医学
子宫内膜癌
淋巴结切除术
前哨淋巴结
随机对照试验
淋巴结
哨兵节点
解剖(医学)
子宫切除术
肿瘤科
放射科
癌症
外科
乳腺癌
内科学
作者
Glauco Baiocchi,Carlos Andrade,Reitan Ribeiro,Renato Moretti-Marques,Audrey Tieko Tsunoda,Vanessa Alvarenga-Bezerra,Andre Lopes,Ronaldo Costa,Lillian Yuri Kumagai,Levon Badiglian-Filho,Carlos Chaves Faloppa,Henrique Mantoan,Louise De Brot,Ricardo dos Reis,Bruna Tirapelli Gonçalves
出处
期刊:International Journal of Gynecological Cancer
[BMJ]
日期:2022-03-02
卷期号:32 (5): 676-679
被引量:11
标识
DOI:10.1136/ijgc-2022-003378
摘要
Growing evidence suggest that sentinel lymph node (SLN) biopsy in endometrial cancer accurately detects lymph node metastasis. However, prospective randomized trials addressing the oncological outcomes of SLN biopsy in endometrial cancer without lymphadenectomy are lacking.The present study aims to confirm that SLN biopsy without systematic node dissection does not negatively impact oncological outcomes.We hypothesized that there is no survival benefit in adding systematic lymphadenectomy to sentinel node mapping for endometrial cancer staging. Additionally, we aim to evaluate morbidity and impact in quality of life (QoL) after forgoing systematic lymphadenectomy.This is a collaborative, multicenter, open-label, non-inferiority, randomized trial. After total hysterectomy, bilateral salpingo-oophorectomy and SLN biopsy, patients will be randomized (1:1) into: (a) no further lymph node dissection or (b) systematic pelvic and para-aortic lymphadenectomy.Inclusion criteria are patients with high-grade histologies (endometrioid G3, serous, clear cell, and carcinosarcoma), endometrioid G1 or G2 with imaging concerning for myometrial invasion of ≥50% or cervical invasion, clinically suitable to undergo systematic lymphadenectomy.The primary objective is to compare 3-year disease-free survival and the secondary objectives are 5-year overall survival, morbidity, incidence of lower limb lymphedema, and QoL after SLN mapping ± systematic lymphadenectomy in high-intermediate and high-risk endometrial cancer.178 participants will be randomized in this study with an estimated date for completing accrual of December 2024 and presenting results in 2027.NCT03366051.
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