Ultrasound-guided breast core needle biopsy (US-CNB): which size is optimal?

Transcription

1 Ultrasound-guided breast core needle biopsy (US-CNB): which size is optimal? Poster No.: C-2581 Congress: ECR 2017 Type: Authors: Keywords: DOI: Scientific Exhibit A. Mishra; Tripolis/LY Breast, Interventional non-vascular, Soft tissues / Skin, Ultrasound, Percutaneous, Ultrasound-Colour Doppler, Biopsy, Diagnostic procedure, Sampling, Cancer, Pathology, Neoplasia /ecr2017/C-2581 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. Page 1 of 20

2 Aims and objectives A preoperative histopathological diagnosis of a breast lump is imperative prior to any surgical intervention. A definitive diagnosis of a benign breast lump alleviates unnecessary fear and anxiety to the patient, while that of a malignant breast lump allows appropriate preoperative planning of treatment. Early work with percutaneous breast biopsy primarily involved FNAC. Presently, core biopsy appears to be preferable because of its better characterisation of lesions and lower incidence of insufficient samples. Percutaneous core needle biopsy (CNB) using automated biopsy gun has become routine as an alternative to open surgical biopsy since its first application in During the past 10 years, with the increasing experience of this procedure, ultrasound-guided CNB (US-CNB) has evolved as a highly sensitive, specific, and accurate method for the diagnosis of breast cancer. 2 Even with the widespread use of this procedure, there is still no known single protocol that is universally accepted. There are many variations in the technique of aspiration, size of needles, number of needle passes, etc. Recent studies investigating needle core biopsy underestimation rates have pointed to the potential variability associated with the differences in needle gauges. 3 Currently, there is a lack of information about the diagnostic difference between 14- and 16-gauge needles in ultrasound-guided core biopsy for breast lesions. In 1995, Nath et al 4 reported that biopsy samples obtained with a 14-gauge needle, compared with a 16- or 18-gauge needle, provided more accurate diagnostic results. Although 14G US-CNB provide a good tissue sampling but, on the other hand, a larger needle size potentially increases complications rate (hematomas, bleeding, vasovagal reactions). 5 In dense breasts, patients' comfort and compliance can be increased with a thinner 16G/18G needle. 6 There appears to be a lack of consensus on needle size selection for ultrasound-guided biopsies of lesions with different imagery features and with different breast architecture. Therefore, one may raise the question whether ultrasound-guided CNB with smaller needles, such as 16G and 18G, can have diagnostic value for ultrasound-visible lesions, and if there is any difference in the accuracy of biopsies of breast lesions with different needle sizes In this study, we present a series of breast lesions that underwent ultrasound-guided 14G, 16G/18G US-CNB followed by subsequent surgical excision or follow-up. We hypothesized that smaller gauge US-CNB provides results with similar accuracy and lesser patients' discomfort. The objective was to assess the accuracy of thinner needles for ultrasound visible breast lesions. The results of this study could allow the use of needles that are less expensive and less traumatic for the patient, without impairing the accuracy of the biopsy. Page 2 of 20

3 Methods and materials A non-randomised prospective study was conducted in Radiology department to determine the accuracy and complication rates of CNB, and the difference in results of 14-gauge versus 16-/18-gauge biopsy needles. Data on patients who received breast CNB during the period between May, 2013 to August, 2015 were collected. Total of 300 biopsies were included in the study. Inclusion criteria were availability of surgical histopathological result of the lesion or radiological follow-up (FUP) for atleast 6 months. The data collected included patient's age, lesion size ( > or < 10 mm.), needle size used, Breast Image Reporting and Data System (BI-RADS) 14 grade,, any complication (post - procedure hematoma / ecchymosis/ excessive bleeding), FUP interval change, CNB pathology report and final surgical pathologic report. CNB results were compared with surgical pathological results or with temporal evolution in all needle size groups. False negative rate (FNr), False positive rate (FPr), Negative predictive value (NPV), Positive predictive value (PPV), sensitivity, specificity, agreement rate (AGr), and instances of complications of CNB, and differences between results from 14- versus 16/18-gauge needles were compared. Ethical guidelines of the Declaration of Helsinki 15 were followed throughout. Informed consent was obtained for all biopsy procedures. All CNB were performed under ultrasound (US) guidance by same radiologist having over 8 years' experience. Ultrasound-guided procedures were performed with the patient in the supine or supine oblique position using free-hand technique. Imaging was performed with a high-resolution 5-12 MHz linear array transducer. A 14G or 16G/18G biopsy needle (Magnum, Bard, Covington, GA, USA) with a 22-mm throw was used; only one needle size was used for each lesion. Although the diameter of the 16G needle is less than that of the 14G needle by 0.4mm (19%), with their similar length of notch sample of 19mm, the estimated volume of sample notch is reduced by 22.7cmm. (34.5%). This would translate into a 1/3 reduction in the amount of tissue to be taken for histopathological examination. This core biopsy needle is attached to an automated spring-loaded biopsy device (Bard Magnum Reusable Core Biopsy Instrument, C. R. Bard Inc., Covington, GA 30014, U.S.). The procedure was performed under strict aseptic technique. The choice of needle size was determined primarily by lesion size and breast architecture. (Figure 1, 2) ml of local anaesthetic was instilled along the prospective trajectory of the needle. Direct visualization of the needle tip pre and post fire was the standard, together with an orthogonal image to ensure that the needle was within the lesion. 6 (Figure 3)Three specimens per lesion were obtained in all patients. (Figure 4). Postprocedural compression of puncture site and trajectory length was applied for atleast 15 minutes to obtain bleeding control. Patients with BI-RADS 3 lesion on imaging who underwent CNB, and did not receive surgical excision, were asked to return in 6 months for a follow-up ultrasound. If no significant interval changes were seen in the followup examination, then the lesions were regarded as likely benign. If the CNB and the final surgical pathologic results or 6-monthly interval change were compatible, the CNB was considered concordant (either true negative or true positive). The positive predictive Page 3 of 20

