Sentinel node mapping with carbon nanoparticles versus lymphadenectomy in early cervical cancer
To evaluate the morbidity of sentinel lymph node (SLN) biopsy with carbon nanoparticle suspension mapping compared to pelvic lymphadenectomy in patients with early-stage cervical cancer. This prospective study consecutively enrolled patients who were diagnosed pre-operatively with 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IA2 to IB1 cervical cancer with histologically confirmed squamous-cell carcinoma or adenocarcinoma. Randomization was performed before surgery, and participants were assigned to undergo a SLN biopsy with carbon nanoparticle suspension (the biopsy group) or a pelvic lymphadenectomy (the lymphadenectomy group). The primary endpoint was lymph-related morbidity, and secondary endpoints included oncologic outcomes. A total of 208 patients were randomized to the biopsy group (104 cases) and the lymphadenectomy group (104 cases). Lymph-related complications, including lower extremity lymphedema (3.8% vs 19.2%, relative risk 0.20, 95% confidence interval [CI] 0.07 to 0.57, p < .01) and pelvic lymphoceles (18.3% vs 43.3%, p < .01), were significantly reduced in the biopsy group compared to the lymphadenectomy group. The incidence of neurological complications in the biopsy group, including those occurring during the peri-operative period and at the 6-month follow-up, and the occurrence of venous thrombosis, was significantly reduced (p < .05). In addition, the biopsy group demonstrated significantly shorter operative times (p < .01), lower pelvic drainage volumes (p < .01), shorter pelvic drainage times (p < .01), and decreased post-operative hospital stays (p = .02). Oncologic outcomes were comparable in the 2 groups, with the median follow-up of 18-month disease-free survival rates of 98.2% in the biopsy group and 95.2% in the lymphadenectomy group (hazard ratio 0.51, 95% CI 0.10 to 2.55, p = .42). SLN biopsy using carbon nanoparticle suspension as a substitute for pelvic lymphadenectomy can reduce post-operative morbidity, particularly lymph-related complications, with comparable short-term oncologic safety in FIGO stage IA2 to IB1 cervical cancer.