Togami Shinichi, Furuzono Nozomi, Mizuno Mika, Kobayashi Hiroaki
Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima 890-8520, Japan.
Medicina (Kaunas). 2025 Jul 4;61(7):1221. doi: 10.3390/medicina61071221.
: The aim of this prospective study was to evaluate the diagnostic accuracy of the one-step nucleic acid amplification (OSNA) assay for the intraoperative assessment of sentinel lymph node (SN) metastases, including micrometastases in patients with stage IA low-grade endometrial cancer. : A prospective analysis was conducted on 204 patients with low-risk endometrial cancer who underwent hysterectomy, bilateral salpingo-oophorectomy, and sentinel node navigation surgery. SNs were analyzed intraoperatively using the OSNA assay, and positive patients underwent systematic pelvic lymphadenectomy. : Among the 204 patients included, SN metastases were identified in 12 patients (6%), including 10 patients with micrometastases and 2 patients with macrometastases. No metastases were detected in non-SNs in any of the 12 patients. Recurrence occurred in two patients (1%), involving the vaginal stump and pelvic cavity dissemination, but no lymph node recurrence was observed. The OSNA assay identified a proportion of micrometastases in low-risk endometrial cancer. While a direct comparison with conventional pathological ultra-staging was not performed in this study, the detection rate of micrometastases appears higher than that reported in historical controls. : This is the first prospective study to evaluate the intraoperative use of the OSNA assay for whole SNs in endometrial cancer. The results suggest that the OSNA assay enhances the detection of micrometastases, enabling a more accurate assessment of SN metastases. In low-risk endometrial cancer, systematic pelvic lymphadenectomy may be safely omitted in patients with SN-positive micrometastases. Further prospective studies are necessary to validate these findings and support the adoption of this approach in clinical practice.
本前瞻性研究的目的是评估一步核酸扩增（OSNA）检测法对前哨淋巴结（SN）转移（包括IA期低级别子宫内膜癌患者的微转移）进行术中评估的诊断准确性。
对204例接受子宫切除术、双侧输卵管卵巢切除术和前哨淋巴结导航手术的低风险子宫内膜癌患者进行了前瞻性分析。术中使用OSNA检测法对前哨淋巴结进行分析，阳性患者接受系统性盆腔淋巴结清扫术。
在纳入的204例患者中，12例（6%）发现前哨淋巴结转移，其中10例为微转移，2例为宏转移。12例患者的非前哨淋巴结均未检测到转移。2例患者（1%）出现复发，累及阴道残端和盆腔播散，但未观察到淋巴结复发。OSNA检测法识别出了一部分低风险子宫内膜癌中的微转移。虽然本研究未与传统病理超分期进行直接比较，但微转移的检出率似乎高于历史对照报道的检出率。
这是第一项评估OSNA检测法在子宫内膜癌术中对整个前哨淋巴结应用的前瞻性研究。结果表明，OSNA检测法提高了微转移的检出率，能够更准确地评估前哨淋巴结转移。在低风险子宫内膜癌中，前哨淋巴结微转移阳性的患者可能可安全地省略系统性盆腔淋巴结清扫术。需要进一步的前瞻性研究来验证这些发现，并支持在临床实践中采用这种方法。