4 value for malignancy of each consecutively performed surgical excision was calculated by including DCIS and other invasive breast cancer cases. FNr was defined as initial CNB showing a benign result, but surgical biopsy revealing malignancy. FPr was defined as initial CNB showing a malignant result, but final surgical pathology revealing it to be benign. Sensitivity was defined as the true positives (TP) divided by the sum of TP and false negatives (FN), i.e., sensitivity = TP/(TP + FN). Specificity was defined as the true negatives (TN) divided by the sum of TN and false positives (FP), i.e., specificity = TN/ (TN + FP). Accuracy was calculated as TP and TN cases diagnosed by CNB as the ratio of total cases, i.e., accuracy = TP + TN/(TP + FN + TN+ FP). All results with p < 0.01 were considered statistically significant. All analyses were performed using SPSS 18.0, standard version (SPSS Inc., Chicago, IL, USA). Images for this section: Fig. 1: targeting a subcentimeter impalpable lesion with 14G needle. anuj mishra Page 4 of 20

5 Fig. 2: targeting palpable asymmetry with 14G needle anuj mishra Page 5 of 20

6 Fig. 3: subcentimeter lesion targeted with 18G needle anuj mishra Page 6 of 20

7 Fig. 4: subcentimeter lesion targeted with 16G needle anuj mishra Page 7 of 20

8 Results Out of 300 patients, 37.3% were below 40 years age and 74% were under 50 years age. Only 3.7% were above 70 years age. (Table 1). 136(45.3%) biopsies were performed with 16G/18G and 164(54.7%) with 14G needles. Of all patients biopsied with 14G needle, 73.8% were below 50 years age and of all patients biopsied with 16/18G needle, 74.7% were below 50 years age. 60% lesions biopsied were either labelled as BIRADS 4 or 5 on imaging and the rest were BIRADS 3 lesions. 36% of total biopsied were benign on histopathology and rest were either high-risk or malignant. (Table 2). The mean lesion size was 16 ± 8 mm in the 16G/18G group and 21 ± 11 mm in the 14G group. There were no differences in the breast lesion characteristics between the two gauges. Surgery was performed in 74% patients and the rest were followed-up for 6 months by imaging and none showed any change in morphology or any significant change in size. False-negative rates were 3.2 % for 16G/18G and 3.1% for 14G (p > 0.05); False-positive rates were 1.3% for 16G/18G and 0.6% for 14G; Negative predictive value was 96.7% for 16G/18G and 98.8% for 14G; Positive predictive value was 95.4% for 16G/18G and 99.3% for 14G; Sensitivity was 94% for 16/18G and 96% for 14G; Specificity was 83% for 16/18G and 93% for 14G; Agreement rates between histological findings of CNB and surgery were: 94 % for 16G/18G and 97 % for 14G and there was a statistical difference between the two gauges (P<0.01). (Tables 3,4). Diagnostic accuracy was lower for lesions #10 mm (p<.01). Results showed a significant trend toward a better agreement of CNB with increasing mass size. Indeed, false-negative rates of CNB were the highest and agreement rates were the lowest when mass size was #10 mm (accounting for 11.4% of CNB in the present study). Post-procedure hematoma/excessive bleeding around entry site was observed in : 1 (0.3%) 16/18G and 4 (1.3%) 14G. (P < 0.01). A comparison of the accuracy of the results obtained from 2 sizes of core biopsy needles use was made (Table 5). There was no significant difference between the two groups (p>0.05). However, bleeding and hematoma was observed much higher using a larger size 14G needle. Images for this section: Page 8 of 20

