44.4%, and 96.8%. No other clinical or imaging features were significantly different in patients with and without upgrade to malignancy. After a percutaneous biopsy diagnosis of ADH, malignancy can be ruled out in most of the cases, if no suspicious enhancement is present in the biopsy area at DCE-MRI. Breast DCE-MRI may be used to avoid surgery in more than half of the patients with final benign diagnosis. • Breast DCE-MRI can safely rule out malignancy if no suspicious enhancement is present in the biopsy area after a percutaneous biopsy diagnosis of ADH. • All cases of upgrade to high-grade DCIS and invasive cancers can be identified at breast DCE-MRI after a percutaneous biopsy diagnosis of ADH. • Breast DCE-MRI may be used to avoid surgery in more than half of the patients with final benign diagnosis.

Annual Trends in Ultrasonography-Guided 14-Gauge Core Needle Biopsy for Breast Lesions.

ObjectiveTo examine time trends in ultrasonography (US)-guided 14-gauge core needle biopsy (CNB) for breast lesions based on the lesion size, Breast Imaging-Reporting and Data System (BI-RADS) category, and pathologic findings.Materials and MethodsWe retrospectively reviewed consecutive US-guided 14-gauge CNBs performed from January 2005 to December 2016 at our institution. A total of 22,297 breast lesions were included. The total number of biopsies, tumor size (≤ 10 mm to > 40 mm), BI-RADS category (1 to 5), and pathologic findings (benign, high risk, ductal carcinoma in situ [DCIS], invasive cancer) were examined annually, and the malignancy rate was analyzed based on the BI-RADS category.ResultsBoth the total number of US scans and US-guided CNBs increased while the proportion of US-guided CNBs to the total number of US scans decreased significantly. The number of biopsies classified based on the tumor size, BI-RADS category, and pathologic findings all increased over time, except for BI-RADS categories 1 or 2 and category 3 (odds ratio [OR] = 0.951 per year, 95% confidence interval [CI]: 0.902, 1.002 and odds ratio = 0.979, 95% CI: 0.970, 0.988, respectively). Both the unadjusted and adjusted total malignancy rates and the DCIS rate increased significantly over time. BI-RADS categories 4a, 4b, and 4c showed a significant increasing trend in the total malignancy rate and DCIS rate.ConclusionThe malignancy rate in the results of US-guided 14-gauge CNB for breast lesions increased as the total number of biopsies increased from 2005 to 2016. This trend persisted after adjusting for the BI-RADS category.

Percutaneous Ultrasound-Guided Core Needle Biopsy: Comparison of 16-Gauge versus 14-Gauge Needle and the Effect of Coaxial Guidance in 1065 Breast Biopsies - A Prospective Randomized Clinical Noninferiority Trial.

Ultrasound-guided core needle biopsy (CNB) is considered the standard assessment to diagnose sonographically visible suspicious breast mass lesions. Based on nonrandomized trials, the current German guidelines recommend at least three cylinders with ≤ 14-gauge needle biopsy. However, no recommendation is made as to how many specimens are needed with a smaller needle size, such as 16-gauge, or if biopsy with coaxial guidance improves diagnostic accuracy and quality. Therefore, in a prospective monocentric unblinded randomized controlled clinical noninferiority trial, the diagnostic accuracy of 16-gauge versus 14-gauge core needle biopsy, with and without coaxial guidance, was evaluated. 1065 breast biopsies were included in order to analyze the number of core samples necessary to obtain an appropriate rate of diagnostic quality adequate for histological evaluation, and to achieve high diagnostic accuracy and diagnostic yield. Histological results were verified by surgery or long-term follow-up of at least two years up to five years. In order to obtain an additive diagnostic accuracy of > 99 %, a minimum of two cylinders with 14-gauge biopsy were required. The diagnostic accuracy and the diagnostic quality of 14-gauge biopsy were not affected by the coaxial technique. When performing a 16-gauge biopsy, five cylinders were required to achieve an additive diagnostic accuracy of > 99 %. Without coaxial guidance, 16-gauge CNB required at least three samples, whereas five needle passes with coaxial-guided 16-gauge biopsy were needed. The diagnostic accuracy and quality of ultrasound-guided 16-gauge core needle biopsy were inferior to the 14-gauge needle size, regardless of the use of a coaxial technique.

