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Let go of the myth: safety of indocyanine green for sentinel lymph node mapping in endometrial cancer
  1. Ilaria Capasso1,2,
  2. Giuseppe Cucinella3,
  3. Gerald Volcheck4,
  4. Michaela McGree5,
  5. Angela J Fought5,
  6. Olena Chuzhyk1,
  7. Luigi Antonio De Vitis6,
  8. Gabriella Schivardi6,
  9. Diletta Fumagalli7,
  10. Tommaso Occhiali8,
  11. Francesco Fanfani2,
  12. Vito Chiantera9,
  13. Giovanni Scambia2,
  14. Evelyn Reynolds1,
  15. Andrea Mariani1 and
  16. Gretchen Glaser1
  1. 1 Department of Gynecologic Oncology, Mayo Clinic, Rochester, Minnesota, USA
  2. 2 Department of Women, Children and Public Health Sciences, Gynecologic Oncology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Lazio, Italy
  3. 3 Department of Surgical, Oncological and Oral Sciences (Di.Chir.On.S.), University of Palermo, Palermo, Sicilia, Italy
  4. 4 Division of Allergic Diseases, Mayo Clinic, Rochester, Minnesota, USA
  5. 5 Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota, USA
  6. 6 Department of Gynecology, European Institute of Oncology, Milano, Italy
  7. 7 Department of Obstetrics and Gynecology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardia, Italy
  8. 8 Department of Obstetrics and Gynecology, Santa Maria della Misericordia University Hospital, Udine, Friuli-Venezia Giulia, Italy
  9. 9 Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, Palermo, Sicilia, Italy
  1. Correspondence to Dr Gretchen Glaser, Department of Gynecologic Oncology, Mayo Clinic, Rochester, Minnesota, USA; glaser.gretchen{at}mayo.edu

Abstract

Objective Sentinel lymph node mapping by intracervical indocyanine green injection is the preferred method for surgical staging in endometrial cancer. Adverse reactions to indocyanine green are extremely rare, and information about the safety of this tracer in patients with a history of other allergies, asthma, or comorbidities is limited. We aim to evaluate the rate of adverse reactions to indocyanine green injected during sentinel lymph node mapping in patients with endometrial cancer and review the etiology of such reactions.

Methods All patients with endometrial cancer undergoing sentinel lymph node mapping with indocyanine green cervical stroma injection at the Mayo Clinic in Rochester, Minnesota between June 2014 and December 2018 were retrospectively evaluated. Any adverse reaction occurring intra-operatively or within 7 days after surgery was identified. A thorough chart review was performed by an allergy specialist physician for any patient with an allergic-type reaction.

Results We included 923 patients of which 565 (61.2%) had a history of allergy to antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), other medications, and/or environmental exposures. Of 490 patients who had previously received contrast media, 25 (5.1%) had a history of an adverse reaction. No immediate anaphylaxis or other allergic reactions were observed after indocyanine green injection. 10 (1.1%) patients developed a transient skin reaction within 7 days after surgery. None of these patients had a history of contrast media reaction. Based on timing and clinical/peri-operative history of affected patients, it was determined that skin reactions were likely induced by other newly prescribed medications or contact sensitivity, not administration of indocyanine green.

Conclusion Indocyanine green injection for sentinel lymph node mapping in patients with endometrial cancer caused no immediate/delayed anaphylactic or other severe allergic reactions. This included patients with a history of other allergies, asthma, and comorbidities. The myth of iodine’s relationship to allergic reactions must be refuted to allow indocyanine green use in patients with a history of contrast media or shellfish allergy.

  • Endometrial Neoplasms
  • Sentinel Lymph Node

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.

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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.

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Footnotes

  • Twitter @Cucinella_G, @LuigiDEvitis

  • IC and GC contributed equally.

  • Contributors IC and GC contributed equally and are joint first authors. All listed authors have contributed to the manuscript preparation. Guarantor: GG and AM. Conceived and designed the study: IC, GC, GG, AM. Data collection, analysis, and interpretation: IC, GC, OC, MM, AF, AM, GG. Writing, review, and editing: all authors.

  • 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.