Article Text
Abstract
Introduction/Background Systematic pelvic and para-aortic lymphadenectomy is part of the staging surgery in early-stage ovarian cancer (EOC) to determine the prognosis and indicate adjuvant treatment. However, this procedure is associated with potential severe morbidity. The Mapping Sentinel Lymph Node In early-Stage Ovarian Cancer (MELISA) trial aims to evaluate the sentinel lymph node (SLN) detection and diagnostic accuracy of SLN technique in patients who underwent complete pelvic and paraortic lymphadenectomy in early-stage EOC.
Methodology Patients with ovarian masses suspected of malignancy or re-staging surgery after confirmed malignancy were included. Before the removal of the adnexal tumor, a radiotracer was injected to the infundibulo-pelvic and utero-ovarian ligament. Subsequently, intraoperative images were acquired with a portable gammacamera. After 15 minutes, the adnexal tumor was removed and sent for frozen section assessment. Once malignancy was confirmed, indocyanine green (ICG) was injected to the infundibulo-pelvic and utero-ovarian ligament stumps. The SLN detection was guided by the gammadetector probe, gammacamera and near Infra-red camera. Ultrastaging of the SLN was performed.
Results Sixty-two patients were considered eligible between January-2021 and April-2022. Finally, 30 patients with EOC were analyzed. No statistical differences were found in the baseline and surgical characteristics when categorized according to SLN detection outcomes. In 90% (27/30 patients) at least one SLN was detected, being 88.89% (16/18) in primary surgery and 91.67% (11/12) in re-staging surgeries (p > 0.999). In 96.30% (26/27), 48.15% (13/27) and 44.44% (12/27) the SLN was detected in the aortic, pelvic or both regions, respectively. SLN metastases were found in 18.52% (5/27) with false negative rate of 0% (95% CI 0 – 43.4) and negative predictive value(NVP) of 100% (95% CI 85.1 – 100). Only low volume SLN metastasis were found.
Conclusion The SLN detection rate in EOC has a high overall detection rate with a NPV of 100% when injecting both radiotracer and ICG
Disclosures .