Perinodal fibrosis developed after ultrasonography-guided core-needle biopsy of a contrast-enhanced ultrasound-detected sentinel axillary node interferes with subsequent surgical sentinel node dissection.

To evaluate perinodal fibrosis after 14-gauge staging core-needle biopsy (CNB) of the axillary sentinel lymph node (SLN) identified using contrast-enhanced ultrasonography (CEUS) and its interference with subsequent surgical SLN dissection in breast cancer patients. Frequencies or means of main clinical, sonographic, pathological, and surgical characteristics were calculated. We also compared patient groups with and without perinodal pathological fibrosis. Forty-eight patients who underwent CEUS + CNB and axillary surgery were eligible for this cross-sectional study. Axillary surgical specimens showed perinodal fibrosis in 9/48 (18.7%) patients. Interference with SLN dissection was reported in 4/48 (8.3%) patients (two hematomas, three abnormal palpation findings, and four difficult dissections). The overall surgical detection rate of SLN was 43/48 (89.6%). In the majority of cases, perinodal fibrosis was described as moderate (4/9 [44.4%]) or severe (4/9 [44.4%]). The mean time elapsed between CEUS + CNB and axillary dissection was shorter in patients with perinodal fibrosis (P = .04). Interference with SLN dissection was only reported in patients with perinodal fibrosis (P < .001). Surgical SLN detection was successful in all nine cases in which perinodal pathological fibrosis or interference with SLN dissection was reported. Perinodal fibrosis may impair the surgical SLN dissection in early stage breast cancer patients who were staged using CEUS + CNB using a14-gauge needle.

Is core needle biopsy effective at diagnosing male breast lesions?

The objective of this study was to examine the diagnostic accuracy of sonographically guided core needle biopsy (CNB) of breast lesions in men. This was a retrospective study where we analyzed consecutive sonographically guided 14-gauge CNB results on 234 male breast lesions. The CNB accuracy is determined by the comparison between the CNB and its corresponding excisional biopsy or to long-term follow-up imaging. Sonographically guided CNB was effective to collect satisfactory samples from all 234 lesions. Out of those, 58.55% (137/234) were benign, 38.0% (89/234) were malignant, 1.71% (4/234) were papilloma with atypia and 1.71% (4/234) were atypical ductal hyperplasia lesions. Underestimation occurred in 3.4% (8/234) of the lesions. As for the detection of breast malignancy, the sensitivity of the CNB is 98.9%, specificity is 100%, negative predictive value is 99.3%, positive predictive value is 100%, false positive is 0% and false negative is 1.1%. The overall accuracy of sonographically guided CNB as a diagnostic tool is 99.6%. Sonographically guided 14-gauge CNB is an accurate, reliable and low invasive procedure for assessing breast lesions in men. Triple tests and follow-up checks of benign cases are essential for a successful breast biopsy program in men.

EUS-guided sampling with 25G biopsy needle as a rescue strategy for diagnosis of small subepithelial lesions of the upper gastrointestinal tract.

Background and study aims This study was designed to evaluate the impact of additional tissue obtained with endoscopic ultrasound (EUS)-guided 25-gauge core biopsy needle (25G-PC) following an unsuccessful fine-needle biopsy (FNB) performed with larger-bore needles for the characterization of gastrointestinal subepithelial lesions (GI-SELs). Patients and methods We prospectively collected and retrospectively analyzed information in our database from January 2013 to June 2017 for all patients with GI-SELs who received a EUS-guided FNB (EUS-FNB) with 25G-PC during the same procedure after failure of biopsy performed with larger-bore needle. Diagnostic yield, diagnostic accuracy and procedural complications were evaluated. Results Sixteen patients were included in this study, 10 men and 6 women, median age 67.8 (range 43 to 76 years). Five patients were found to have a SEL localized in the distal duodenum, five in the gastric antrum, two in the gastric fundus and four in the gastric body. The mean size of the lesions was 20.5 mm (range 18 – 24 mm). EUS-FNB with 25G-PC enabled final diagnosis in nine patients (56.2 %). Regarding the subgroup of duodenal lesions, the procedure was successful in four of five (80 %). Final diagnoses with EUS-guided sampling were GIST (n = 6), leiomyoma (n = 2) and metastatic ovarian carcinoma (n = 1). No procedure-related complications were recorded. Conclusion In patients with small GI-SELs, additional tissue obtained with 25G-PC could represents a “rescue” strategy after an unsuccessful procedure with larger-bore needles, especially when lesions are localized in the distal duodenum.

