Intraoperative ultrasound guided wire(IOUS-wire) localization biopsy versus preoperative fine needle aspiration cytology(FNAC) for early breast cancer with clinically positive nodes

Intraoperative ultrasound guided wire(IOUS-wire) localization biopsy versus preoperative fine needle aspiration cytology(FNAC) for early breast cancer with clinically positive nodes | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Intraoperative ultrasound guided wire(IOUS-wire) localization biopsy versus preoperative fine needle aspiration cytology(FNAC) for early breast cancer with clinically positive nodes Xue Song, Shijun Tan, Jiafa He, Xiaojie Lin, Lingling Ye, Shengying Chen, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6213557/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 22 Jul, 2025 Read the published version in World Journal of Surgical Oncology → Version 1 posted 17 You are reading this latest preprint version Abstract Background: The false-negative rate (FNR) of fine needle aspiration (FNA) for clinically positive (suspicious) lymph nodes (LNs) remains excessively high. Methods: We compared the feasibility and diagnostic efficiency of using a novel procedure to FNA for the assessment of clinically positive nodes in patients with early breast cancer. Between 1 January 2015 and 30 September 2023, 198 consecutive patients who consented to undergo axillary biopsy were referred to either the intraoperative ultrasound-guided wire localization group (IOUS-wire) or the ultrasound-guided fine needle aspiration group (US-FNAC). The primary endpoint was the false-negative rate (FNR) and accuracy rates of the two methods. One hundred patients were in the IOUS-wire group, whereas the other 98 patients were in the US-FNAC group. Results: The FNR of clinically positive lymph node biopsies was lower in the IOUS-wire localization group than in the US-FNAC group (16.1% versus 87.5%, p <0.001). Among the 32 successful identifications, 26 were in the IOUS-wire group. A total of 42 patients with additional lymph node metastases were found among FNAC-LN-negative patients by SLNB. The accuracy rates were 95% and 57.1% (p <0.001). No significant differences were observed in terms of complications or the median number of SLNs harvested between the groups. Conclusion: Compared with preoperative FNA, intraoperative US-guided wire localization biopsy is a feasible alternative procedure for cN1 patients, especially in luminal types breast cancer. This novel method is a clinical practice in China and should be further pursued as a potential biopsy method for the evaluation of axillary node status. breast cancer biopsy frozen section lymph node Figures Figure 1 Figure 2 Figure 3 Introduction Accurate axillary status is the most important determinant of the surgery and systemic adjuvant treatment in breast cancer patients 1 – 4 . In general, preoperative assessments of axillary lymph node(ALN) status include palpable examinations, imaging, and pathology via biopsy 5 . The National Comprehensive Cancer Network (NCCN) panel recommends pathologic confirmation of malignancy via US-FNAC or core needle biopsy (CNB) in patients with clinically positive lymph nodes (examination or imaging) 6 – 8 to determine whether sentinel lymph node biopsy(SLNB) is feasible. US-FNAC of suspicious lymph nodes is recognized as an optimal preoperative procedure with minimal complications for identifying patients with an indication for ALND 2 , 3 , 9 – 11 . However, findings from several studies have shown a relatively high false-negative rate and lower sensitivity 12 , 13 . The diagnostic performance depends on the impact of the clinician’s skill on the adequacy of sampling and the experience of the cytopathologist 14 . Besides, it usually takes two to three days to wait for the cytopathological results. In contrast, CNB has significantly better diagnostic accuracy than FNA, but it has greater complications such as bleeding and high costs in clinical practice 15 – 17 . Thus, it is possible to optimize the evaluation of axillary lymph node involvement before surgery. Over the years, wire-guided localization has been commonly used in guiding the removal of nonpalpable breast lumps. Recently, wire-guided localization has also been used for LN positioning in patients with clinically positive ALNs before neoadjuvant chemotherapy. A prospective study revealed that wire-guided localization combined with SLNB in patients with metastatic lymph nodes and neoadjuvant chemotherapy offers a high identification rate (100%) 18 . It's worth noting that frozen section pathology has been routinely used in most institutions in China because of the lower FNR and reduction in the risk of re-excision. SLNB with intraoperative frozen section pathology is recommended for patients with early-stage breast cancer. Therefore, we compared two cohorts of patients receiving either intraoperative ultrasound-guided wire (IOUS-wire) with frozen section pathology or pre-operative US-FNAC for patients with clinically suspicious lymph nodes. Methods Study design and population We searched for patients with early breast cancer who were candidates for SLNB with clinically suspicious lymph nodes at Guangdong Provincial Hospital of Chinese Medicine (Guangzhou City, Guangdong Province, P. R. China) from 1 January 2015 to 1 September 2023. Patients were excluded if they had a history of surgery around the areola region or in the outer upper quadrant of the breast or axillary region; or had undergone radiotherapy to the axilla; or had T3-4 tumors or bilateral primary breast cancer; or had previously undergone neoadjuvant chemotherapy; and were pregnant or breastfeeding. The study was approved by the ethics committee of the Guangdong Provincial Hospital of Chinese Medicine (ZE2023-454). All procedures were carried out in compliance with ethical standards and the principles of the Declaration of Helsinki. Written informed consent was obtained from all patients before treatment. Procedure Two procedures were performed by two different medical teams via standardized protocol in the same period to ensure that all operations were regulated. Nodal status was assessed by physical examination and ultrasound imaging before axillary surgery. The clinically suspicious lymph nodes are defined as any abnormal or enlarged clinically palpable lymph nodes or suspicious lymph nodes on imaging. The ultrasound characteristics of suspicious lymph nodes are as follows: a) the lymph node is round, and the surrounding envelope is not clear or irregularly lobed; b) the lymph node has cortical thickening > 3 mm and an eccentric hilum; and c) the lymph node has an absent hilum 19 , 20 . In the US-FNAC group, a high-frequency linear transducer (6–15 MHz) and a GE Logic E9® apparatus were utilized to identify the lymph nodes with morphological changes, so the aspirate was obtained from only one of them. The puncture was performed with a 23-gauge biopsy needle (GAQLLINIS.R. L Italy) on a 10 mL syringe (Fig. 1 A). To obtain the cytological material, the needle was moved in various directions, maintaining a vacuum that was undone before removal. In the lymph nodes with focal cortical thickening, aspiration was preferably performed in the altered region. A sonographic image was acquired showing the tip of the needle within the target lymph node (Fig. 1 B). Aspirates were either smeared on a slide and fixed in 95% ethanol or rinsed, fixed in a 50% ethanol/2% polyethylene glycol solution, and centrifuged, resulting in a monolayer preparation. Both smears and monolayer slides were Papanicolaou stained (Fig. 1 C). IOUS-wire localization was performed after the patient was under general anesthesia and before the incision was made. Based on the direction of the lymphatic tube and the position of the suspicious lymph node, the positioning wire (20G, LW0107, BARD) was pierced into the lymph node under the intraoperative guidance of ultrasound (Fig. 2 A, B, C). After the completion of suspicious lymph node localization, surgery was initiated immediately. The removed lymph nodes with the positioning guide wire were immediately sent to the pathology department for frozen section pathology. SLNB was performed in patients with negative biopsy results in the preoperation FNAC and with negative freezing results in intraoperative guidewire localization of lymph nodes. Before the skin incision, 1 ml of methylene blue (2 ml:20 mg, Jichuan Medical Pharmaceutical Company) was injected subcutaneously into the areola area and tumor periphery for 15 minutes before surgery. One milliliter of diluted indocyanine green (ICG) (2.5 mg/ml, Dandong Medical Pharmaceutical Company) was subsequently injected into the areola area and the upper outer quadrant of the breast. A fluorescence tracer system was used to visualize the subcutaneous lymph vessels and localize the SLNs (Fig. 2 D, E, F). All fluorescent or blue-stained lymph nodes along with any suspicious nodes were removed and sent for intraoperative frozen-section pathology. ALND (levels I and II) was performed according to the positive histological results of the suspicious lymph nodes or positive intraoperative frozen section evaluation of SLNs. All excised lymph nodes were subjected to final histopathological evaluation, which is considered the gold standard for determining the presence of metastasis according to the current institutional standards(Fig. 3 ). The primary outcome was the false-negative rate (FNR), which was defined as the number of patients who had negative biopsy results of clinically suspicious lymph nodes divided by the total number of patients who had positive lymph nodes. Quantitative variables are expressed as percentages. Statistical analysis The baseline and demographic characteristics of the enrolled population are summarized in Table 1 . The data were analyzed via SPSS(version 