TY - JOUR
T1 - Hysteroscopic versus cervical injection for sentinel node detection in endometrial cancer
T2 - A multicenter prospective randomised controlled trial from the Multicenter Italian Trials in Ovarian cancer (MITO) study group
AU - Ditto, Antonino
AU - Casarin, Ivan
AU - Perrone, Anna M.
AU - Scollo, Paolo
AU - Martinelli, Fabio
AU - Bogani, Giorgio
AU - Maggiore, Umberto L.R.
AU - Signorelli, Mauro
AU - Chiappa, Valentina
AU - Giorda, Giorgio
AU - Scibilia, Giuseppe
AU - De Iaco, Pierandrea
AU - Evangelista, Mariateresa
AU - Ghezzi, Fabio
AU - Paolini, Biagio
AU - Lo Vullo, Salvatore
AU - Mariani, Luigi
AU - Montone, Rosanna
AU - Raspagliesi, Francesco
N1 - Funding Information:
The Fondazione IRCCS National Cancer Institute of Milan supported this investigation.The authors are very grateful to the Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) National Cancer Institute of Milan, Italy, for their support of this trial. The authors would like to acknowledge the contributions by all the surgeons involved in the trial across all sites, the research administrators and coordinators and the operating room personnel who assisted in the conduct of this study. The authors would like to thank Dr Giulia Dondi, Dr Ciro Pinelli and Dr Anna Del Fabro. The authors thank the members of the data safety monitoring committee for their critical supervision during the conduct of the trial. The authors also thank Dr Iolanda Pulice for administrative support and her colleagues who patiently cared for central randomisation over many years. The authors are grateful to the Fondazione IRCCS National Cancer Institute of Milan, Italy, the MITO study Group and their clinical, research and administrative members for their leadership and commitment to the trial.
Publisher Copyright:
© 2020 Elsevier Ltd
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/11
Y1 - 2020/11
N2 - Aim: During the last years, the role of sentinel lymph node mapping (SLNM) for endometrial cancer (EC) surgical treatment has increased in popularity. However, several controversies remain about different technical steps of SLNM. Thus, a randomised control trial was designed to compare cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The primary end-point of the study was to compare these two techniques in terms of para-aortic detection rate. Methods: Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study. This randomised trial distinguished patients in two study groups according to two different techniques of ICG SLNM: CI versus HI injection. Patients who met the inclusion criteria were randomly assigned to CI or HI injection in a 1:1 ratio. The central randomisation system allocated patient randomisation numbers sequentially in the order in which the patients were enrolled. This randomised trial was not blinded for either patients or the surgeons. Results: From March 2017 until April 2019, a total of 165 patients were randomised in this study: 85 (51.5%) in the CI group and 80 (48.5%) in the HI group. After randomisation, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group. Hysteroscopy injection shows an ability to detect Sentinel nodes (SNLs) in the para-aortic area of about 10% greater compared with CI injection, although this difference did not reach statistical significance. The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%). The CI injection was correlated with higher SLN detection rates at the pelvic level compared with HI injection. Pelvic and overall detection was higher in the CI group. Conclusions: The present study supports the adoption of CI instead of HI injection because the former allows better identification of sentinel nodes (especially in the pelvic area). Detection of SLN in the para-aortic area was slightly higher in patients receiving a HI injection, but the difference with the CI route was not statistically significant.
AB - Aim: During the last years, the role of sentinel lymph node mapping (SLNM) for endometrial cancer (EC) surgical treatment has increased in popularity. However, several controversies remain about different technical steps of SLNM. Thus, a randomised control trial was designed to compare cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The primary end-point of the study was to compare these two techniques in terms of para-aortic detection rate. Methods: Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study. This randomised trial distinguished patients in two study groups according to two different techniques of ICG SLNM: CI versus HI injection. Patients who met the inclusion criteria were randomly assigned to CI or HI injection in a 1:1 ratio. The central randomisation system allocated patient randomisation numbers sequentially in the order in which the patients were enrolled. This randomised trial was not blinded for either patients or the surgeons. Results: From March 2017 until April 2019, a total of 165 patients were randomised in this study: 85 (51.5%) in the CI group and 80 (48.5%) in the HI group. After randomisation, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group. Hysteroscopy injection shows an ability to detect Sentinel nodes (SNLs) in the para-aortic area of about 10% greater compared with CI injection, although this difference did not reach statistical significance. The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%). The CI injection was correlated with higher SLN detection rates at the pelvic level compared with HI injection. Pelvic and overall detection was higher in the CI group. Conclusions: The present study supports the adoption of CI instead of HI injection because the former allows better identification of sentinel nodes (especially in the pelvic area). Detection of SLN in the para-aortic area was slightly higher in patients receiving a HI injection, but the difference with the CI route was not statistically significant.
KW - Endometrial cancer
KW - Gynaecologic oncology
KW - Hysteroscopic injection of tracer
KW - Sentinel node mapping
KW - Surgery
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U2 - 10.1016/j.ejca.2020.08.030
DO - 10.1016/j.ejca.2020.08.030
M3 - Article
C2 - 33027722
AN - SCOPUS:85091964417
VL - 140
SP - 1
EP - 10
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
ER -