EUS-guided tissue sampling with a 20-gauge core biopsy needle for the characterization of gastrointestinal subepithelial lesions: A multicenter study.

Background and Objective:A new 20-gauge (G) biopsy needle with a core-trap technology has been developed with a large core size and enhanced flexibility. The aim of this multicenter study was to determine the feasibility, efficacy, and safety of EUS-guided fine-needle biopsy (EUS-FNB) with the new 20G needle in diagnosing subepithelial lesions (SELs).Materials and Methods:Retrospectively collected data from consecutive patients with SELs undergoing EUS-FNB with the 20G needle at five centers were analyzed.Results:A total of 50 SELs were included. The mean lesion size was 43.1 ± 17.5 mm. The lesion locations were esophagus (n = 1), stomach (n = 37), distal duodenum (n = 5), rectum (n = 6), and colon (n = 1). The procedure was technically feasible in all patients. Definitive diagnosis with full histological assessment including immunohistochemistry was obtained in 88% (44/50) of the patients. Considering malignant versus benign lesions, the sensitivity, specificity, positive predictive value, and negative predictive value were 85% (95% confidence interval [CI] 70.2–94.3), 100% (95% CI 58.7%–100%), 100% (95% CI 85.1%–100%), and 62.5 (95% CI 27.7–84.8), respectively. No major complications requiring additional care have been observed.Conclusions:In this multicenter study, we found that EUS-FNB with the new 20G core needle is an effective and safe method for the diagnosis of SELs with a high rate of producing adequate histological material and high diagnostic accuracy even from difficult-to-approach anatomical locations.

A prospective randomized trial of EUS-guided tissue acquisition using a 25-gauge core biopsy needle with and without a stylet.

Endoscopic ultrasound (EUS)-guided tissue acquisition has become the most effective method of obtaining specimens from a solid lesion adjacent to the gastrointestinal tract. No data exist regarding the use of a stylet in the core biopsy needle during EUS-guided tissue acquisition. The aims of this study were to evaluate the feasibility, safety, and diagnostic yield of a 25-gauge core biopsy needle without (S-) a stylet and to compare its performance with that of a 25-gauge core biopsy needle with (S+) a stylet in patients with solid lesions adjacent to the gastrointestinal tract. From November 2013 to January 2016, we performed 114 EUS-guided tissue acquisitions for the diagnosis of solid lesions adjacent to the gastrointestinal tract in a randomized controlled trial. Patients were randomly assigned to the S+ group (n = 57) or the S- group (n = 57). EUS-guided tissue acquisition was performed using a 25-gauge core biopsy needle without an on-site cytopathologist. There were no significant differences in technical success (100 vs. 100%, p = 1.000), the mean number of needle passes (7.0 ± 1.6 vs. 6.8 ± 1.5, p = 0.556), needle malfunction (0 vs. 1.8%, p = 1.000), or complications (1.8 vs. 0%, p = 1.000) between the S+ and S- groups. Both groups exhibited comparable outcomes with respect to cytological diagnostic accuracy (93.0 vs. 91.2%, p = 1.000) and histological diagnostic accuracy (86.0 vs. 87.7%, p = 1.000) for malignancy. The procedure time was significantly shorter in the S- group than in the S+ group (32.4 ± 11.7 vs. 39.7 ± 8.6min, p < 0.001). EUS-guided tissue acquisition using a 25-gauge core biopsy needle without a stylet did not decrease the diagnostic yield for malignancy and was associated with a shorter procedure time than that associated with a stylet.