24.0), with P < 0.05 considered significant. Correlation of variables was assessed with Fisher’s exact test, χ² test, and Mann-Whitney U test. In the FNA group, sentinel lymph node biopsy will be performed in the operation if the preoperative FNA suggests a negative lymph node. Therefore, not only the FNA node but also additional sentinel lymph nodes were removed together and given frozen section pathology. Any of the removed sentinel lymph nodes that had a positive result were noted as positive. The lymph node that had a positive result was not necessarily the one that was punctured by the preoperative FNA. As a result, we calculate the FNR of the FNA group instead of the FNA procedure. Results From 1 January 2015 to 1 September 2023, 198 patients met the inclusion criteria. One hundred patients were in the IOUS-wire group, whereas the other 98 patients were in the US-FNAC group. The clinical and pathological characteristics of the patients are listed in Table 1 , and the study process is shown in Fig. 1 . We analyzed the mean number of resected SLNs, SLN identification rate, sensitivity (SE), specificity (SP), accuracy and FNR in the two groups. Based on the operation records, no significant difference was observed in the median number of SLNs harvested (5.3 versus 5.5; P = 0.631) between the two groups (Table 1 ). In total, 32 patients (16.2%) underwent ALND directly because they had positive biopsy results. A total of 166 patients (83.8%) underwent SLNB, 55 (33.1%) of whom subsequently underwent ALND. In the IOUS-wire group, the SLNs identified by MB + ICG dye are 98.0%, however, the suspicious lymph nodes found by wire alone without any dye are 15%. 26 patients (26%) with positive frozen-section pathology results underwent ALND directly, whereas 74 (74%) patients had negative results and received SLNB. Among the 74 patients, 69 (93.2%) had negative SLNB results, and 5 (6.8%) had positive SLNB results and subsequent ALND. The sensitivity (SE), specificity (SP), accuracy, and FNR were 83.9%, 100%, 95%, and 16.1%, respectively. The identification rates of SLNs by methylene blue, ICG, and wire localization were 85%,93%, and 100%, respectively. The detection rate of positive lymph nodes by methylene blue, ICG, and wire localization was 22%, 19%, and 26% respectively. In terms of results, more positive lymph nodes can be detected using the guide wire method. In the US-FNAC group, 6 patients (6.1%) with positive FNAC results underwent ALND directly. Ninety-two patients (93.9%) had negative results and received SLNB. Among the 92 patients, 42 (45.7%) had positive SLNB results and subsequent ALND, whereas 50 (54.3%) had negative SLNB results. The values for SE, SP, accuracy and FNR are 12.5%, 100%, 57.1%, and 87.5%, respectively. The results are summarized in Table 2 – 3 . Notably, the IOUS-wire group exhibited significantly greater sensitivity and accuracy than did the US-FNAC group (p < 0.001) (Table 3 ). Compared with that of the US-FNAC group, the FNR of the IOUS-wire group was substantially lower (p < 0.001). There was 100% specificity in both groups. The cost burden of the consumable material in surgery in the IOUS-wire group was 88 US dollars, which was less than that in the US-FNAC group (USD 109). There were no instances of hematoma, tracer-related allergic reactions, local inflammatory reactions, or skin or fat necrosis during or after the operation. Discussion Findings from the study have shown that the intraoperative ultrasound-guided wire localization method results in a significantly lower FNR than does FNAC in terms of biopsy of clinically suspicious lymph nodes. Additionally, no complications occurred, demonstrating the safety of this innovative technique. This study provides an alternative clinical biopsy procedure for the evaluation of suspicious axillary nodes. Currently, patients with suspicious nodes on physical examination and ultrasound imaging might receive US-guided FNAC according to the National Comprehensive Cancer Network (NCCN) guidelines 8 . If FNAC confirms positive axillary lymph nodes, patients can be referred directly for axillary lymph node dissection (ALND) 2 , 3 , 21 . However, findings from earlier studies have shown a relatively high false-negative rate (FNR) of 28.1%-31% for FNAC 12 , 13 , 21 , 22 . The sensitivity of US-FNAC depends on the size of the primary tumor and the appearance of the lymph nodes 2 , 21 , 23 . Some studies have also shown that diagnostic performance depends on the impact of the clinician’s skill on the adequacy of sampling and the experience of the cytopathologist 14 . Wire-guided localization is a simpler and more common method routinely used for guiding the excision of nonpalpable breast lesions 24 , 25 . It is also a safe method for accurately localizing axillary lymph nodes before surgery. A retrospective investigation of ultrasound-guided wire localization reported a 97% identification rate (IR) for the target lymph node 26 . Furthermore, sufficient tissue samples can be obtained for intraoperative frozen pathology so that the FNR is potentially reduced. Previous studies reported that frozen section pathology has an FNR of 5–10% in lymph node evaluations 27 . Therefore, we have further explored an alternative method to reduce the FNR in axillary lymph node biopsy. In contrast, we found a significant difference with the IOUS-wire localization method in terms of the FNR and the detection rate of positive lymph nodes due to the sufficient node sample and sensitivity of intraoperative frozen sectioning. Notably, this study has presented that the SLNs identified by MB + ICG dye are 98.0%, however, the suspicious lymph nodes found by wire alone without any dye are 15% in the wire group. Findings from this have suggested that clinically suspicious lymph nodes are not always detected by dual mapping. The use of a localized guidewire allows for the precise removal of suspicious lymph nodes, particularly those detected by ultrasound. Moreover, the IOUS-wire localization method significantly reduced costs and the time interval until a definitive operation was implemented. We can quickly obtain pathological results during the operation instead of waiting 2–3 days for FNAC results, indicating that patients will not have preoperative anxiety about waiting for cytological results. Finally, wire puncture is a minimally invasive method, so possible damage is unusual. The introduction of new methods has allowed the accurate diagnosis of axillary lymph nodes and provides an additional biopsy method for patients with clinically positive lymph nodes. This clinical practice is more appropriate for the national circumstances in China and Asia. Although FNAC has a relatively high FNR, several breast cancer guidelines recommend its utilization before axillary surgery. There is no consensus about when it is more suitable for use. Previous studies have evaluated the factors influencing US-FNAC sensitivity; primary tumor size was the only variable that had a significant effect, and variables such as age and molecular subtype had no significant relationship with lymph node involvement 28–40 . Nevertheless, the most important predictive factor for malignancy and positive US-FNAC results is morphological lymph node alterations. The sonographic findings demonstrating cortical thickening > 3 mm (especially those ≥ 6 mm) and the absence of a fatty hilum were strongly associated with positive FNAC results 28 , 29 . The size of the lymph nodes is not a reliable indicator of abnormal lymph nodes 14 , 28 , 30 . Accordingly, a good reason for a positive FNAC result is a larger primary tumor or the morphological lymph node alterations. Nonetheless, this study has several limitations. First, in restriction of the surgeons participating in our study to two medical groups treating breast cancer, we were able to standardize surgical procedures to provide a good comparison of the biopsy effect. We recorded no difference in the distribution of node status, disease stage, tumor type, or surgical type between the two cohorts to keep a minimum bias. Second, in some situations it would be better to know the status of the axilla to plan for neoadjuvant chemotherapy 8 . In the early years, the candidates for neoadjuvant chemotherapy were inflammatory breast cancer, T3-4, and N2-3 disease 31 . In recent years, it has been recommended for Her2 + disease and TNBC with cT2 or cN1 8 . Our retrospective analysis was conducted over a lengthy period time and enrolled patients many years ago when surgery was still the preferred treatment for early breast cancer. If these patients had been put in the present, we would have administered neoadjuvant chemotherapy under the guidelines. In addition, the results of a cross-sectional study on the current status of neoadjuvant chemotherapy for breast cancer in China revealed that only 17.5% of patients underwent preoperative neoadjuvant therapy 32 , which is lower than that reported in advanced countries. The most important reason for this situation is patients' concerns about postponing surgery and the lack of willingness to conserve breasts after neoadjuvant therapy, indicating that neoadjuvant therapy is not as well accepted in China as it is in Europe and the United States 33 , 34 . Therefore, the present study strategies are more appropriate for patients with luminal types and are limited to patients who were unsuitable or unwilling or had contraindications to neoadjuvant therapy with TNBC and HER2-positive subtypes. Third, the present study is not consistent with Z0011's principles because all patients were given ALND when frozen sections indicated sentinel lymph node metastasis. Notably, 27% of patients had non-sentinel lymph node metastases in Z0011. Besides, the contribution of systemic adjuvant therapy and radiotherapy should not be ignored. If patient