The Clinical Analysis Of Sentinel Lymph Node Biopsy Traced By Combination Of Indocyanine Green Fluorescence And Methylene Blue For Patients With Early-stage Breast Cancer

ObjectiveTo compare the clinical efficacy of tracing sentinel lymph node biopsy(SLNB)between methylene blue only and combination of indocyanine green fluorescence and methylene blue.MethodsTwo hundred and twenty-one patients performing sentinel lymph node biopsy were divided into two groups:SLNs traced by methylene blue only(118 patients)and traced by combination of indocyanine green fluorescence and methylene blue(106 patients)according to the two different ways to identify SLNs.Selection criteria included:(1)breast cancer of stage Ⅰ or Ⅱ according to AJCC;(2)single primary tumor;(3)without clinical regional axillary lymph node metastasis or distant metastasis;(4)no history of surgery,neoadjuvant chemotherapy,endocrine therapy or radiotherapy on the lpsilateral breast or armpit;(5)patients’ agreement.After making a definitive diagnosis for breast cancer by pathological results of percutaneous biopsies,we injected methylene blue in areola or peritumoral area subcutaneously at 15 minutes before surgery.And then dilute indocyanine green fluorescence by ten times was added to outer upper quadrant of mammary areola subcutaneously for combination groups.Thus we can found lymph vessels stained by fluorescence in the help of fluorescent vascular imaging device and then marked the spot in the skin where fluorescence disappeared.The skin and subcutaneous tissues were incised,then lymph nodes stained by indocyanine green fluorescence were found.For the group of lymph nodes only stained by methylene blue,lymph nodes stained blue were localized accurately after identification of blue-stained lymphatic vessels.Identified SLNs of combination groups included both blue-stained lymph nodes and fluorescence-stained lymph nodes,whereas for only methylene blue groups,SLNs just dyed blue.Based on the results of frozen sections for SLNs,we chose axllary lymph node dissection(ALND)if SLNs of anyone was positive or Level I andⅡ axllary lymph nodes were dissected.Both SLNs and axillary lymph nodes were performed for standard pathological examination later,respectively.After comparison of the results of pathological examination between SLNs and axllary lymph nodes,several indexes such as identification rate,identification numbers,false negative rate,sensitivity and specificity were used for further study.The clinical efficacy of SLNB traced by combination of indocyanine green fluorescence and methylene blue were evaluated by using the above indicators.The relationship between number of SLNs and false negative rate could be further investigated through pathological examination.Results1.No complications associated with tracer occurred in both 106 patients for combination group and 118 patients for methylene blue group.Besides,the difference of general condition between the two groups had no statistical significance(P>0.05).So does the postoperative pathological condition.2.90.68%SLNB using methylene blue was successfully performed(107/118),while the other group was 98.11%(104/106).Among the combination group,identification rate was 95.28%(101/106)which was in contrast to the rate of 93.40%(99/106)for methylene blue group.A median of 2(range from 1 to 4)SLNs were excised in methylene blue group and the median in combination group was 3(range from 1 to 7).3.According to pathological examination results of SLNs and axillary lymph node,patients with missed diagnosis were 6 in methylene blue group and 4 in combination group.Thus,for methylene blue group,false negative rate was 11.76%,sensitivity was 88.24%and specificity was 85.98%.While for combination group,false negative rate was 7.69%with sensitivity of 92.30%and specificity of 86.54%similarly.4.There were 104 patients incising SLNs with no more than two and other 107 patients had SLNs incised with more than three.The false negative rate was 3.45%when SLNs were more than three and 17.78%for SLNs with no more than two.Conclusion1.Sentinel lymph node biopsy traced by combination of indocyanine green fluorescence and methylene blue for patients with early-stage breast cancer was higher in identification rate and was lower in false negative rate than methylene blue staining only.2.The combination tracing method is simple and safe.So,sentinel lymph node biopsy traced by combination of indocyanine green fluorescence and methylene blue in early-stage breast cancer patients have great clinical application prospects.