Abstract P4-15-04: A longitudinal cohort study to identify risk factors for the development of invasive cancer in unresected DCIS

Abstract Background: The variable natural history of ductal carcinoma in situ (DCIS) remains poorly understood. Randomized trials of active surveillance versus guideline concordant care are currently underway: the Comparison of Operative to Monitoring and Endocrine Therapy (COMET) trial in the US, LOw Risk dcIS (LORIS) trial in the UK and Low Risk Dcis (LORD) in Europe. Given this context, we examined the outcomes of a contemporary group of women with DCIS who did not undergo initial surgical resection. Methods: A longitudinal cohort of women diagnosed with DCIS on needle biopsy who did not undergo initial surgical excision for ≥1 year were identified through the Cancer Registry with case note and death certificate review for subsequent outcomes. Results: Eighty-nine eligible women with DCIS alone diagnosed on needle biopsy (most with 14-gauge core needle biopsy) between 1998 and 2010 were identified. The mean age at diagnosis was 72 years (range 44-94 years) with mean follow-up (diagnosis to death, invasive disease or last review) of 62 months (range 12-180 months). Twenty-nine women (33%) developed histologically proven invasive breast cancer, 28 at the site of the initial DCIS biopsy, after a mean interval of 54 months (range 12-144 months): 14/29 (48%) women originally had high grade DCIS, 10/31 (32%) intermediate grade and 3/17 (18%) low grade DCIS (initial grade not known in 12). Time to detect a diagnosis of invasive breast cancer was associated with initial grade of DCIS (p=0.0016, log-rank test): after mean intervals of 41 months (high grade), 69 months (intermediate grade) and 78 months (low grade) respectively. Younger age was associated with development of invasive disease (p&amp;lt;0.003, Mann-Whitney U-Test). High grade (grade 3) invasive breast cancer exclusively occurred in women with a prior diagnosis of high grade DCIS. Invasion was more frequent in lesions with calcification as the predominant feature than those without (23/50 v. 5/25; p&amp;lt;0.05, Fisher exact test). Forty-four women were prescribed endocrine therapy, use of which was associated with a lower rate of invasive breast cancer (p&amp;lt;0.05). Ultimately 18 women underwent surgery, 17 for invasive cancer. The mean interval from DCIS diagnosis to death was 76 months for those who developed invasive cancer; 48/89 women died, 12 had a certified cause of death as breast cancer. Conclusion: High grade DCIS, mammographic microcalcification and lack of endocrine therapy were associated with progression to invasion. The findings suggest surgical excision of high grade DCIS should continue but provides support that women with DCIS features which include low grade should be considered for the COMET, LORIS or LORD active surveillance trials. Citation Format: Maxwell AJ, Clements K, Hilton B, Dodwell DJ, Evans A, Olive K, Pinder SE, Thomas J, Matthew WG, Thompson AM. A longitudinal cohort study to identify risk factors for the development of invasive cancer in unresected DCIS [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-15-04.

A prospective randomized trial of EUS-guided tissue acquisition using a 25-gauge core biopsy needle with and without a stylet for pancreas solid mass lesion

A prospective randomized trial of EUS-guided tissue acquisition using a 25-gauge core biopsy needle with and without a stylet for pancreas solid mass lesion

Ultrasound-guided cable-free 13-gauge vacuum-assisted biopsy of non-mass breast lesions.