compliance is poor or systematic therapies are insufficient, ALND is needed to compensate for it. Third, there are many types of puncture needles for FNA, which lead to different amounts of tissue being obtained and thus affect the pathological results. Overall, this study has not followed up on the long-term regional recurrence rate. Thus, the randomized trial is more reliable for the effectiveness of a surgical procedure. Conclusion Intraoperative ultrasound-guided wire (IOUS-wire) localization with frozen sections results in a lower FNR and, most likely, a precise removal of suspicious lymph nodes, particularly those that are not detected by dual mapping. IOUS-wire localization biopsy is convenient, simple, and inexpensive, we believe that this method will be further pursued as an alternative biopsy method for the evaluation of clinically node-positive, luminal-type patients with breast cancer in clinical practice. Table 1 Patient characteristics (n = 198) Characteristics Overall (n = 198) IOUS-wire group (n = 100) US-FNAC group (n = 98) P value (t/U/χ2 test) Age (years) 51.2(11.3) 50.48(11.5) 51.9(11.1) 0.369 Maximum diameter of suspicious lymph nodes(mm) 15.4(5.7) 15.6(5.4) 15.3(6.0) 0.741 Number of sentinel lymph nodes detected 5.4(2.6) 5.3(2.7) 5.5(2.6) 0.631 Proportion of axillae was palpable 0.444 No 166(83.8%) 86(86%) 80(81.6%) Yes 32(16.2%) 14(14%) 18(18.4%) Proportion of axillae was detected by imaging 0.783 No 14(7.1%) 8(8.0%) 6(6.1%) Yes 184(92.9%) 92(92.0%) 92(93.9%) Expression of Ki67 0.286 ≤ 20% 62(31.3%) 35(35.0%) 27(27.6%) > 20% 136(68.7%) 65(65.0%) 71(72.4%) Surgical management 0.118 Mastectomy 110(55.6%) 50(50.0%) 60(61.2%) Breast conserving surgery 88(44.4%) 50(50.0%) 38(38.8%) Histology 0.090 IDC 168(84.8%) 90(90.0%) 78(79.6%) ILC 9(4.5%) 2(2.0%) 7(7.1%) Others 21(10.6%) 8(8.0%) 13(13.3%) Pathological T status 0.578 pT1 95(48.0%) 45(45.0%) 50(51.0%) pT2 98(49.5%) 53(53.0%) 45(45.9%) pT3 5(2.5%) 2(2.0%) 3(3.1%) Pathological N status 0.346 pN0 107(54.0%) 60(60.0%) 47(48.0%) pN0(i+) 3(1.5%) 1(1.0%) 2(2.0%) pN1 59(29.8%) 28(28.0%) 31(31.6%) pN2 21(10.6%) 9(9.0%) 12(12.2%) pN3 8(4.0%) 2(2.0%) 6(6.1%) ER/PR status 0.476 Negative 39(19.7%) 22(22.0%) 17(17.3%) Positive 159(80.3%) 78(78.0%) 81(82.7%) HER2 status 0.773 Negative 117(59.4%) 60(60.6%) 57(58.2%) Positive 80(40.6%) 39(39.4%) 41(41.8%) IDC: invasive ductal carcinoma (no special type of breast carcinoma), ILC: invasive lobular carcinoma, ER: estrogen receptor, PR: progesterone receptor, HER2: human epidermal growth factor receptor 2. Table 2 Diagnostic performance in the IOUS-wire localization group and US-FNAC group Overall (n = 198) IOUS-wire group (n = 100) US-FNAC group (n = 98) P value (t/U/χ2 test) SLNB identified by MB + ICG dye 191(96.5%)) 98(98.0%) 93(94.9%) 0.277 Suspicious lymph nodes found by wire alone (for the wire group) without any dye 15(15.0%) / Biopsy results of suspicious lymph nodes < 0.001 Negative 166(83.8%) 74(74.0%) 92(93.9%) Positive 32(16.2) 26(26.0%) 6(6.1%) Results of SLNB < 0.001 Negative 119(71.7%) 69(93.2%) 50(54.3%) Positive 47(28.3%) 5(6.8%) 42(45.7%) Results of axillary lymph nodes 0.197 Negative 111(56.1%) 69(69.0%) 50(51.0%) Positive 87(43.9%) 31(31.0%) 48(49.0%) SLNB: sentinel lymph node biopsy Table 3 The FNR and cost efficiency of the IOUS-wire group and US-FNAC group IOUS-wire group (n = 100) US-FNAC group (n = 98) P value FNR 16.1% 87.5% < 0.001 Sensitivity 83.9% 12.5% < 0.001 Accuracy 95% 57.1% < 0.001 Specificity 100% 100% < 0.001 Cost(USD) 88 109 Complications 0 0 FNR: false-negative rate Declarations Ethics approval and consent to participate: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.This study was approved by the ethics committee of the Guangdong Provincial Hospital of Chinese Medicine(ZE2023-454). Consent for publication: Written informed consent for publication was obtained from all participants. Availability of data and material: We declared that materials described in the manuscript, including all relevant raw data, will be freely available to any scientist wishing to use them for non-commercial purposes, without breaching participant confidentiality. Competing Interest declaration: No conflicts of interest exist in the submission of this manuscript, and the manuscript has been approved by all the authors for publication. Funding ： Guangdong Provincial Medical Research, 2021KT1715 Authors' contributions ： Xue Song wrote the manuscript. Shijun Tan, Jiafa He, and Rui Xu collected the data. Xiaojie Lin and Lingling Ye were in charge of statistics. Shengying Chen constructed the diagram. Yan Dai and Qianjun Chen supervised the study. Acknowledgements: Not applicable. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6213557","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":442295919,"identity":"4f60b223-076b-43d7-898f-ebeab02c09d0","order_by":0,"name":"Xue Song","email":"","orcid":"","institution":"Guangdong Provincial Hospital of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Xue","middleName":"","lastName":"Song","suffix":""},{"id":442295920,"identity":"d9786e00-9e36-4d1a-a400-034b885a7ec3","order_by":1,"name":"Shijun Tan","email":"","orcid":"","institution":"Guangdong Provincial Hospital of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Shijun","middleName":"","lastName":"Tan","suffix":""},{"id":442295921,"identity":"4eef356d-4cb4-4e94-8c2c-96544e2c4780","order_by":2,"name":"Jiafa He","email":"","orcid":"","institution":"Guangdong Provincial Hospital of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Jiafa","middleName":"","lastName":"He","suffix":""},{"id":442295922,"identity":"845a1d56-c9ed-4c72-b0d6-ef627801538c","order_by":3,"name":"Xiaojie Lin","email":"","orcid":"","institution":"Guangdong Provincial Hospital of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Xiaojie","middleName":"","lastName":"Lin","suffix":""},{"id":442295923,"identity":"ca036142-d3f7-4514-953c-9d7bc41fd214","order_by":4,"name":"Lingling Ye","email":"","orcid":"","institution":"Guangdong Provincial Hospital of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Lingling","middleName":"","lastName":"Ye","suffix":""},{"id":442295924,"identity":"15815775-65dd-4d02-b589-57b1af7c2725","order_by":5,"name":"Shengying Chen","email":"","orcid":"","institution":"Guangdong Provincial Hospital of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Shengying","middleName":"","lastName":"Chen","suffix":""},{"id":442295925,"identity":"aef25f44-8834-4f84-b2d8-e20f97a0198b","order_by":6,"name":"Rui Xu","email":"","orcid":"","institution":"Guangdong Provincial Hospital of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Rui","middleName":"","lastName":"Xu","suffix":""},{"id":442295926,"identity":"7f8a366b-e62a-4f34-b8c9-e79fd7d36be0","order_by":7,"name":"Yan Dai","email":"","orcid":"","institution":"Guangdong Provincial Hospital of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Yan","middleName":"","lastName":"Dai","suffix":""},{"id":442295927,"identity":"d933b2d9-4b78-4d6b-968e-fca23c33384b","order_by":8,"name":"Qianjun Chen","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAApklEQVRIiWNgGAWjYHCC9M8/KiTk5EnRksbMcMbC2LCBBC1szIxtFYkMB4hVz9+e8Oxx4TyJBMYG5oePbhCjReLMg3Tjmdsk8tgZ2IyNc4jRYiCRkCDBu02imLGBh02aBC1zJBIbDpCgJU2at4EULUC/JBvOOCZhbNhMrF/423MSH3yoqZOTZ29++JgoLQwMOQkQmpk45SCQfoB4taNgFIyCUTAyAQDTji5jHgouVQAAAABJRU5ErkJggg==","orcid":"","institution":"Guangdong Provincial Hospital of Chinese Medicine","correspondingAuthor":true,"prefix":"","firstName":"Qianjun","middleName":"","lastName":"Chen","suffix":""}],"badges":[],"createdAt":"2025-03-12 15:53:24","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6213557/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6213557/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12957-025-03925-9","type":"published","date":"2025-07-22T15:57:04+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":82097653,"identity":"372bb5f6-28ff-4c31-adb3-6e55d7db9dc9","added_by":"auto","created_at":"2025-05-06 17:54:16","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":166935,"visible":true,"origin":"","legend":"\u003cp\u003eThe biopsy needle (1A). The needle is within the target lymph node, and the red arrow indicates the biopsy needle (1B). Thered arrow indicates the cytological tissue (1C).\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-6213557/v1/a084e96f256ce88a2646259b.png"},{"id":82097668,"identity":"616948b5-1ede-4d21-a93e-d7ec7a96f20d","added_by":"auto","created_at":"2025-05-06 17:54:16","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":280160,"visible":true,"origin":"","legend":"\u003cp\u003eThe guide wire (2A). The wire pierced the lymph node under the guidance of ultrasound (2B, C). The needle is within the target lymph node, and the red arrow indicates the biopsy needle (2D). The targeted lymph node along with the wire-positioned nodes was removed, and the red arrow indicates the node (E, F).\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-6213557/v1/cf683adca5acfcd4277ce83b.png"},{"id":82097656,"identity":"15c4a197-56cb-4f66-a6ed-cf511db80d7a","added_by":"auto","created_at":"2025-05-06 17:54:16","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":505183,"visible":true,"origin":"","legend":"\u003cp\u003eSchematic diagram of the study.\u003c/p\u003e","description":"","filename":"floatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-6213557/v1/43ed89538d46b52ae24d9e2d.png"},{"id":87756872,"identity":"dcfde24f-fbab-4f42-9113-6cb0a7ee6c53","added_by":"auto","created_at":"2025-07-28 16:10:00","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1729999,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6213557/v1/80a19b1f-00fd-431a-b930-7adda70be249.