腹腔镜吲哚菁绿荧光显影指引淋巴结切除用于早期子宫内膜癌分期手术的临床研究

Study on laparoscopic lymphadenectomy guided by lymphatic mapping with indocyanine green fluorescent dye in staging surgery for women with early-stage endometrial carcinoma

目的探讨腹腔镜吲哚菁绿荧光显影技术对子宫内膜癌患者腹膜后淋巴结转移状态的预测价值,及其用于指引早期子宫内膜癌患者分期手术中淋巴结切除的可行性。方法选取2017年7月1日至2018年6月30日在佛山市第一人民医院肿瘤妇科行腹腔镜全面分期手术的临床早期子宫内膜癌患者37例,手术开始前于宫颈注射吲哚菁绿,国产欧谱曼迪荧光腹腔镜系统(opto-cam2100)采集淋巴显影图后系统性切除盆腔及腹主动脉旁淋巴结达左肾静脉水平,术后将显影和非显影淋巴结分别标示送检。以术后病理学检查结果作为金标准,分析荧光显影对于淋巴结转移状态的预测价值,并采用logistic回归分析显影效果的影响因素。结果 37例患者中显影成功34例,显影率为91.9%。其中仅盆腔淋巴结显影22例,盆腔及腹主动脉旁淋巴结均显影11例,仅腹主动脉旁区域显影者1例,盆腔及腹主动脉旁区域显影率分别为89.2%(33/37)和32.4%(12/37)。多因素logistic回归分析显示,注射经验(≤10例vs.>10例)为显影效果的独立影响因素(P=0.041,95%CI 1.082~59.135),而体重指数、肌层浸润深度、肿瘤分化程度、患者年龄等对显影效果的影响差异无统计学意义(P>0.05)。34例显影病例中,根据显影淋巴结肿瘤转移状态预测患者淋巴结转移状态的灵敏度为85.7%,假阴性率为14.3%,阴性预测值和准确率为96.4%、97.1%。28例多区域显影者中,根据显影淋巴结肿瘤转移状态预测患者淋巴结转移状态的灵敏度、阴性预测值和准确度均为100%,假阴性率为0。结论吲哚菁绿荧光显影在临床早期子宫内膜癌患者中的应用是安全、有效和可行的。显影淋巴结对于患者腹膜后淋巴结是否存在肿瘤转移具有较好的预测价值。吲哚菁绿荧光显影指引下选择性淋巴结切除在早期子宫内膜癌患者分期手术中的价值值得深入研究。

Objective To explore the feasibility of laparoscopic lymphadenectomy guided by lymphatic mapping with indocyanine green（ICG）fluorescence in staging surgery for women with early-stage endometrial carcinoma,and the predictive value of green stained lymph nodes in assessing the patient＇s lymphatic metastasis.Methods A total of 37 women with early-stage endometrial carcinoma were enrolled in this study,who underwent laparoscopic complete staging surgery in the First People＇s Hospital of Foshan,China from July 1,2017 to June 30,2018.ICG was injected into the cervix of each patient,followed by laparoscopic systematic pelvic and para-aortic lymphadenectomy up to renal vein level using the opto-cam 2100 near-infrared fluorescence imaging system（OptoMedic,Foshan,China）.The mapped and nonmapped lymph nodes were sent for detection respectively.All the excised lymph nodes were diagnosed by routine pathological examination as golden standard.The predictive value of green stained lymph nodes for assessing the patient＇s lymphatic metastasis was analyzed,and the influencing factors of lymphatic mapping were analyzed by univariate and multivariate logistic regression analysis respectively.Results Of these 37 patients,34 patients had successful mapping and the detection rate was 91.9%.Among them,22 cases were successful in pelvic lymphatic mapping in pelvic only,11 cases were pelvic and para-aortic lymphatic mapping,and 1 case was para-aortic lymphatic mapping only.The rate of pelvic and para-aortic area mapping was 89.2%and 32.4%,respectively.The result of multi-variate logistic regression analysis showed that ICG injection experience（≤10 cases vs.10 cases）was the independent influencing factor of mapping effect（P=0.041,95% CI 1.082-59.135）,while the influencing value of BMI,depth of myometrial invasion,grade of tumor differentiation,and age of patients were not significant.Among the 34 patients with lymphatic successful mapping,it was valuable to predict the metastatic state in those non-imaged lymph nodes according to the metastatic state of those imaged lymph nodes.The sensitivity,false negative rate,negative predictive value and accuracy rate were 85.7%,14.3%,96.4% and 97.1% respectively.In those 28 patients with multi-area positive fluorescence imaging,all of the sensitivity,negative predictive value and accuracy rate were 100% and the false negative rate was 0.Conclusion ICG near-infrared fluorescent lymphatic mapping is safe,effective and feasible in laparoscopic staging-surgery for patients with early endometrial carcinoma.The fluorescent imaged lymph nodes is valuable in predicting the metastasis of retroperitoneal lymph nodes.Selective lymphadenectomy in patients with early-stage endometrial carcinoma guided by ICG fluorescent lymphatic mapping is worthy of further study.