Article Text
Abstract
Introduction/Background*Surgical lymph node staging is required in vulvar cancer in patients candidates for primary surgery. In order to complete the diagnosis and reduce the morbidity due to radical inguinal lymphadenectomy, the selective sentinel lymph node biopsy (SLNB) has been validated reporting a false negative rate of 2-6%. This technique avoids high morbidity and achieves diagnostic precision. SLNB should be the standard treatment when indicated, since it is a safe technique with less morbidity.
The tracer validated in SLNB is technetium-99m (Tc-99). In Donostia´s University Hospital (DUH), we are carrying out a study to validate the Superparamagnetic iron oxide tracer (SPIONs) in vulvar cancer compared to the currently standarized.
Methodology This is a prospective observational study at the DUH from April 2016 to the present day using a sample size of 12 patients.
Information was obtained from DUH’s database and analysed with SPSS.
Eligibility criteria to perform SLNB were squamous histology, FIGO Ib-II stage, size ≤ 4 centimeters, unifocal injury negative and clinical-radiological lymph node examination, all defined in GROINSS-V.
Subjects received both tracers, the one already validated (Tc-99) and the tracer under study (SPIONs). The sentil nodes detected were analyzed intraoperatively. If the result of the intraoperative analysis was positive or the sentil node was not detected, a radical inguinal homolateral lymphadenectomy was performed.
Result(s)*Twelve patients were included. Sentinel node detection rate was a 100%.
Two patients (16.67%) (after performing SLNS) had a positive result. The nodes with a histopathological positive result were always been elected as sentinel node. In patients with positive nodes, the rest of the accessory lymph nodes obtained from the lymphadenectomy were negative being therefore the percentage of false negatives 0.
Conclusion*SPIONs is showing not to be inferior to Technetium-99m for SLNB, with 13 sentil nodes left to reach the sample size recommended in order to complete the study.
Comparing to Technetium-99m, SPIONs has the following benefits: injection during the surgery procedure, not need to go to a nuclear medicine room previously, avoid pain caused by the injection of Technetium-99m and finally it can be used in hospitals without nuclear medicine service.