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Intraoperative ultrasound guided wire(IOUS-wire) localization biopsy versus preoperative fine needle aspiration cytology(FNAC) for early breast cancer with clinically positive nodes","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAccurate axillary status is the most important determinant of the surgery and systemic adjuvant treatment in breast cancer patients\u003csup\u003e\u003cspan additionalcitationids=\"CR2 CR3\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. In general, preoperative assessments of axillary lymph node(ALN) status include palpable examinations, imaging, and pathology via biopsy\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e. The National Comprehensive Cancer Network (NCCN) panel recommends pathologic confirmation of malignancy via US-FNAC or core needle biopsy (CNB) in patients with clinically positive lymph nodes (examination or imaging)\u003csup\u003e\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003eto determine whether sentinel lymph node biopsy(SLNB) is feasible. US-FNAC of suspicious lymph nodes is recognized as an optimal preoperative procedure with minimal complications for identifying patients with an indication for ALND\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e,\u003cspan additionalcitationids=\"CR10\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. However, findings from several studies have shown a relatively high false-negative rate and lower sensitivity\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. The diagnostic performance depends on the impact of the clinician\u0026rsquo;s skill on the adequacy of sampling and the experience of the cytopathologist\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e. Besides, it usually takes two to three days to wait for the cytopathological results. In contrast, CNB has significantly better diagnostic accuracy than FNA, but it has greater complications such as bleeding and high costs in clinical practice\u003csup\u003e\u003cspan additionalcitationids=\"CR16\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. Thus, it is possible to optimize the evaluation of axillary lymph node involvement before surgery. Over the years, wire-guided localization has been commonly used in guiding the removal of nonpalpable breast lumps. Recently, wire-guided localization has also been used for LN positioning in patients with clinically positive ALNs before neoadjuvant chemotherapy. A prospective study revealed that wire-guided localization combined with SLNB in patients with metastatic lymph nodes and neoadjuvant chemotherapy offers a high identification rate (100%)\u003csup\u003e18\u003c/sup\u003e. It's worth noting that frozen section pathology has been routinely used in most institutions in China because of the lower FNR and reduction in the risk of re-excision. SLNB with intraoperative frozen section pathology is recommended for patients with early-stage breast cancer.\u003c/p\u003e \u003cp\u003eTherefore, we compared two cohorts of patients receiving either intraoperative ultrasound-guided wire (IOUS-wire) with frozen section pathology or pre-operative US-FNAC for patients with clinically suspicious lymph nodes.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eStudy design and population\u003c/p\u003e \u003cp\u003eWe searched for patients with early breast cancer who were candidates for SLNB with clinically suspicious lymph nodes at Guangdong Provincial Hospital of Chinese Medicine (Guangzhou City, Guangdong Province, P. R. China) from 1 January 2015 to 1 September 2023. Patients were excluded if they had a history of surgery around the areola region or in the outer upper quadrant of the breast or axillary region; or had undergone radiotherapy to the axilla; or had T3-4 tumors or bilateral primary breast cancer; or had previously undergone neoadjuvant chemotherapy; and were pregnant or breastfeeding.\u003c/p\u003e \u003cp\u003e The study was approved by the ethics committee of the Guangdong Provincial Hospital of Chinese Medicine (ZE2023-454). All procedures were carried out in compliance with ethical standards and the principles of the Declaration of Helsinki. Written informed consent was obtained from all patients before treatment.\u003c/p\u003e \u003cp\u003eProcedure\u003c/p\u003e \u003cp\u003eTwo procedures were performed by two different medical teams via standardized protocol in the same period to ensure that all operations were regulated. Nodal status was assessed by physical examination and ultrasound imaging before axillary surgery. The clinically suspicious lymph nodes are defined as any abnormal or enlarged clinically palpable lymph nodes or suspicious lymph nodes on imaging. The ultrasound characteristics of suspicious lymph nodes are as follows: a) the lymph node is round, and the surrounding envelope is not clear or irregularly lobed; b) the lymph node has cortical thickening\u0026thinsp;\u0026gt;\u0026thinsp;3 mm and an eccentric hilum; and c) the lymph node has an absent hilum\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e,\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn the US-FNAC group, a high-frequency linear transducer (6\u0026ndash;15 MHz) and a GE Logic E9\u0026reg; apparatus were utilized to identify the lymph nodes with morphological changes, so the aspirate was obtained from only one of them. The puncture was performed with a 23-gauge biopsy needle (GAQLLINIS.R. L Italy) on a 10 mL syringe (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eA). To obtain the cytological material, the needle was moved in various directions, maintaining a vacuum that was undone before removal. In the lymph nodes with focal cortical thickening, aspiration was preferably performed in the altered region. A sonographic image was acquired showing the tip of the needle within the target lymph node (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eB). Aspirates were either smeared on a slide and fixed in 95% ethanol or rinsed, fixed in a 50% ethanol/2% polyethylene glycol solution, and centrifuged, resulting in a monolayer preparation. Both smears and monolayer slides were Papanicolaou stained (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eC).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eIOUS-wire localization was performed after the patient was under general anesthesia and before the incision was made. Based on the direction of the lymphatic tube and the position of the suspicious lymph node, the positioning wire (20G, LW0107, BARD) was pierced into the lymph node under the intraoperative guidance of ultrasound (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eA, B, C). After the completion of suspicious lymph node localization, surgery was initiated immediately. The removed lymph nodes with the positioning guide wire were immediately sent to the pathology department for frozen section pathology.\u003c/p\u003e \u003cp\u003eSLNB was performed in patients with negative biopsy results in the preoperation FNAC\u003c/p\u003e \u003cp\u003eand with negative freezing results in intraoperative guidewire localization of lymph nodes.\u003c/p\u003e \u003cp\u003eBefore the skin incision, 1 ml of methylene blue (2 ml:20 mg, Jichuan Medical Pharmaceutical Company) was injected subcutaneously into the areola area and tumor periphery for 15 minutes before surgery. One milliliter of diluted indocyanine green (ICG) (2.5 mg/ml, Dandong Medical Pharmaceutical Company) was subsequently injected into the areola area and the upper outer quadrant of the breast. A fluorescence tracer system was used to visualize the subcutaneous lymph vessels and localize the SLNs (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eD, E, F).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAll fluorescent or blue-stained lymph nodes along with any suspicious nodes were removed and sent for intraoperative frozen-section pathology. ALND (levels I and II) was performed according to the positive histological results of the suspicious lymph nodes or positive intraoperative frozen section evaluation of SLNs. All excised lymph nodes were subjected to final histopathological evaluation, which is considered the gold standard for determining the presence of metastasis according to the current institutional standards(Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe primary outcome was the false-negative rate (FNR), which was defined as the number of patients who had negative biopsy results of clinically suspicious lymph nodes divided by the total number of patients who had positive lymph nodes. Quantitative variables are expressed as percentages.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe baseline and demographic characteristics of the enrolled population are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The data were analyzed via SPSS(version 24.0), with P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 considered significant. Correlation of variables was assessed with Fisher\u0026rsquo;s exact test, χ\u0026sup2; test, and Mann-Whitney U test. In the FNA group, sentinel lymph node biopsy will be performed in the operation if the preoperative FNA suggests a negative lymph node. Therefore, not only the FNA node but also additional sentinel lymph nodes were removed together and given frozen section pathology. Any of the removed sentinel lymph nodes that had a positive result were noted as positive. The lymph node that had a positive result was not necessarily the one that was punctured by the preoperative FNA. As a result, we calculate the FNR of the FNA group instead of the FNA procedure.