| Background and Objective:Patients diagnosed as early breast cancer are mainly treated by surgery.In clinical evaluation,patients without axillary lymph node metastasis often undergo sentinel lymph node(SLN)biopsy(SLNB).Correct SLNB tracing is critical to accurate axillary staging,which will directly determine the overall treatment decision of patients.Currently,methylene blue is mainly used for SLNB in clinical practice.Methylene blue is a commonly used dye tracer in China,with good intraoperative visibility.Methylene blue tracing SLN can only be performed during surgery by probed along the blue-stained lymphatic vessels leading to blue-stained lymph nodes,therefore increasing the operation time.B-scan ultrasound is a simple imaging method that not only provides information about the anatomical position,shape,size,and other information of axillary lymph nodes,but also performs surface positioning and labeling of the first lymph node.Therefore,we believe that ultrasonic localization may play a helpful role in methylene blue SLNB in clinical practice.We speculate that methylene blue combined with ultrasonic localization can reduce the exploration time of SLNs,shorten the operation time of SLNB,and improve the efficiency of lymph node biopsy.We hope that through this prospective randomized controlled study,early breast cancer patients who have not received new adjuvant treatment and who plan to undergo SLNB will be included in the study,and reasonable grouping and design will be carried out.Finally,conclusions will be drawn to verify our hypothesis,which will provide an important basis for SLNB with methylene blue combined with ultrasonic localization,and promote its clinical application.Methods:Criteria for inclusion of patients:(1)breast cancer patients with clinical stage c Tis-T2N0,(2)not receiving neoadjuvant therapy,(3)having an indication for SLNB without contraindications,and(4)no prior axillary surgery.The enrolled patients were randomly assigned according to 1:1 and were divided into study group and control group.Record the number of lymph nodes in SLNB and the time required for surgery.The statistical method of t-test was used to analyze the difference between the average number of detections and mean time of biopsy operation between the two groups.This study was proved by the institutional review boards.Written inform consent was obtained from all enrolled patients.Results:A total of 356 breast cancer patients treated in Shenzhen Maternity and Child Healthcare Hospital from January 2019 to December 2022 were randomly assigned to study group(117 cases)or control group(119 cases).There were no differences between the two groups in terms of age,T-stage,tumor location,tumor pathological type,molecular type,and body mass index(BMI)(P > 0.05).The recognition rate of SLN was 94.4% in the study group and 93.9% in the control group.There were no statistical significant differences in the rate of lymph node metastasis between the two groups(15.6% vs 12.5%;P = 0.419),there were no significant differences in the number of SLNs between the two groups(2.53 ± 1.24 vs 2.38 ± 1.28;P = 0.251).The mean operation time(17.09 ± 11.85 min)in the study group was statistically significantly shorter than that in the control group(26.84 ± 13.71 min)(P < 0.001).In the subgroup analysis,the average operation time of "large incision" SLNB in the study group(27.23 ± 11.42 min)was significantly shorter than that in the control group(37.31 ± 12.13 min),(P < 0.001).The average operation time of "small incision" SLNB in the study group(11.10 ± 7.08 min)was statistically significantly shorter than that in the control group(20.39 ±10.23 min),(P < 0.001).There are 1-3lymph nodes closest to the breast marked by preoperative B-scan ultrasound.In the SLN successfully blue-stained by methylene blue combined with ultrasonic localization group,the number,size and shape of blue-stained lymph nodes were checked during the operation,and it was found that the lymph nodes located by B-scan ultrasound before the operation were blue-stained.Conclusion:In the sentinel lymph node biopsy of early breast cancer,methylene blue combined with ultrasonic localization significantly shortened the operation time and improved the biopsy efficiency compared with the methylene blue tracing method.The "first station" lymph nodes closest to the breast were consistent with the blue-stained sentinel lymph nodes.The axillary "small incision" had the advantages of shortening the operation time,avoiding blind exploration of sentinel lymph nodes,and reducing trauma.In this study,ultrasound body surface localization of lymph nodes technology has the characteristics of simple,easy to learn,non-invasive,and low-cost.Its application in methylene blue tracing SLNB can improve surgical efficiency.The combination of the two has high clinical significance and application value. |
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