| Background With the development of medical technology and the change of the concept of breast cancer treatment,sentinel lymph node biopsy(SLNB)has gradually replaced the traditional axillary lymph node dissection.It has become a standard procedure for the accurate staging of the axillary lymph nodes for early breast cancer patients,and the existing evidence-based medical evidence has proved its safety and diagnostic accuracy.However,the effect of the different tracer injection sites on the detection rate of sentinel lymph nodes and the accuracy of SLNB diagnosis in breast cancer is not agreed in the existing literature,which affects the selection and decision of clinical practice.Objectives Through the analysis of the existing research evidence and the quality evaluation,the best tracer injection site was selected for the sentinel lymph node biopsy of breast cancer,and the clinical practicability and diagnostic accuracy of the tracer injection scheme were tested by clinical diagnosis test.Finally,we will discuss the controversy about injection site of tracer in sentinel lymph node biopsy of breast cancer.Methods 1.The method of systematic review was used to compare the effect of different tracer injection sites on the accuracy and the detection rate in SLNB for breast cancer patients,then selected the best tracer injection site for the SLNB.2.A clinical diagnostic test was designed by prospective cohort study to test the clinical practicability and diagnostic accuracy of the tracer injection scheme which selected by the systematic review in the sentinel lymph node biopsy of breast cancer.3.A prospective randomized controlled trial was used to compare this scheme with a multi-site combined injection scheme in the difference of diagnostic efficacy for SLNB.Results 1.In the meta-analysis,a total of 19 tests were included.There were 16 studies compared subareolar(SA)with peritumoral(PT)injection;the pooled sensitivity(SEN)was 0.92 95%CI(0.90,0.95)and 0.92 95%CI(0.89,0.94);the specificity(SPE)was 1.00 95%CI(1.00,1.00)and 1.00 95%CI(1.00,1.00);the positive likelihood ratio(+LR)was 40.64 95%CI(18.24,90.52)and 38.74 95%CI(18.88,79.51);the negative likelihood ratio(-LR)was 0.12 95%CI(0.08,0.16)and 0.11 95%CI(0.08,0.15);the diagnostic odds ratio(DOR)was 491.25 95%CI(206.47,1168.80)and 429.48 95%CI(188.55,978.24);the area under curve of ROC(AUC)was 0.976±0.012 and 0.960±0.021.The success rate of SLN imaging,SA vs.PT,OR=1.57 95%CI(1.04,2.38),P=0.03.There were 4 studies compared intradermal/subcutaneous(ID)injection with intraparenchymal(IP)injection;the pooled SEN was 0.95 95%CI(0.91,0.97)and 0.92 95%CI(0.87,0.96);the SPE was 1.00 95%CI(0.98,1.00)and 1.00 95%CI(0.98,1.00);the +LR was 99.65 95%CI(25.00,397.25)and 84.71 95%CI(21.30,336.87);the-LR was 0.08 95%CI(0.03,0.24)and 0.11 95%CI(0.06,0.21);the DOR was 1368.84 95%CI(231.36,8098.79)and 758.19 95%CI(168.51,3411.41);the AUC was 0.999±0.001 and 0.993±0.014.The success rate of SLN imaging IS vs.IP,OR=4.15 95%CI(2.00,8.59),P=0.0001.2.The diagnostic cohort studies included 75 early breast cancer patients.The methylene blue and 99 mTc labeled sodium phytate and stannous chloridetracer were injected into the intracutaneous of the areola.There were 74 patients(74/75,98.7%)were successfully identified in SLNB.We all checked out 175 SLN,the mean was 2.25±1.38,SEN=90.9%,SPE=96.2%,Ac=94.6%,PV+=90.9%,PV-=96.2%,AUC=0.932±0.041.3.The randomized controlled trial brought into 126 patients,62 cases in group A were successfully detected SLNs(62/62,100%),and 64 cases in group B(64/64,100%).We detected 152 SLNs in group A,and 154 SLNs in group B(mean: 2.45±1.67 vs.2.38±1.55,P=0.790).The diagnostic accuracy indicators between the two groups(group A vs.group B): SEN 0.955 vs.0.967;SPE 1 vs.1;Ac 0.984 vs.0.984;PV+ 1 vs.1,PV-0.976 vs.0.971;YI 0.955 vs.0.967;AUC 0.977±0.026 vs.0.984±0.019.Conclusion 1.SA compared with PT showed a higher SLN detection rate and diagnosis accuracy,and the misdiagnosis rate was lower than the latter.ID showed higher SLN detection rate and diagnosis accuracy,moreover,the misdiagnosis rate and omission diagnostic rate were all lower than IP.2.Intradermal injection of tracer in areola can accurately identify sentinel lymph nodes in breast cancer.3.Compared with the multi-site combined injection of tracer,tracer inject into intradermal tissue of the areola shows a similar SLN detection rate,the comprehensive diagnostic efficiency of the two is equal.To sum up,we think that the intradermal tissue of the areola can be selected as the only tracer injection site for the female and early breast cancer patients when the sentinel lymph node biopsy is used to determine the axillary lymph node status. |
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