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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)

Authors
 Jeong-Yeol Park  ;  Ju-Hyun Kim  ;  Min-Hyun Baek  ;  Eunhyang Park  ;  Sang Wun Kim 
Citation
 JOURNAL OF GYNECOLOGIC ONCOLOGY, Vol.33(6) : e73, 2022-11 
Journal Title
JOURNAL OF GYNECOLOGIC ONCOLOGY
ISSN
 2005-0380 
Issue Date
2022-11
MeSH
Coloring Agents ; Endometrial Neoplasms* / pathology ; Endometrial Neoplasms* / surgery ; Female ; Humans ; Indocyanine Green ; Lymph Node Excision / methods ; Lymph Nodes / pathology ; Neoplasm Staging ; Prospective Studies ; Quality of Life ; Republic of Korea ; Sentinel Lymph Node Biopsy / methods ; Sentinel Lymph Node* / pathology ; Sentinel Lymph Node* / surgery ; Single-Blind Method
Keywords
Endometrial Cancer ; Indocyanine Green ; Lymphadenectomy ; Prognosis ; Sentinel Lymph Node
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.

Trial registration: ClinicalTrials.gov Identifier (NCT number): NCT04845828.
Files in This Item:
T202300204.pdf Download
DOI
10.3802/jgo.2022.33.e73
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
Yonsei Authors
Kim, Sang Wun(김상운) ORCID logo https://orcid.org/0000-0002-8342-8701
Park, Eunhyang(박은향) ORCID logo https://orcid.org/0000-0003-2658-5054
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/192949
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