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eFrom 1 January 2015 to 1 September 2023, 198 patients met the inclusion criteria. One hundred patients were in the IOUS-wire group, whereas the other 98 patients were in the US-FNAC group. The clinical and pathological characteristics of the patients are listed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, and the study process is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. We analyzed the mean number of resected SLNs, SLN identification rate, sensitivity (SE), specificity (SP), accuracy and FNR in the two groups. Based on the operation records, no significant difference was observed in the median number of SLNs harvested (5.3 versus 5.5; P\u0026thinsp;=\u0026thinsp;0.631) between the two groups (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). In total, 32 patients (16.2%) underwent ALND directly because they had positive biopsy results. A total of 166 patients (83.8%) underwent SLNB, 55 (33.1%) of whom subsequently underwent ALND.\u003c/p\u003e \u003cp\u003eIn the IOUS-wire group, the SLNs identified by MB\u0026thinsp;+\u0026thinsp;ICG dye are 98.0%, however, the suspicious lymph nodes found by wire alone without any dye are 15%. 26 patients (26%) with positive frozen-section pathology results underwent ALND directly, whereas 74 (74%) patients had negative results and received SLNB. Among the 74 patients, 69 (93.2%) had negative SLNB results, and 5 (6.8%) had positive SLNB results and subsequent ALND. The sensitivity (SE), specificity (SP), accuracy, and FNR were 83.9%, 100%, 95%, and 16.1%, respectively. The identification rates of SLNs by methylene blue, ICG, and wire localization were 85%,93%, and 100%, respectively. The detection rate of positive lymph nodes by methylene blue, ICG, and wire localization was 22%, 19%, and 26% respectively. In terms of results, more positive lymph nodes can be detected using the guide wire method.\u003c/p\u003e \u003cp\u003eIn the US-FNAC group, 6 patients (6.1%) with positive FNAC results underwent ALND directly. Ninety-two patients (93.9%) had negative results and received SLNB. Among the 92 patients, 42 (45.7%) had positive SLNB results and subsequent ALND, whereas 50 (54.3%) had negative SLNB results. The values for SE, SP, accuracy and FNR are 12.5%, 100%, 57.1%, and 87.5%, respectively. The results are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003eNotably, the IOUS-wire group exhibited significantly greater sensitivity and accuracy than did the US-FNAC group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Compared with that of the US-FNAC group, the FNR of the IOUS-wire group was substantially lower (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). There was 100% specificity in both groups. The cost burden of the consumable material in surgery in the IOUS-wire group was 88 US dollars, which was less than that in the US-FNAC group (USD 109). There were no instances of hematoma, tracer-related allergic reactions, local inflammatory reactions, or skin or fat necrosis during or after the operation.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eFindings from the study have shown that the intraoperative ultrasound-guided wire localization method results in a significantly lower FNR than does FNAC in terms of biopsy of clinically suspicious lymph nodes. Additionally, no complications occurred, demonstrating the safety of this innovative technique. This study provides an alternative clinical biopsy procedure for the evaluation of suspicious axillary nodes.\u003c/p\u003e \u003cp\u003eCurrently, patients with suspicious nodes on physical examination and ultrasound imaging might receive US-guided FNAC according to the National Comprehensive Cancer Network (NCCN) guidelines\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. If FNAC confirms positive axillary lymph nodes, patients can be referred directly for axillary lymph node dissection (ALND)\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e,\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e. However, findings from earlier studies have shown a relatively high false-negative rate (FNR) of 28.1%-31% for FNAC\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e,\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e,\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e. The sensitivity of US-FNAC depends on the size of the primary tumor and the appearance of the lymph nodes\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e,\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e. Some studies have also shown that diagnostic performance depends on the impact of the clinician\u0026rsquo;s skill on the adequacy of sampling and the experience of the cytopathologist\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e. Wire-guided localization is a simpler and more common method routinely used for guiding the excision of nonpalpable breast lesions\u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e,\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e. It is also a safe method for accurately localizing axillary lymph nodes before surgery. A retrospective investigation of ultrasound-guided wire localization reported a 97% identification rate (IR) for the target lymph node\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e. Furthermore, sufficient tissue samples can be obtained for intraoperative frozen pathology so that the FNR is potentially reduced. Previous studies reported that frozen section pathology has an FNR of 5\u0026ndash;10% in lymph node evaluations\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e. Therefore, we have further explored an alternative method to reduce the FNR in axillary lymph node biopsy. In contrast, we found a significant difference with the IOUS-wire localization method in terms of the FNR and the detection rate of positive lymph nodes due to the sufficient node sample and sensitivity of intraoperative frozen sectioning. Notably, this study has presented that the SLNs identified by MB\u0026thinsp;+\u0026thinsp;ICG dye are 98.0%, however, the suspicious lymph nodes found by wire alone without any dye are 15% in the wire group. Findings from this have suggested that clinically suspicious lymph nodes are not always detected by dual mapping. The use of a localized guidewire allows for the precise removal of suspicious lymph nodes, particularly those detected by ultrasound. Moreover, the IOUS-wire localization method significantly reduced costs and the time interval until a definitive operation was implemented. We can quickly obtain pathological results during the operation instead of waiting 2\u0026ndash;3 days for FNAC results, indicating that patients will not have preoperative anxiety about waiting for cytological results. Finally, wire puncture is a minimally invasive method, so possible damage is unusual. The introduction of new methods has allowed the accurate diagnosis of axillary lymph nodes and provides an additional biopsy method for patients with clinically positive lymph nodes. This clinical practice is more appropriate for the national circumstances in China and Asia.\u003c/p\u003e \u003cp\u003e Although FNAC has a relatively high FNR, several breast cancer guidelines recommend its utilization before axillary surgery. There is no consensus about when it is more suitable for use. Previous studies have evaluated the factors influencing US-FNAC sensitivity; primary tumor size was the only variable that had a significant effect, and variables such as age and molecular subtype had no significant relationship with lymph node involvement\u003csup\u003e28\u0026ndash;40\u003c/sup\u003e. Nevertheless, the most important predictive factor for malignancy and positive US-FNAC results is morphological lymph node alterations. The sonographic findings demonstrating cortical thickening\u0026thinsp;\u0026gt;\u0026thinsp;3 mm (especially those\u0026thinsp;\u0026ge;\u0026thinsp;6 mm) and the absence of a fatty hilum were strongly associated with positive FNAC results\u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e,\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u003c/sup\u003e. The size of the lymph nodes is not a reliable indicator of abnormal lymph nodes\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e,\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e,\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e. Accordingly, a good reason for a positive FNAC result is a larger primary tumor or the morphological lymph node alterations.\u003c/p\u003e \u003cp\u003eNonetheless, this study has several limitations. First, in restriction of the surgeons participating in our study to two medical groups treating breast cancer, we were able to standardize surgical procedures to provide a good comparison of the biopsy effect. We recorded no difference in the distribution of node status, disease stage, tumor type, or surgical type between the two cohorts to keep a minimum bias. Second, in some situations it would be better to know the status of the axilla to plan for neoadjuvant chemotherapy\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. In the early years, the candidates for neoadjuvant chemotherapy were inflammatory breast cancer, T3-4, and N2-3 disease\u003csup\u003e\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u003c/sup\u003e. In recent years, it has been recommended for Her2\u0026thinsp;+\u0026thinsp;disease and TNBC with cT2 or cN1\u003csup\u003e8\u003c/sup\u003e. Our retrospective analysis was conducted over a lengthy period time and enrolled patients many years ago when surgery was still the preferred treatment for early breast cancer. If these patients had been put in the present, we would have administered neoadjuvant chemotherapy under the guidelines. In addition, the results of a cross-sectional study on the current status of neoadjuvant chemotherapy for breast cancer in China revealed that only 17.5% of patients underwent preoperative neoadjuvant therapy\u003csup\u003e\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e, which is lower than that reported in advanced countries. The most important reason for this situation is patients' concerns about postponing surgery and the lack of willingness to conserve breasts after neoadjuvant therapy, indicating that neoadjuvant therapy is not as well accepted in China as it is in Europe and the United States\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e,\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u003c/sup\u003e. Therefore, the present study strategies are more appropriate for patients with luminal types and are limited to patients who were unsuitable or unwilling or had contraindications to neoadjuvant therapy with TNBC and HER2-positive subtypes. Third, the present study is not consistent with Z0011's principles because all patients were given ALND when frozen sections indicated sentinel lymph node metastasis. Notably, 27% of patients had non-sentinel lymph node metastases in Z0011. Besides, the contribution of systemic adjuvant therapy and radiotherapy should not be ignored. If patient compliance is poor or systematic therapies are insufficient, ALND is needed to compensate for it. Third, there are many types of puncture needles for FNA, which lead to different amounts of tissue being obtained and thus affect the pathological results.