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Assessment of sentinel Lymph node mapping with different volumes of Indocyanine green in early-stage ENdometrial cancer: the ALIEN study
  1. Jessica Mauro1,
  2. Diego Raimondo2,
  3. Giampaolo Di Martino3,
  4. Maria Luisa Gasparri4,
  5. Stefano Restaino5,
  6. Daniele Neola2,
  7. Luca Clivio6,
  8. Carmelo Calidona7,
  9. Robert Fruscio3,
  10. Giuseppe Vizzielli5,
  11. Stefano Uccella7,
  12. Andrea Papadia4,
  13. Renato Seracchioli2,8 and
  14. Alessandro Buda1
    1. 1 Gynecologic Oncology, Ospedale Michele e Pietro Ferrero, Verduno, Italy
    2. 2 Division of Gynaecology and Human Reproduction Physiopathology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
    3. 3 Clinic of Obstetrics and Gynecology, IRCCS San Gerardo, University of Milano-Bicocca, Monza, Italy
    4. 4 Department of Gynecology and Obstetrics, Faculty of Biomedical Science Università della Svizzera Italiana, Ente Ospedaliero Cantonale, Lugano, Switzerland
    5. 5 Clinic of Obstetrics and Gynecology, University of Udine, Ospedale Santa Maria della Misericordia, Udine, Italy
    6. 6 Unit of Analytics, Research & Communication - Area ICT, Ente Ospedaliero Cantonale, Lugano, Switzerland
    7. 7 Department of Obstetrics and Gynecology, University of Verona, Verona, Italy
    8. 8 Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy
    1. Correspondence to Dr Alessandro Buda, Gynecologic Oncology, Ospedale Michele e Pietro Ferrero, Verduno, Italy; alebuda1972{at}gmail.com

    Abstract

    Objective To evaluate the impact of different volumes of indocyanine green (ICG) on the detection rate and bilateral mapping of sentinel lymph nodes in patients with apparent uterine-confined endometrial cancer.

    Methods All patients who underwent surgical staging with sentinel node mapping in six reference centers were included. Two different protocols of ICG intracervical injection were used: (1) 2 mL group: total volume of 2 mL injected superficially; (2) 4 mL group: total volume of 4 mL, 2 mL deeply and 2 mL superficially. Logistic regression was used to analyze factors that could influence dye migration and detection rates. A sensitivity analysis was carried out to determine how independent variables could affect the sentinel node detection rate.

    Results Of 442 eligible patients, 352 were analyzed (172 in the 2 mL group and 180 in the 4 mL group). The bilateral detection rates of the 2 mL and 4 mL groups were 84.9% and 86.1%, respectively (p=0.76). The overall detection rate was higher with a volume of 4 mL than with 2 mL (97.8% vs 92.4%, respectively; p=0.024). In the univariate analysis the rate of bilateral mapping fell from 87.5% to 73.5% when the International Federation of Gynecology and Obstetrics (FIGO) 2009 tumor stage was >IB (p=0.018). In the multivariate analysis, for both overall and bilateral detection rates a statistically significant difference emerged for the volume of ICG injected and FIGO 2009 stage >IB. Increasing body mass index was associated with worse overall detection rates on univariate analysis (p=0.0006), and significantly decreased from 97% to 91% when the body mass index exceeded 30 kg/m2 (p=0.05).

    Conclusions In patients with early-stage endometrial cancer, a volume of 2 mL ICG does not seem to compromise the bilateral detection of sentinel lymph nodes. In women with obesity and FIGO 2009 stage >IB, a 4 mL injection should be preferred.

    • Endometrial Neoplasms
    • Sentinel Lymph Node
    • Surgical Procedures, Operative

    Data availability statement

    In accordance with the journal’s guidelines, we will provide our data for independent analysis by a selected team by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested. Data are available upon reasonable request as journal guidelines states.

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    Data availability statement

    In accordance with the journal’s guidelines, we will provide our data for independent analysis by a selected team by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested. Data are available upon reasonable request as journal guidelines states.

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    Footnotes

    • X @jess393, @giusvizzielli

    • Correction notice This article has been corrected since it was first published. Author affiliations 2 and 8 have been updated, and minor typographical errors have been corrected in the main text.

    • Contributors Conceptualization: JM, AB. Data curation: all authors. Formal analysis: LC, JM, AB. Investigation: all authors. Methodology: JM, LC, AB. Supervision: AB, DR, GV. Writing - original draft: JM, AB. Writing - review and editing: JM, AB, DR, RS, RF, GDM, AP, SU, SR, GV. AB was responsible for the overall content as guarantor.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.