Objective:This study aimed to evaluate the reliability and clinical utility of intraoperative sentinel lymph node (SN) metastasis diagnosis using the one-step nucleic acid amplification (OSNA) assay in early-stage cervical cancer by comparing its accuracy with conventional histopathological examination.Methods:A retrospective analysis was conducted on 163 patients who underwent SN biopsy at Kagoshima University Hospital between April 2014 and December 2024. This study included 50 and 113 patients in the OSNA assay and histopathological diagnosis groups, respectively. The OSNA assay quantified cytokeratin 19 (CK19) mRNA levels to determine SN metastasis. The surgical outcomes, SN metastasis detection rates, and non-SN metastasis status were compared between the two diagnostic methods.Results:The SN metastasis detection rate was significantly higher in the OSNA group (12%) than in the pathology group (3%) (p< 0.05). The OSNA assay identified only micrometastases (+) among the positive cases, whereas histopathological diagnosis detected both macrometastases and micrometastases. No non-SN metastases were observed in any of the SN-positive cases, and no significant differences were observed in the recurrence rates between the two groups.Conclusions:The OSNA assay demonstrated a higher SN metastasis detection rate than conventional pathology and demonstrated superior sensitivity in identifying micrometastases. These findings suggest that intraoperative OSNA-based SN assessment in cervical cancer could improve staging accuracy and potentially reduce the need for systematic lymphadenectomy. However, further prospective studies are warranted to confirm these findings and establish clinical guidelines.
目的:本研究旨在通过比较一步核酸扩增(OSNA)检测与常规组织病理学检查的准确性,评估其在早期宫颈癌术中前哨淋巴结(SN)转移诊断中的可靠性及临床应用价值。 方法:回顾性分析2014年4月至2024年12月期间在鹿儿岛大学医院接受前哨淋巴结活检的163例患者。其中OSNA检测组50例,组织病理学诊断组113例。OSNA检测通过量化细胞角蛋白19(CK19)mRNA水平判定前哨淋巴结转移状态。比较两种诊断方法的手术结果、前哨淋巴结转移检出率及非前哨淋巴结转移情况。 结果:OSNA组的前哨淋巴结转移检出率(12%)显著高于病理组(3%)(p<0.05)。OSNA检测在阳性病例中仅检出微转移(+),而组织病理学诊断同时检出宏转移与微转移。所有前哨淋巴结阳性病例均未发现非前哨淋巴结转移,两组复发率亦无显著差异。 结论:OSNA检测较传统病理学方法具有更高的前哨淋巴结转移检出率,在识别微转移方面展现出更优的敏感性。这些发现提示,基于OSNA的宫颈癌术中前哨淋巴结评估可提高分期准确性,并可能减少系统性淋巴结清扫的必要性。但需进一步开展前瞻性研究以验证该结果并建立临床指南。