\u003c/p\u003e \u003cp\u003eOverall, this study has not followed up on the long-term regional recurrence rate. Thus, the randomized trial is more reliable for the effectiveness of a surgical procedure.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIntraoperative ultrasound-guided wire (IOUS-wire) localization with frozen sections results in a lower FNR and, most likely, a precise removal of suspicious lymph nodes, particularly those that are not detected by dual mapping. IOUS-wire localization biopsy is convenient, simple, and inexpensive, we believe that this method will be further pursued as an alternative biopsy method for the evaluation of clinically node-positive, luminal-type patients with breast cancer in clinical practice.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePatient characteristics (n\u0026thinsp;=\u0026thinsp;198)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOverall\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;198)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIOUS-wire group\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;100)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eUS-FNAC group\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;98)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003cp\u003e(t/U/χ2 test)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e51.2(11.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e50.48(11.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e51.9(11.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.369\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMaximum diameter of suspicious lymph nodes(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e15.4(5.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15.6(5.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e15.3(6.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.741\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumber of sentinel lymph nodes detected\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.4(2.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.3(2.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5.5(2.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.631\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProportion of axillae was palpable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.444\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e166(83.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e86(86%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e80(81.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e32(16.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14(14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e18(18.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProportion of axillae was detected by imaging\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.783\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e14(7.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8(8.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e6(6.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e184(92.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e92(92.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e92(93.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExpression of Ki67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.286\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026le;\u0026thinsp;20%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e62(31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35(35.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e27(27.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;20%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e136(68.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e65(65.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e71(72.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurgical management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.118\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMastectomy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e110(55.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e50(50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e60(61.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBreast conserving surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e88(44.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e50(50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e38(38.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHistology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.090\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIDC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e168(84.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e90(90.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e78(79.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eILC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e9(4.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(2.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e7(7.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOthers\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e21(10.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8(8.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e13(13.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePathological T status\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.578\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003epT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e95(48.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45(45.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e50(51.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003epT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e98(49.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e53(53.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e45(45.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003epT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5(2.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(2.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e3(3.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePathological N status\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.346\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003epN0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e107(54.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e60(60.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e47(48.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003epN0(i+)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3(1.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1(1.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2(2.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003epN1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e59(29.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28(28.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e31(31.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003epN2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e21(10.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9(9.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e12(12.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003epN3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e8(4.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(2.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e6(6.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eER/PR status\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.476\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNegative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e39(19.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22(22.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e17(17.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePositive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e159(80.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e78(78.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e81(82.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHER2 status\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.773\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNegative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e117(59.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e60(60.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e57(58.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePositive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e80(40.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e39(39.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e41(41.