Introduction Sentinel-lymph node biopsy has safely replaced lymphadenectomy in the staging of many solid cancers. The aim of this study was to evaluate the sensitivity and specificity of sentinel-lymph-node mapping compared with the gold standard of complete lymphadenectomy in detecting metastatic disease for early stage ovarian cancer.

Methods In the SELLY multicentre, prospective, phase II trial (EUDRACT 2019–001088-58) patients with presumed stage I-II epithelial ovarian cancer and planned for immediate or delayed minimally-invasive comprehensive staging were eligible for study inclusion. Patients received an injection of indocyanine green and sentinel-lymph-node mapping followed by pelvic and para-aortic lymphadenectomy. Seven centers from in Italy participated in the trial. Negative sentinel lymph nodes (by haematoxylin and eosin staining on sections) were ultra-staged with immunohistochemistry for cytokeratin. The primary endpoint, sensitivity of the sentinel-lymph-node-based detection of metastatic disease, was defined as the proportion of patients with node-positive disease with successful sentinel-lymph-node mapping who had metastatic disease correctly identified in the sentinel lymph node.

Current Trial Status Between March 2018 and July 2022, 176 patients were enrolled but only 174 received complete study interventions. 100 (58%) patients had successful mapping of at least one sentinel lymph node and 15 of them (15.0%) had positive nodes. Of the latter, 11 of 15 (73.3%) patients had a correct identification of the disease in the SLN. In detail, 7 out of 11 patients required ultrastaging protocol. 4 patients with node-positive disease had a negative SLN. Enrollment was closed on January 2023. Data analysis is about to be completed.