RESUMEN
OBJECTIVE: To evaluate the clinical diagnostic validity of carbon nanoparticle suspension (CNS) in sentinel lymph node biopsy (SLNB) for assessing lymphatic spread of early-stage cervical cancer. DESIGN: A prospective study. SETTING AND POPULATION: 356 cases. METHODS: We enrolled 356 stage Ia2-IIa2 cervical cancer patients to undergo SLNB using CNS, followed by systematic pelvic lymphadenectomy. All lymph node specimens were assessed using conventional histopathologic ± pathologic ultrastaging analyses. MAIN OUTCOME MEASURES: Sentinel lymph node detection rate (DR), clinical diagnostic validity and various related factors were analysed. RESULTS: CNS identified 1456 SLNs in 325 patients. The overall SLN DR was 91.29%. A significantly higher DR was found for patients with tumours <20 mm (97.75% versus 71.91%; P < 0.001). Two patients had false-negative results. SLNB with CNS had sensitivity of 96.65%, false-negative rate (FNR) of 4.35% and negative predictive value (NPV) of 99.29%. Importantly, sensitivity (100%), NPV (100%) and FNR (0%) were improved when testing the subgroup of patients with tumours <20 mm (267 cases). There were no observed differences in DR based on pathological type or grade, stage, depth of stromal invasion, surgical approach, menopausal status or prior treatment with chemotherapy (P > 0.05). CONCLUSIONS: Sentinel lymph node biopsy with CNS results in favourable DR, sensitivity and NPV for women with early-stage cervical cancer with small tumour sizes. SLNB with CNS is safe, feasible and relatively effective for guiding precise surgical treatment of early-stage cervical cancer. TWEETABLE ABSTRACT: Sentinel lymph node biopsy with carbon nanoparticle suspension is safe and feasible for early-stage cervical cancer.