[Identification and preservation of arm lymphatics in axillary lymph node dissection to prevent arm lymphedema: a single center randomized controlled trial].

Objective: To evaluate the feasibility of identification and preservation of arm lymphatics (DEPART) in axillary lymph node dissection (ALND) for breast cancer to prevent arm lymphedema. Methods: A randomized controlled study method was used. Two hundred and sixty-five patients who underwent breast cancer surgery at the Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University from November 2017 to June 2018 were included, and the patients were randomly divided into ALND+ DEPART group (132 patients) and standard ALND group (133 patients) by random number table method. In the ALND+ DEPART group, indocyanine green and methylene blue were injected as tracers before surgery, and the arm sentinel nodes was visualized by staged tracing during intraoperative dissection of axillary lymph nodes. Partial frozen sections were made of arm lymph nodes >1 cm in length and hard and suspicious of metastasis, and arm lymph nodes and lymphatic vessels were selectively preserved. Patients in the standard ALND group underwent standard ALND. Objective and subjective indexes of arm lymphedema were evaluated by 5-point circumference measurement and Norman questionnaire. Results: Among 132 breast cancer patients in the ALND+ DEPART group, 121 (91.7%) completed DEPART. There were no statistically significant differences in age, body mass index, pathological type, dissection number of axillary lymph node, N stage, TNM stage, molecular typing, and regional radiotherapy between the ALND+ DEPART and standard ALND groups (P>0.05). At a median follow-up of 24 months, assessment by the 5-point circumference measurement showed that the incidence rates of lymphedema in the ALND+ DEPART and standard ALND groups were 5.0% (6/121) and 15.8% (21/133), respectively, with statistically significant differences (P=0.005). Assessment by the Norman questionnaire showed that the incidence rates of lymphedema in the ALND+ DEPART and standard ALND groups were 5.8% (7/121) and 21.8% (29/133), respectively, with a statistically significant difference (P<0.001). No local regional recurrence was observed in either group during the follow-up period. Conclusion: For breast cancer patients with positive axillary lymph nodes, the administration of DEPART during ALND can reduce or avoid the occurrence of arm lymphedema without compromising oncology safety.目的： 评估腋窝淋巴结清扫术(ALND)中施行识别并保护上肢淋巴系统技术(DEPART)对预防或减轻乳腺癌患者术后上肢淋巴水肿的效果。 方法： 采用随机对照研究方法。纳入2017年11月至2018年6月在武汉大学中南医院甲乳外科拟行乳腺癌手术的265例患者，通过随机数字表法，将患者随机分为ALND+DEPART组(132例)和标准ALND组(133例)。ALND+DEPART组患者术前注射示踪剂吲哚菁绿和亚甲蓝，术中清扫腋窝淋巴结时，采用分级显影方法示踪上肢淋巴系统，对长径>1 cm、质硬可疑转移的上肢淋巴结做1/4部分冰冻切片，选择性保留上肢淋巴结及淋巴管。标准ALND组患者行标准ALND。术后分别采用5点周径测量体积法和Norman问卷调查，对患者的上肢淋巴水肿情况进行客观和主观指标评估。 结果： ALND+DEPART组132例乳腺癌患者中，121例(91.7 %)完成DEPART。ALND+DEPART组和标准ALND组患者的年龄、体质指数、病理类型、腋窝淋巴结清扫数目、N分期、TNM分期、分子分型、区域放疗差异均无统计学意义(均P>0.05)。中位随访24个月，5点周径测量体积法评估显示，ALND+DEPART组和标准ALND组的淋巴水肿发生率分别为5.0%(6/121)和15.8%(21/133)，差异有统计学意义(P＝0.005)。Norman问卷调查法评估显示，ALND+DEPART组和标准ALND组的淋巴水肿发生率分别为5.8%(7/121)和21.8%(29/133)，差异有统计学意义(P<0.001)。两组患者均未出现局部区域复发。 结论： 对腋窝淋巴结阳性的乳腺癌患者，ALND术中施行DEPART，能在保证肿瘤安全性的基础上，减少或避免上肢淋巴水肿的发生。.