Objective: The SENTIREC-endo study aims to investigate risks and benefits of a national protocolled adoption of sentinel lymph node (SLN) mapping in women with early-stage low-grade endometrial cancer (EC) with low- (LR) and intermediate-risk (IR) of lymph node metastases. Methods: We performed a national multicenter prospective study of SLN-mapping in women with LR and IR EC from March 2017–February 2022. Postoperative complications were classified according to Clavien-Dindo. Lymphedema was assessed as a change score and as incidence of swelling and heaviness evaluated by validated patient-reported outcome measures at baseline and three months postoperatively. Results: 627 women were included in the analyses; 458 with LR- and 169 with IR EC. The SLN detection rate was 94.3% (591/627). The overall incidence of lymph node metastases was 9.3% (58/627); 4.4% (20/458) in the LR- and 22.5% (38/169) in the IR group. Ultrastaging identified 62% (36/58) of metastases. The incidence of postoperative complications was 8% (50/627) but only 0.3% (2/627) experienced an intraoperative complication associated with the SLN procedure. The lymphedema change score was below the threshold for clinical importance 4.5/100 CI: (2.9–6.0), and the incidence of swelling and heaviness was low; 5.2% and 5.8%, respectively. Conclusion: SLN mapping in women with LR and IR EC carries a very low risk of early lymphedema and peri- and postoperative complications. The national change in clinical practice contributed to a more correct treatment allocation for both risk groups and thus supports further international implementation of the SLN technique in early stage, low grade EC.
|Status||Udgivet - apr. 2023|
Bibliografisk noteFunding Information:
Rigshospitalet, Herlev Hospital, and Aarhus University Hospital made institutional payments of local running costs of ultrastaging. The project was further funded by Odense University Hospitals Free Research Foundation, Odense University Hospitals Front Line Research Foundation, Arhus University, and the Vissing Fond. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of data; preparation; review, or approval of the manuscript.