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10 Fig. 5: Table 1: Characteristics of ultrasound-guided 14G and 16G/18G CNB of breast lesions. anuj mishra Page 10 of 20

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12 Fig. 6: Table 2 : Histopathological findings of breast ultrasound -guided CNB. anuj mishra Page 12 of 20

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14 Fig. 7: Table 3: Core biopsy HPE result with 14G needle compared with the disease status. anuj mishra Page 14 of 20

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16 Fig. 8: Table 4: Core biopsy HPE result with 16G/18G needle compared with the disease status. anuj mishra Page 16 of 20

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18 Fig. 9: Table 5: Comparing the accuracy between 14g and 16G/18G. anuj mishra Page 18 of 20

19 Conclusion Large needle (14G) size is more accurate and has higher specificity and predictive values but are associated with higher risk of complications and increased morbidity. Smaller needles (16/18G) are quite accurate alternative despite lesion size. Personal information References 1. Parker SH, Jobe WE, Dennis MA, et al. US-guided automated large-core breast biopsy. Radiology 1993; 187: Wei X, Li Y, Zhang S, Zhu Y, Fan Y. Experience in large-core needle biopsy in the diagnosis of 1431 breast lesions. Med Oncol. 2011;28:429e433.\ 3. Destounis S, Skolny MN, Morgan R, et al. Rates of pathological underestimation for 9 and 12 gauge breast needle core biopsies at surgical excision. Breast Cancer. 2011;18: 42e50 4. Nath ME, Robinson TM, Tobon H, Chough DM, Sumkin JH. Automated large-core needle biopsy of surgically removed breast lesions: comparison of samples obtained with 14-, 16-,and 18-gauge needles. Radiology. 1995;197:739e Bruening W, Fontanarosa J, Tipton K, et al. Systematic review: comparative effectiveness of core-needle and open surgical biopsy to diagnose breast lesions. Ann Intern Med 2010; 152: Uematsu T, Kasami M, Uchida Y, et al. Ultrasonographically guided 18- gauge automated core needle breast biopsy with post-fire needle position verification (PNPV). Breast Cancer 2007, 14: Lai HW, Wu HK, Kuo SJ, et al. Differences in accuracy and underestimation rates for 14- versus 16-gauge core needle biopsies in ultrasound-detectable breast lesions. Asian J Surg 2013, 36: Margolin FR, Leung JW, Jacobs RP, et al. Percutaneous imaging-guided core breast biopsy: 5 years' experience in a community hospital. AJR Am J Roentgenol 2001,177: Zhou J, Tang J, Luo Y et.al. Impact of needle size and sonographic feature on accuracy of ultrasound#guided breast biopsy. Nan Fang Yi Ke Da Xue Xue Bao Jan;34(1):41# Yi J, Lee EH, Kwak JJ, et.al. Retrieval rate and accuracy of ultrasound# guided 14#G semi#automated core needle biopsy of breast microcalcifications. Korean J Radiol Jan#Feb;15(1):12#9. Page 19 of 20

20 11. Schueller G, Jaromi S, Ponhold L,et.al. US#guided 14#gauge core#needle breast biopsy: results of a validation study in 1352 cases. Radiology Aug;248(2):406# Kim H, Youk JH, Kim JA, et.al. US#guided 14G core needle biopsy: comparison between underestimated and correctly diagnosed breast cancers. Asian Pac J Cancer Prev. 2014;15(7):3179# Wiratkapun C, Treesit T, Wibulpolprasert B,et.al. Diagnostic accuracy of ultrasonography#guided core needle biopsy for breast lesions. Singapore Med J Jan;53(1):40# D'Orsi CJ, American College of Radiology. BI-RADS: mammography. In: D'Orsi CJ, editor. American College of radiology. Breast Imaging Reporting and Data System: ACR BI-RADS Breast Imaging Atlas. 4th ed. Reston, VA: American College of Radiology; Declaration of Helsinki. Ethical principles for medical research involving human subjects. First adopted in Helsinki, inland, Revised at the 52nd World Medical Association Assembly in Edinburgh, Scotland, Note of clarification on Paragraph 29 added by the World Medical Association Assembly, Washington, Page 20 of 20