PurposeTo compare the outcomes of ultrasound-guided core biopsy for non-mass breast lesions by the novel 13-gauge cable-free vacuum-assisted biopsy (VAB) and by the conventional 14-gauge semi-automated core needle biopsy (CCNB).Materials and methodsOur institutional review board approved this prospective study, and all patients provided written informed consent. Among 1840 ultrasound-guided percutaneous biopsies performed from August 2013 to December 2014, 145 non-mass breast lesions with suspicious microcalcifications on mammography or corresponding magnetic resonance imaging finding were subjected to 13-gauge VAB or 14-gauge CCNB. We evaluated the technical success rates, average specimen numbers, and tissue sampling time. We also compared the results of percutaneous biopsy and final surgical pathologic diagnosis to analyze the rates of diagnostic upgrade or downgrade.ResultsUltrasound-guided VAB successfully targeted and sampled all lesions, whereas CCNB failed to demonstrate calcification in four (10.3%) breast lesions with microcalcification on specimen mammography. The mean sampling time were 238.6 and 170.6 seconds for VAB and CCNB, respectively. No major complications were observed with either method. Ductal carcinoma in situ (DCIS) and atypical ductal hyperplasia (ADH) lesions were more frequently upgraded after CCNB (8/23 and 3/5, respectively) than after VAB (2/26 and 0/4, respectively P = 0.028).ConclusionNon-mass breast lesions were successfully and accurately biopsied using cable-free VAB. The underestimation rate of ultrasound-detected non-mass lesion was significantly lower with VAB than with CCNB.Trial registrationCRiS KCT0002267.

Ultrasonography-guided 14-gauge core biopsy of the breast: results of 7 years of experience.

PurposeThis study assessed the outcomes of ultrasound (US)-guided core needle biopsies (CNBs) of breast lesions with at least 2 years of follow-up to determine the false-negative rate and to evaluate the diagnostic accuracy of CNB.MethodsWe retrospectively analyzed 13,254 consecutive US-guided 14-gauge CNBs for breast lesions. We excluded biopsies if non-malignant biopsy result was not confirmed by surgical excision or US-guided vacuum-assisted biopsy, or fewer than 2 years of follow-up data were available. A total of 4,186 biopsies were excluded, and 9,068 breast masses from 7,039 women were included. The pathologic findings from each CNB were assessed using the standard diagnostic reference, defined based on the results of surgical excision, vacuum-assisted biopsy, or at least 2 years of long-term imaging follow-up. The false-negative rate and underestimation rate were calculated.ResultsOf the 9,068 CNBs, benign pathology was found in 64.2%, high-risk results in 3.5%, and malignant results in 32.3%. Of the 5,821 benign CNBs, an additional malignancy was found at excision in 63 lesions, leading to a false-negative rate of 2.0% (63 of 3,067). The underestimation rate was 33.6% (111 of 330) for ductal carcinoma in situ and 24.5% (79 of 322) for high-risk results at surgical excision. Most false-negative diagnoses (84.1%, 53 of 63) were recognized through imaging-histology correlations, and immediate rebiopsies were performed. Ten malignancies (15.9%, 10 of 63) had delayed diagnoses and showed progression in follow-up US imaging.ConclusionUS-guided 14-gauge CNB provided optimal diagnostic information. Imaging-histology correlations and appropriate imaging follow-up should be performed to avoid delayed diagnoses.

Management of Clinically and Mammographically Occult Benign Papillary Lesions Diagnosed at Ultrasound-Guided 14-Gauge Breast Core Needle Biopsy.

To determine how to manage clinically and mammographically occult benign papillary lesions diagnosed at ultrasound (US)-guided 14-gauge breast core needle biopsy (CNB) by evaluating their upgrade rates. From our pathologic database of US-guided 14-gauge breast CNB, 69 benign papillomas and 9 atypical papillomas with available subsequent excisional findings (surgery or vacuum-assisted removal with additional US follow-up for ≥2 years) or US follow-up alone (≥2 years) were included in this study. We analyzed their upgrade rates by using excisional or US follow-up findings, with no change at 2 years as the reference standard. Patient age, lesion size, lesion distance from the nipple, multiplicity, imaging-histologic concordance, and histologic findings were compared between groups with and without upgrades by statistical analysis. Surgical excision was performed in 53 (67.9%) of 78 benign papillary lesions and revealed 5 upgrades (11.4%) to atypical papillomas in 44 benign papillomas and 2 upgrades (22.2%) to ductal carcinomas in situ in 9 atypical papillomas. Among 12 benign papillomas (15.4%) with vacuum-assisted removal and US follow-up (≥2 years), 1 (8.3%) was upgraded to atypical papilloma. The remaining 13 benign papillomas (16.7%) were followed with US and were stable after a 2-year follow-up period. There were no significant differences in the variables between the groups. Uniform surgical excision is not a reasonable management strategy for clinically and mammographically occult benign papillary lesions diagnosed at US-guided 14-gauge breast CNB. Clinically and mammographically occult benign papillary lesions may be subsequently managed by vacuum-assisted removal or imaging follow-up if atypia is not found.

