Abstract：
A single center prospective non-randomized study to assess a systematically developed anatomically-based sentinel lymph node (SLN) algorithm in cervical cancer.
Consecutive women with FIGO 2009 stage 1A2-2A1 cervical cancer undergoing robotic radical hysterectomy/trachelectomy between September 2014 and January 2023 had cervically injected Indocyanine Green (ICG) as a tracer for detection of pelvic SLN. An anatomically based surgical algorithm was adhered to; defining SLNs as the juxtauterine mapped nodes within the upper and lower paracervical lymphatic pathways including separate removal of the parauterine lymphovascular tissue (PULT). A completion pelvic lymphadenectomy was performed. Ultrastaging and immunohistochemistry was performed on SLNs, including the PULT.
181 women were included for analysis. Median histologic tumor size was 14.0 mm (range 2-80 mm). The bilateral mapping rate was 98.3%. As per protocol an interim analysis rejected H0 and inclusion stopped at 29 node positive women, all identified by at least one metastatic ICG-defined SLN. One woman awaiting histology at study-closure was node positive and included in the analysis. Sensitivity was 100% (95% CI, 88.4%-100%) and NPV 100% (95% CI, 97.6%-100%). In node positive women, the proximal obturator position harbored 46.1% of all SLN metastases representing the only position in 40% and 10% had isolated metastases in the PULT.
Strictly adhering to an anatomically based SLN-algorithm including identification of parallell lymphatics within major pathways, partilularly the obturator compartment, assessment of the PULT, restricting nodal dissection to the removal of SLNs accurately identifies pelvic nodal metastatic disease in early-stage cervical cancer.
Consecutive women with FIGO 2009 stage 1A2-2A1 cervical cancer undergoing robotic radical hysterectomy/trachelectomy between September 2014 and January 2023 had cervically injected Indocyanine Green (ICG) as a tracer for detection of pelvic SLN. An anatomically based surgical algorithm was adhered to; defining SLNs as the juxtauterine mapped nodes within the upper and lower paracervical lymphatic pathways including separate removal of the parauterine lymphovascular tissue (PULT). A completion pelvic lymphadenectomy was performed. Ultrastaging and immunohistochemistry was performed on SLNs, including the PULT.
181 women were included for analysis. Median histologic tumor size was 14.0 mm (range 2-80 mm). The bilateral mapping rate was 98.3%. As per protocol an interim analysis rejected H0 and inclusion stopped at 29 node positive women, all identified by at least one metastatic ICG-defined SLN. One woman awaiting histology at study-closure was node positive and included in the analysis. Sensitivity was 100% (95% CI, 88.4%-100%) and NPV 100% (95% CI, 97.6%-100%). In node positive women, the proximal obturator position harbored 46.1% of all SLN metastases representing the only position in 40% and 10% had isolated metastases in the PULT.
Strictly adhering to an anatomically based SLN-algorithm including identification of parallell lymphatics within major pathways, partilularly the obturator compartment, assessment of the PULT, restricting nodal dissection to the removal of SLNs accurately identifies pelvic nodal metastatic disease in early-stage cervical cancer.
摘要：
目的：一项单中心前瞻性非随机研究，旨在评估宫颈癌中系统开发的基于解剖学的前哨淋巴结（SLN）算法。
方法：2014年9月至2023年1月期间接受机器人根治性子宫切除术/子宫切除术的FIGO2009期1A2-2A1宫颈癌连续女性宫颈注射吲哚菁绿（ICG）作为检测盆腔SLN的示踪剂。坚持基于解剖学的手术算法；将SLN定义为上，下子宫颈旁淋巴通路内的子宫旁映射节点，包括单独切除子宫旁淋巴管组织（PULT）。完成盆腔淋巴结清扫术。对SLN进行超稳定和免疫组织化学，包括PULT。
结果：181名女性被纳入分析。中位组织学肿瘤大小为14.0mm（范围2-80mm）。双侧作图率为98.3%。根据方案，中期分析拒绝了H0，并在29名淋巴结阳性女性中停止了纳入，全部通过至少一个转移性ICG定义的SLN鉴定。一名在研究结束时等待组织学检查的妇女为淋巴结阳性，并包括在分析中。敏感性为100％（95％CI，88.4％-100％）和NPV100％（95％CI，97.6％-100％）。在节点积极的女性中，闭孔位置有所有SLN转移的46.1％，占40％和10％的位置在PULT中有孤立的转移。
结论：严格遵守基于解剖学的SLN算法，包括识别主要途径内的平行淋巴管，局部封闭隔室，对PULT的评估，将淋巴结清扫术限制为SLN的切除,可准确识别早期宫颈癌的盆腔淋巴结转移疾病.
方法：2014年9月至2023年1月期间接受机器人根治性子宫切除术/子宫切除术的FIGO2009期1A2-2A1宫颈癌连续女性宫颈注射吲哚菁绿（ICG）作为检测盆腔SLN的示踪剂。坚持基于解剖学的手术算法；将SLN定义为上，下子宫颈旁淋巴通路内的子宫旁映射节点，包括单独切除子宫旁淋巴管组织（PULT）。完成盆腔淋巴结清扫术。对SLN进行超稳定和免疫组织化学，包括PULT。
结果：181名女性被纳入分析。中位组织学肿瘤大小为14.0mm（范围2-80mm）。双侧作图率为98.3%。根据方案，中期分析拒绝了H0，并在29名淋巴结阳性女性中停止了纳入，全部通过至少一个转移性ICG定义的SLN鉴定。一名在研究结束时等待组织学检查的妇女为淋巴结阳性，并包括在分析中。敏感性为100％（95％CI，88.4％-100％）和NPV100％（95％CI，97.6％-100％）。在节点积极的女性中，闭孔位置有所有SLN转移的46.1％，占40％和10％的位置在PULT中有孤立的转移。
结论：严格遵守基于解剖学的SLN算法，包括识别主要途径内的平行淋巴管，局部封闭隔室，对PULT的评估，将淋巴结清扫术限制为SLN的切除,可准确识别早期宫颈癌的盆腔淋巴结转移疾病.
