Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Department of Obstetrics and Gynecology, Hallym University Sacred Heart Hospital, Anyang, Korea.
J Gynecol Oncol. 2022 Nov;33(6):e73. doi: 10.3802/jgo.2022.33.e73. Epub 2022 Jul 25.
Sentinel lymph node (SLN) mapping has been suggested as an alternative surgical technique to full lymphadenectomy for early-stage endometrial cancer. However, the survival outcomes of SLN mapping compared with lymphadenectomy have not been established via a prospective study.
A multi-center, single-blind, randomized controlled trial has been designed to determine the prognostic value of SLN mapping alone compared with conventional lymphadenectomy for patients with clinical stage I-II endometrial cancer. Eligible participants will be randomly assigned in a 1:1 ratio between the group to undergo SLN mapping using indocyanine green and the conventional lymph node dissection group. A high-risk group will undergo a 2-step SLN mapping procedure. The primary endpoint is the 3-year disease-free survival (DFS). The secondary endpoints are 3-year overall survival (OS), 5-year DFS, 5-year OS after surgery, pattern of recurrence, immediate surgical outcomes, success rate of SLN mapping, postoperative lymph-related complications, postoperative quality of life, and postoperative cost effectiveness. The role of pathologic ultrastaging of SLNs will also be assessed.
ClinicalTrials.gov Identifier (NCT number): NCT04845828.
前哨淋巴结（SLN）绘图已被提议作为早期子宫内膜癌的全淋巴结清扫术的替代手术技术。然而，通过前瞻性研究尚未确立 SLN 绘图与淋巴结清扫术相比的生存结果。
设计了一项多中心、单盲、随机对照试验，以确定 SLN 绘图单独与临床 I-II 期子宫内膜癌患者常规淋巴结清扫术相比的预后价值。合格的参与者将按照 1:1 的比例随机分配到接受吲哚菁绿 SLN 绘图和常规淋巴结解剖组的组中。高危组将进行 2 步 SLN 绘图程序。主要终点是 3 年无病生存率（DFS）。次要终点是 3 年总生存率（OS）、5 年 DFS、手术后 5 年 OS、复发模式、即刻手术结果、SLN 绘图成功率、术后淋巴相关并发症、术后生活质量和术后成本效益。还将评估 SLN 病理超分期的作用。
ClinicalTrials.gov 标识符（NCT 编号）：NCT04845828。