Mammographically Occult Asymptomatic Radial Scars/Complex Sclerosing Lesions at Ultrasonography-Guided Core Needle Biopsy: Follow-Up Can Be Recommended

An increasing number of radial scars are detected by ultrasound (US), but their management is controversial. This study investigated the upgrade rate in mammographically occult radial scars/complex sclerosing lesions without epithelial atypia at US-guided 14-gauge core needle biopsy in asymptomatic patients. Nineteen mammographically occult benign radial scars/complex sclerosing lesions (median size, 7 mm; range, 3–23 mm) were included. Patients underwent surgical excision (n = 10) or vacuum-assisted excision, with follow-up US at least 6 mo after benign vacuum-assisted excision results (n = 8), or underwent US follow-up for 2 y after core needle biopsy (n = 1). Any cases with change in diagnosis to high-risk lesions or malignancy at excision were considered upgrades. The upgrade rate was 0.0%. Based on US findings, 15.8% (3/19) were Breast Imaging Reporting and Data System (BI-RADS) category 3, 68.4% (13/19) were BI-RADS category 4a and 15.8% (3/19) were BI-RADS category 4b. Follow-up with US can be considered for mammographically occult benign radial scar/complex sclerosing lesions diagnosed by US core needle biopsy in asymptomatic patients.

Risks of Being Malignant or High Risk and Their Characteristics in Breast Lesions 20 mm or Larger After Benign Results on Ultrasonography-Guided 14-Gauge Core Needle Biopsy.

The malignancy risk, risk of being high-risk lesions after benign results on ultrasonography-guided 14-gauge core needle biopsies (US-CNBs), and their characteristics in breast lesions of 20 mm or greater were investigated. Eight hundred forty-seven breast lesions with benign results on US-CNB were classified as benign, high risk, and malignant through excision and clinical follow-up. The risks of being malignant or high risk were analyzed in all lesions, lesions 20 to 29 mm, and lesions 30 mm or greater. Their clinicopathological characteristics were evaluated. Of 847, 18 (2.1%) were malignant, 53 (6.3%) were high-risk lesions, and 776 (91.6%) were benign. Of 18 malignancies, 6 (33.3%) were malignant phyllodes tumors and 12 (66.7%) were carcinomas. In benign lesions 20 to 29 mm, risks of being malignant or high risk were 1.6% (9 of 566) and 4.4% (25 of 566). In 281 lesions 30 mm or greater, the risks of being malignant or high risk were 3.2% and 10%. The risk of being high risk in lesions 30 mm or greater was 10%, significantly higher than 4.4% of lesions 20 to 29 mm (P = 0.002). Excision can be considered in lesions measuring 20 mm or larger because of the 2.1% malignancy risk and the 6.3% risk of being high-risk lesions despite benign results on US-CNB. Excision should be considered in lesions measuring 30 mm or larger because of the 3.2% malignancy risk and the 10% risk of being high-risk lesions.

Asymptomatic Benign Papilloma Without Atypia Diagnosed at Ultrasonography-Guided 14-Gauge Core Needle Biopsy: Which Subgroup can be Managed by Observation?

