A single-center randomization feasibility study was performed (July 2022-January 2025). Twenty patients scheduled for bilateral inguinal sentinel lymph node procedure for vulvar cancer were included and randomized for intervention order (conventional/navigation first) and allocated groin for navigation (left/right). Time to localize the sentinel lymph node was recorded. Sentinel lymph node localization failure was evaluated, and complications were recorded. Surgeon's feedback on the navigation workflow was evaluated using the System Usability Scale (score 0-100), >68 being useful.
This study showed that navigated sentinel lymph node procedure is feasible, and surgeons favor its use in challenging sentinel lymph node procedures.
Patients' mean age was 74 ± 13 years. Most tumors were International Federation of Gynecology and Obstetrics stage IB (11/20), with 1 patient with stage IA and 8 patients with stage III; histologically, 19 were squamous cell carcinoma and 1 basaloid carcinoma. For successfully localized sentinel lymph nodes, there was no statistically significant difference in median time (CI -9 to 3, p = .32) between conventional (16 min [interquartile range; 13-20, standard deviation: 9]) and navigation intervention (15 min [interquartile range; 13-25, standard deviation: 13]). In conventional interventions, in 3 of 20 cases (15%, CI 3.2 to 37.5) the sentinel lymph node was not found. The search continued with navigation and all sentinel lymph nodes were successfully removed. No intra-operative complications occurred. Navigation's usability was high scoring 79 of 100 in the System Usability Scale. Surgeons reported improved decisiveness and the need of navigation to locate sentinel lymph nodes when high body mass index (defined as ≥30 kg/m2), non-visible methylene blue or high background radioactivity.
In many countries inguinal sentinel lymph node removal is conventional for staging unifocal, macroscopic vulvar cancer <4 cm, but localization can be difficult and inguinal-femoral lymphadenectomy is associated with morbidity. This study investigates the safety and feasibility of image-guided surgical navigation for localizing inguinal sentinel lymph nodes intra-operatively.
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