International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2025
Sentinel node mapping with carbon nanoparticles versus lymphadenectomy in early cervical cancer.
СтатьяРандомизированное исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Wang Kaili, Zhai Qingjie, Xie Ya, Tian Yanpeng, Yan Shuping, Si Lulu, Zhao Mengling, Guo Ruixia
Аннотация
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.