For asymptomatic benign papillomas detected at ultrasonography-guided 14-gauge core-needle biopsy (US-CNB), the decision to perform excision versus observation has been a topic of debate. We sought to determine which subgroup of asymptomatic benign papillomas without atypia diagnosed at US-CNB can be safely managed by observation versus immediate excision. Overall, 230 asymptomatic benign papillomas in 197 women (mean age 46.6±9.5years; range 22-78), diagnosed at US-CNB using immunohistochemistry staining when needed and then managed by surgery (n=144) or vacuum-assisted excision (VAE) with at least 12months of follow-up after benign VAE results (n=86) were included in this study. The upgrade rate to malignancy was calculated. Clinical and radiological variables, including age, size, Breast Image Reporting and Data System (BI-RADS) category, and imaging-pathology correlation were evaluated to find associations with malignancy using multivariate analysis. The upgrade rate to malignancy was 2.6% (6 of 230): four were ductal carcinomas in situ and two were 1.5- and 9-mm-sized invasive ductal carcinomas without lymph node metastasis. The upgrade rates of papillomas with a BI-RADS category 3-4a and imaging-pathology concordance were 1.4 and 1.8%, respectively. Category 4b-5 and imaging-pathology discordance were independently associated with malignancy, with upgrade rates of 13 and 50%, respectively. Age and lesion size were not associated with malignancy. Asymptomatic benign papillomas with probable benign or low suspicious US features or imaging-pathology concordance can be followed-up as opposed to immediate excision.

Lesion stiffness measured by shear-wave elastography: Preoperative predictor of the histologic underestimation of US-guided core needle breast biopsy

ObjectivesTo determine whether lesion stiffness measured by shear-wave elastography (SWE) can be used to predict the histologic underestimation of ultrasound (US)-guided 14-gauge core needle biopsy (CNB) for breast masses. MethodsThis retrospective study enrolled 99 breast masses from 93 patients, including 40 high-risk lesions and 59 ductal carcinoma in situ (DCIS), which were diagnosed by US-guided 14-gauge CNB. SWE was performed for all breast masses to measure quantitative elasticity values before US-guided CNB. To identify the preoperative factors associated with histologic underestimation, patients' age, symptoms, lesion size, B-mode US findings, and quantitative SWE parameters were compared according to the histologic upgrade after surgery using the chi-square test, Fisher’s exact test, or independent t-test. The independent factors for predicting histologic upgrade were evaluated using multivariate logistic regression analysis. ResultsThe underestimation rate was 28.3% (28/99) in total, 25.0% (10/40) in high-risk lesions, and 30.5% (18/59) in DCIS. All elasticity values of the upgrade group were significantly higher than those of the non-upgrade group (P<0.001). On multivariate analysis, the mean (Odds ratio [OR]=1.021, P=0.001), maximum (OR=1.015, P=0.008), and minimum (OR=1.028, P=0.001) elasticity values were independently associated with histologic underestimation. The patients' age, lesion size, and final assessment category on US of the upgrade group were higher than those of the non-upgrade group (P=0.046 for age; P=0.021 for lesion size; P=0.030 for US category), but these were not independent predictors of histologic underestimation on multivariate analysis. ConclusionBreast lesion stiffness quantitatively measured by SWE could be helpful to predict the underestimation of malignancy in US-guided 14-gauge CNB.

Short-term follow-up in 6 months is unnecessary for asymptomatic breast lesions with benign concordant results obtained at ultrasonography-guided 14-gauge core needle biopsy

BackgroundWe investigated whether short-term follow-up in 6 months was appropriate for asymptomatic benign concordant lesions on ultrasonography-guided core needle biopsy (ultrasonography-guided CNB). MethodsOf 1,111 lesions, 944 underwent follow-up within 4 to 9 months after CNB, and 359 of 944 underwent a 2nd follow-up within 9 to 15 months. One hundred sixty-seven underwent a 1st follow-up within 9 to 15 months. Follow-up intervals were classified according to an interval of 6 and 12 months with 2 different methods. First, 944 and 167 lesions were classified into the 6- and 12-month groups. Second, 944 and 526 lesions (sum of 167 and 359 lesions) were classified into the 6- and 12-month groups. Clinicopathologic factors were compared between the 2 groups. ResultsNone of the benign concordant lesions were malignant; 1.4% of the lesions showed progression in the 6-month group, not significantly different from 1.2% and .8% of the 12-month group. Mean age, mean lesion size, final assessments, and specific or nonspecific pathologies were not different between the 2 groups. ConclusionsShort-term follow-up in 6 months is unnecessary for asymptomatic benign concordant breast lesions at ultrasonography-guided CNB.