Restaino Stefano, Poli Alice, Arcieri Martina, Mariuzzi Laura, Tulisso Angelica, Paparcura Federico, Pellecchia Giulia, Berretta Roberto, Capozzi Vito Andrea, Di Donato Violante, Buda Alessandro, Bogani Giorgio, Fanfani Francesco, Driul Lorenza, Orsaria Maria, Vizzielli Giuseppe
Clinic of Obstetrics and Gynecology, "Santa Maria Della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy; PhD School in Biomedical Sciences, Gender Medicine, Child and Women Health, University of Sassari, 07100, Sassari, Italy.
Clinic of Obstetrics and Gynecology, "Santa Maria Della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy; Department of Medicine, University of Udine, Udine, Italy.
Eur J Surg Oncol. 2025 Sep;51(9):110192. doi: 10.1016/j.ejso.2025.110192. Epub 2025 May 31.
The one-step nucleic acid amplification (OSNA) method has emerged as a potential alternative to ultrastaging for diagnosing lymph node metastasis. This study aims to assess the cost-effectiveness of the OSNA technique compared to ultrastaging for detecting SLN metastasis in patients with early-stage endometrial cancer (EC).
This retrospective, observational, single-center study included 30 patients with EC who underwent surgical treatment. SLN mapping was performed using an intracervical injection of indocyanine green. SLNs were analyzed and classified as negative, as having isolated tumor cells, micrometastases, or macrometastases. The study evaluated and quantified the costs of the OSNA and ultrastaging procedures in euros.
A total of 54 lymph nodes were analyzed using both the OSNA and ultrastaging methods. Concordant negativity was identified in 48 cases (89 %), while micrometastases were detected concordantly in 1 case (1.8 %). The cost for a single ultrastaging lymph node analysis, including immunohistochemistry, is approximately € 250, with a total processing time of 2 days. The cost for a single OSNA analysis is approximately € 236, boasting a significantly shorter processing time of 30-40 min. While materials and staff costs are comparable between both techniques, considering time-related expenses, the OSNA method proves to be more cost-effective than ultrastaging (p < 0.001).
The OSNA method demonstrates diagnostic accuracy comparable to histopathological examination in detecting lymph node metastases, reinforcing its reliability for lymph node assessment in patients with EC. Our cost analysis reveals that the OSNA method is more cost-effective than ultrastaging when time-related expenses are considered.
一步核酸扩增（OSNA）方法已成为诊断淋巴结转移的超分期潜在替代方法。本研究旨在评估OSNA技术与超分期在检测早期子宫内膜癌（EC）患者前哨淋巴结转移方面的成本效益。
这项回顾性、观察性、单中心研究纳入了30例行手术治疗的EC患者。通过宫颈内注射吲哚菁绿进行前哨淋巴结定位。对前哨淋巴结进行分析并分类为阴性、有孤立肿瘤细胞、微转移或大转移。本研究以欧元评估并量化了OSNA和超分期程序的成本。
共使用OSNA和超分期方法分析了54个淋巴结。48例（89%）结果一致为阴性，1例（1.8%）结果一致检测到微转移。单次超分期淋巴结分析（包括免疫组织化学）的成本约为250欧元，总处理时间为2天。单次OSNA分析的成本约为236欧元，处理时间显著更短，为30 - 40分钟。虽然两种技术的材料和人员成本相当，但考虑到与时间相关的费用，OSNA方法比超分期更具成本效益（p < 0.001）。
OSNA方法在检测淋巴结转移方面显示出与组织病理学检查相当的诊断准确性，增强了其在EC患者淋巴结评估中的可靠性。我们的成本分析表明，考虑到与时间相关的费用时，OSNA方法比超分期更具成本效益。
