Intraoperative Ultrasound Guidance For Excision Of Palpable Breast Cancer In Breast-conserving Surgery

Background:Breast-Conserving Surgery becomes a regular operation method for early stage breast cancer,palpation guidance has been used to the resection of palpable breast cancer in Breast-Conserving Surgery,but it is not a perfect method.The palpation guidance leaded to the overmuch excision of normal mammary tissue,and high rate of the first positive margin,and so on.So it is important and urgent to find another better method.Objective:The aim of this study was to compare the advantages of the Intraoperative Ultrasound Guidance?IUG?for palpable breast cancer to the palpation guidance for palpable breast cancer,to provide a better method for surgeons in palpable breast cancer in Breast-Conserving Surgery.Methods:In this prospective randomised controlled clinical trial,61 women who had been diagnosed with palpable early-stage(T_1-2N_0-1)primary invasive breast cancer and deemed suitable for breast-conserving surgery would be randomised into Intraoperative Ultrasound Guidance?n=32?and Intraoperative Palpation Guidance?n=29?.In both groups,the tumor boundary and the excision border which was 1centimeter distance from tumor boundary were marked with the ultrasound.The US was performed in all direction for the duration of operation in the IUG group,and the palpation was used with the skin marker marked before operation in the IPG group.The length,width and height of the tumor and specimen were all measured and analysed.The margins in all orientations were measured,and no ink was stained as negative margin on a tumor under the microscope,a reexcision would be needed in positive margin,we remarked the longest margin and the shortest margin for every specimen.The patients were evaluated for cosmetic results after 3 and 6 months.The data analysis were done after collected,we calculated the CRR,the rate of positive margin and the accuracy of the removal margin,and compared the cosmetic results.Results:The median age,BMI,location of tumor and tumor stage were similar?p>0.05?,the patient and tumor characteristics were equally distributed between the IUG group and IPG group,thus avoiding selection bias.The tumor size was 1.51±1.68cm³ and 2.11±2.61 cm³ in groups IUG and IPG,respectively,this difference was not statistically significant?p=0.287?.The excision volume was 20.31±11.99cm³ in group IUG and 35.55±32.27 cm³ in group IPG;this difference was statistically significant?p=0.022?,and the CRR was 1.01±0.41 and 1.62±1.15 in groups IUG and IPG,respectively,this difference was also statistically significant?p=0.01?.The rate of positive surgical margins was 6.2%and 24.1%in groups IUG and IPG,respectively,this difference was statistically significant?p=0.049?.The longest surgical margin was1.4±0.34cm and 1.98±0.85cm in groups IUG and IPG,respectively,this difference was statistically significant?p=0.001?,and the distance with the ideal margin was0.45±0.27cm and 1.04±0.78cm in groups IUG and IPG,respectively,this difference was also statistically significant?p<0.001?.The shortest surgical margin was 0.61±0.26cm and 0.42±0.38cm in groups IUG and IPG,respectively,this difference was statistically significant?p=0.028?,and the distance with the ideal margin was 0.41±0.22cm and0.63±0.28cm in groups IUG and IPG,respectively,this difference was also statistically significant?p=0.001?.The result of cosmetic evaluation:2 patients in IUG group were poor,one patient was because of the scar and another patient was for the nipple deviation;6 patients in IPG group were poor,one patient was for the nipple deviation,four patients were due to local dent and the other one was because of the infection after surgery.This difference was not statistically significant?p=0.095?.Conclusions:1.Compare to the IPG,IUG is a method that can decrease the sacrifice of the normal mammary tissue,simultaneously ensure the clear excision of tumor.2.The rate of first positive surgical margins in the IUG group is lower than in the IPG group,at the same time,IUG can decrease the reexcision rate of the margins;the accuracy and stability for margin excision in the IUG group is higher than in the IPG group.3.There is no statistically significant difference between two groups in cosmetic evaluation,even there is less patients evaluated poor in IUG group than in IPG group.