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eIDC: invasive ductal carcinoma (no special type of breast carcinoma), ILC: invasive lobular carcinoma, ER: estrogen receptor, PR: progesterone receptor, HER2: human epidermal growth factor receptor 2.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDiagnostic performance in the IOUS-wire localization group and US-FNAC group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOverall\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;198)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIOUS-wire group\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;100)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eUS-FNAC group\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;98)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003cp\u003e(t/U/χ2 test)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSLNB identified by MB\u0026thinsp;+\u0026thinsp;ICG dye\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e191(96.5%))\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e98(98.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e93(94.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.277\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuspicious lymph nodes found by wire alone (for the wire group) without any dye\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e15(15.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e/\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBiopsy results of suspicious lymph nodes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNegative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e166(83.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e74(74.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e92(93.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePositive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e32(16.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e26(26.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6(6.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResults of SLNB\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNegative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e119(71.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e69(93.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e50(54.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePositive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e47(28.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5(6.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e42(45.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResults of axillary lymph nodes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.197\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNegative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e111(56.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e69(69.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e50(51.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePositive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e87(43.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e31(31.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e48(49.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eSLNB: sentinel lymph node biopsy\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThe FNR and cost efficiency of the IOUS-wire group and US-FNAC group\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIOUS-wire group\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;100)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eUS-FNAC group\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;98)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFNR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e87.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSensitivity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e83.9%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12.5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAccuracy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e57.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpecificity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e100%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCost(USD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e109\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eComplications\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eFNR: false-negative rate\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u0026nbsp;\u003c/strong\u003eAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.This study was approved by the ethics committee of the Guangdong Provincial Hospital of Chinese Medicine(ZE2023-454).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u003c/strong\u003e Written informed consent for publication was obtained from all participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and material:\u0026nbsp;\u003c/strong\u003eWe declared that materials described in the manuscript, including all relevant raw\u0026nbsp;data, will be freely available to any scientist wishing to use them for non-commercial purposes, without breaching participant confidentiality.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interest declaration:\u0026nbsp;\u003c/strong\u003eNo conflicts of interest exist in the submission of this manuscript, and the manuscript has been approved by all the authors for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003cstrong\u003e：\u003c/strong\u003eGuangdong Provincial Medical Research, 2021KT1715\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003cstrong\u003e：\u003c/strong\u003eXue Song wrote the manuscript. Shijun Tan, Jiafa He, and Rui Xu collected the data. Xiaojie Lin and Lingling Ye were in charge of statistics. Shengying Chen constructed the diagram. Yan Dai and Qianjun Chen supervised the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u0026nbsp;\u003c/strong\u003eNot applicable.\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHolwitt DM, Swatske ME, Gillanders WE, et al: Scientific Presentation Award: The combination of axillary ultrasound and ultrasound-guided biopsy is an accurate predictor of axillary stage in clinically node-negative breast cancer patients. Am J Surg 196:477-82, 2008\u003c/li\u003e\n\u003cli\u003eKoelliker SL, Chung MA, Mainiero MB, et al: Axillary lymph nodes: US-guided fine-needle aspiration for initial staging of breast cancer--correlation with primary tumor size. Radiology 246:81-9, 2008\u003c/li\u003e\n\u003cli\u003eKrishnamurthy S, Sneige N, Bedi DG, et al: Role of ultrasound-guided fine-needle aspiration of indeterminate and suspicious axillary lymph nodes in the initial staging of breast carci noma. Cancer 95:982-8, 2002\u003c/li\u003e\n\u003cli\u003eFisher B, Bauer M, Wickerham DL, et al: Relation of number of positive axillary nodes to the prognosis of patients with primary breast cancer. An NSABP update. Cancer 52:1551-7, 1983\u003c/li\u003e\n\u003cli\u003eCardoso F, Kyriakides S, Ohno S, et al: Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up\u0026dagger;. Ann Oncol 30:1194-1220, 2019\u003c/li\u003e\n\u003cli\u003eRocha RD, Girardi AR, Pinto RR, et al: Axillary ultrasound and fine-needle aspiration in preoperative staging of axillary lymph nodes in patients with invasive breast cancer. Radiologia Brasileira 48:345-352, 2015\u003c/li\u003e\n\u003cli\u003ePyo J-S, Jung J, Lee SG, et al: Diagnostic Accuracy of Fine-Needle Aspiration Cytology and Core-Needle Biopsy in the Assessment of the Axillary Lymph Nodes in Breast Cancer -A Meta-Analysis. Diagnostics (Basel, Switzerland) 10:717, 2020\u003c/li\u003e\n\u003cli\u003eGradishar WJ, Moran MS, Abraham J, et al: NCCN Guidelines\u0026reg; Insights: Breast Cancer, Version 4.2023. J Natl Compr Canc Netw 21:594-608, 2023\u003c/li\u003e\n\u003cli\u003eKuenen-Boumeester V, Menke-Pluymers M, de Kanter AY, et al: Ultrasound-guided fine needle aspiration cytology of axillary lymph no des in breast cancer patients. A preoperative staging procedure. European journal of cancer (Oxford, England : 1990) 39:170-4, 2003\u003c/li\u003e\n\u003cli\u003eFung AD, Collins JA, Campassi C, et al: Performance characteristics of ultrasound-guided fine-needle aspiratio n of axillary lymph nodes for metastatic breast cancer employing rapid on-site evaluation of adequacy: analysis of 136 cases and review of t he literature. Cancer cytopathology 122:282-91, 2014\u003c/li\u003e\n\u003cli\u003eUsmani S, Ahmed N, Al Saleh N, et al: The clinical utility of combining pre-operative axillary ultrasonography and fine needle aspiration cytology with radionuclide guided sentinel lymph node biopsy in breast cancer patients with palpable axillary lymph nodes. Eur J Radiol 84:2515-20, 2015\u003c/li\u003e\n\u003cli\u003eLeenders MWH, Broeders M, Croese C, et al: Ultrasound and fine needle aspiration cytology of axillary lymph nodes in breast cancer. To do or not to do? Breast (Edinburgh, Scotland) 21:578-83, 2012\u003c/li\u003e\n\u003cli\u003eKane G, Fleming C, Heneghan H, et al: False-negative rate of ultrasound-guided fine-needle aspiration cytolo gy for identifying axillary lymph node metastasis in breast cancer patients. The breast journal 25:848-852, 2019\u003c/li\u003e\n\u003cli\u003eKrishnamurthy S, Sneige N, Bedi DG, et al: Role of ultrasound-guided fine-needle aspiration of indeterminate and suspicious axillary lymph nodes in the initial staging of breast carcinoma. Cancer 95:982-8, 2002\u003c/li\u003e\n\u003cli\u003eBalasubramanian I, Fleming CA, Corrigan MA, et al: Meta-analysis of the diagnostic accuracy of ultrasound-guided fine-nee dle aspiration and core needle biopsy in diagnosing axillary lymph nod e metastasis. The British journal of surgery 105:1244-1253, 2018\u003c/li\u003e\n\u003cli\u003eNakamura R, Yamamoto N, Miyaki T, et al: Impact of sentinel lymph node biopsy by ultrasound-guided core needle biopsy for patients with suspicious node positive breast cancer. Breast Cancer 25:86-93, 2018\u003c/li\u003e\n\u003cli\u003eVidya