J Gynecol Oncol.  2022 Nov;33(6):e73. 10.3802/jgo.2022.33.e73.

Randomized comparison between sentinel lymph node mapping using indocyanine green plus a fluorescent camera versus lymph node dissection in clinical stage I-II endometrial cancer: a Korean Gynecologic Oncology Group trial (KGOG2029/SELYE)

Affiliations
  • 1Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
  • 2Department of Obstetrics and Gynecology, Hallym University Sacred Heart Hospital, Anyang, Korea
  • 3Department of Pathology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 4Department of Obstetrics and Gynecology, Women’s Cancer Center, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea

Abstract

Background
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.
Methods
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.

Keyword

Endometrial Cancer; Sentinel Lymph Node; Indocyanine Green; Lymphadenectomy; Prognosis
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