R, Iqbal FM, Bickley B: Pre-operative axillary staging: should core biopsy be preferred to fine needle aspiration cytology? Ecancermedicalscience 11:724, 2017\u003c/li\u003e\n\u003cli\u003eGarc\u0026iacute;a-Novoa A, Acea-Nebril B, D\u0026iacute;az Carballada C, et al: Combining Wire Localization of Clipped Nodes with Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Node-Positive Breast Cancer: Preliminary Results from a Prospective Study. Annals of surgical oncology 28:958-967, 2021\u003c/li\u003e\n\u003cli\u003eChoi YJ, Ko EY, Han B-K, et al: High-resolution ultrasonographic features of axillary lymph node metas tasis in patients with breast cancer. Breast (Edinburgh, Scotland) 18:119-22, 2009\u003c/li\u003e\n\u003cli\u003eMarino MA, Avendano D, Zapata P, et al: Lymph Node Imaging in Patients with Primary Breast Cancer: Concurrent Diagnostic Tools. The oncologist 25:e231-e242, 2020\u003c/li\u003e\n\u003cli\u003eMainiero MB, Cinelli CM, Koelliker SL, et al: Axillary ultrasound and fine-needle aspiration in the preoperative evaluation of the breast cancer patient: an algorithm based on tumor size and lymph node appearance. AJR Am J Roentgenol 195:1261-7, 2010\u003c/li\u003e\n\u003cli\u003eGipponi M, Fregatti P, Garlaschi A, et al: Axillary ultrasound and Fine-Needle Aspiration Cytology in the preoper ative staging of axillary node metastasis in breast cancer patients. Breast (Edinburgh, Scotland) 30:146-150, 2016\u003c/li\u003e\n\u003cli\u003eYang WT, Ahuja A, Tang A, et al: High resolution sonographic detection of axillary lymph node metastase s in breast cancer. Journal of ultrasound in medicine : official journal of the American I nstitute of Ultrasound in Medicine 15:241-6, 1996\u003c/li\u003e\n\u003cli\u003eDave RV, Barrett E, Morgan J, et al: Wire- and magnetic-seed-guided localization of impalpable breast lesio ns: iBRA-NET localisation study. The British journal of surgery 109:274-282, 2022\u003c/li\u003e\n\u003cli\u003eHartmann S, Reimer T, Gerber B, et al: Wire localization of clip-marked axillary lymph nodes in breast cancer patients treated with primary systemic therapy. European journal of surgical oncology : the journal of the European So ciety of Surgical Oncology and the British Association of Surgical Onc ology 44:1307-1311, 2018\u003c/li\u003e\n\u003cli\u003ePlecha D, Bai S, Patterson H, et al: Improving the Accuracy of Axillary Lymph Node Surgery in Breast Cancer with Ultrasound-Guided Wire Localization of Biopsy Proven Metastatic Lymph Nodes. Annals of Surgical Oncology 22:4241-4246, 2015\u003c/li\u003e\n\u003cli\u003eWong J, Yong WS, Thike AA, et al: False negative rate for intraoperative sentinel lymph node frozen sect ion in patients with breast cancer: a retrospective analysis of patien ts in a single Asian institution. Journal of clinical pathology 68:536-40, 2015\u003c/li\u003e\n\u003cli\u003eKoelliker SL, Chung MA, Mainiero MB, et al: Axillary lymph nodes: US-guided fine-needle aspiration for initial sta ging of breast cancer--correlation with primary tumor size. Radiology 246:81-9, 2008\u003c/li\u003e\n\u003cli\u003eDeurloo EE, Tanis PJ, Gilhuijs KG, et al: Reduction in the number of sentinel lymph node procedures by preoperative ultrasonography of the axilla in breast cancer. Eur J Cancer 39:1068-73, 2003\u003c/li\u003e\n\u003cli\u003eKrishnamurthy S: Current applications and future prospects of fine-needle aspiration biopsy of locoregional lymph nodes in the management of breast cancer. Cancer 117:451-62, 2009\u003c/li\u003e\n\u003cli\u003eGoetz MP, Gradishar WJ, Anderson BO, et al: NCCN Guidelines Insights: Breast Cancer, Version 3.2018. J Natl Compr Canc Netw 17:118-126, 2019\u003c/li\u003e\n\u003cli\u003eWang J, Xiu BQ, Guo R, et al: [Current trend of breast cancer neoadjuvant treatment in China: a cross-sectional study]. Zhonghua Zhong Liu Za Zhi 42:931-936, 2020\u003c/li\u003e\n\u003cli\u003eWhitehead I, Irwin GW, Bannon F, et al: The NeST (Neoadjuvant systemic therapy in breast cancer) study: National Practice Questionnaire of United Kingdom multi-disciplinary decision making. BMC Cancer 21:90, 2021\u003c/li\u003e\n\u003cli\u003eMougalian SS, Soulos PR, Killelea BK, et al: Use of neoadjuvant chemotherapy for patients with stage I to III breast cancer in the United States. Cancer 121:2544-52, 2015\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-surgical-oncology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjso","sideBox":"Learn more about [World Journal of Surgical Oncology](http://wjso.biomedcentral.com)","snPcode":"12957","submissionUrl":"https://submission.nature.com/new-submission/12957/3","title":"World Journal of Surgical Oncology","twitterHandle":"@OncoBioMed","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"breast cancer, biopsy, frozen section, lymph node","lastPublishedDoi":"10.21203/rs.3.rs-6213557/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6213557/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eThe false-negative rate (FNR) of fine needle aspiration (FNA) for clinically positive (suspicious) lymph nodes (LNs) remains excessively high.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eWe compared the feasibility and diagnostic efficiency of using a novel procedure to FNA for the assessment of clinically positive nodes in patients with early breast cancer. Between 1 January 2015 and 30 September 2023, 198 consecutive patients who consented to undergo axillary biopsy were referred to either the intraoperative ultrasound-guided wire localization group (IOUS-wire) or the ultrasound-guided fine needle aspiration group (US-FNAC). The primary endpoint was the false-negative rate (FNR) and accuracy rates of the two methods. One hundred patients were in the IOUS-wire group, whereas the other 98 patients were in the US-FNAC group.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eThe FNR of clinically positive lymph node biopsies was lower in the IOUS-wire localization group than in the US-FNAC group (16.1% versus 87.5%, p \u0026lt;0.001). Among the 32 successful identifications, 26 were in the IOUS-wire group. A total of 42 patients with additional lymph node metastases were found among FNAC-LN-negative patients by SLNB. The accuracy rates were 95% and 57.1% (p \u0026lt;0.001). No significant differences were observed in terms of complications or the median number of SLNs harvested between the groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eCompared with preoperative FNA, intraoperative US-guided wire localization biopsy is a feasible alternative procedure for cN1 patients, especially in luminal types breast cancer. This novel method is a clinical practice in China and should be further pursued as a potential biopsy method for the evaluation of axillary node status.\u003c/p\u003e","manuscriptTitle":"Intraoperative ultrasound guided wire(IOUS-wire) localization biopsy versus preoperative fine needle aspiration cytology(FNAC) for early breast cancer with clinically positive nodes","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-06 17:54:11","doi":"10.21203/rs.3.rs-6213557/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-04-13T15:15:45+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-11T21:03:04+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-11T17:07:41+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-10T11:49:16+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"65430189198294260564979091662319454828","date":"2025-04-04T18:07:40+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-04T03:10:26+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"177029093254524987508312780256866270109","date":"2025-04-02T22:33:17+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"282884577160776345619076944552390212006","date":"2025-04-02T04:45:24+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-02T02:18:56+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"179992110568680415161897721615437360914","date":"2025-04-02T01:54:34+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-01T18:24:34+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"189533987921899568283501173743213772282","date":"2025-04-01T18:22:41+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"59102880286010589864800014930660863477","date":"2025-04-01T18:05:32+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-04-01T16:12:02+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-29T04:51:19+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-03-24T01:49:51+00:00","index":"","fulltext":""},{"type":"submitted","content":"World Journal of Surgical Oncology","date":"2025-03-12T15:49:29+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-surgical-oncology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjso","sideBox":"Learn more about [World Journal of Surgical Oncology](http://wjso.biomedcentral.com)","snPcode":"12957","submissionUrl":"https://submission.nature.com/new-submission/12957/3","title":"World Journal of Surgical Oncology","twitterHandle":"@OncoBioMed","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"0a5af7b2-52a6-4185-82e2-bfcf048c39c8","owner":[],"postedDate":"May 6th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-07-28T16:06:09+00:00","versionOfRecord":{"articleIdentity":"rs-6213557","link":"https://doi.org/10.1186/s12957-025-03925-9","journal":{"identity":"world-journal-of-surgical-oncology","isVorOnly":false,"title":"World Journal of Surgical Oncology"},"publishedOn":"2025-07-22 15:57:04","publishedOnDateReadable":"July 22nd, 2025"},"versionCreatedAt":"2025-05-06 17:54:11","video":"","vorDoi":"10.1186/s12957-025-03925-9","vorDoiUrl":"https://doi.org/10.1186/s12957-025-03925-9","workflowStages":[]},"version":"v1","identity":"rs-6213557","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6213557","identity":"rs-6213557","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}