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Ultrasound examination, MRI, or ROMA for discriminating between inconclusive adnexal masses as determined by IOTA Simple Rules: a prospective study
  1. Enrique Chacon1,
  2. Maria Arraiza2,
  3. Nabil Manzour1,
  4. Alberto Benito2,
  5. José Ángel Mínguez1,
  6. Daniel Vázquez-Vicente3,
  7. Teresa Castellanos3,
  8. Luis Chiva3 and
  9. Juan Luis Alcazar1
  1. 1 Department of Obstetrics and Gynecology, Universidad de Navarra, Pamplona, Navarra, Spain
  2. 2 Department of Radiology, Clínica Universidad de Navarra, Pamplona, Spain
  3. 3 Department of Gynecology, Clinica Universitaria de Navarra, Madrid, Spain
  1. Correspondence to Dr Juan Luis Alcazar, Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Pamplona 31008, Spain; jlalcazar{at}unav.es

Abstract

Objective To determine the best second-step approach for discriminating benign from malignant adnexal masses classified as inconclusive by International Ovarian Tumour Analysis Simple Rules (IOTA-SR).

Methods Single-center prospective study comprising a consecutive series of patients diagnosed as having an adnexal mass classified as inconclusive according to IOTA-SR. All women underwent Risk of Ovarian Malignancy Algorithm (ROMA) analysis, MRI interpreted by a radiologist, and ultrasound examination by a gynecological sonologist. Cases were clinically managed according to the result of the ultrasound expert examination by either serial follow-up for at least 1 year or surgery. Reference standard was histology (patient was submitted to surgery if any of the tests was suspicious) or follow-up (masses with no signs of malignancy after 12 months were considered benign). Diagnostic performance of all three approaches was calculated and compared. Direct cost analysis of the test used was also performed.

Results Eighty-two adnexal masses in 80 women (median age 47.6 years, range 16 to 73 years) were included. Seventeen patients (17 masses) were managed expectantly (none had diagnosis of ovarian cancer after at least 12 months of follow-up) and 63 patients (65 masses) underwent surgery and tumor removal (40 benign and 25 malignant tumors). Sensitivity and specificity for ultrasound, MRI, and ROMA were 96% and 93%, 100% and 81%, and 24% and 93%, respectively. The specificity of ultrasound was better than that for MRI (p=0.021), and the sensitivity of ultrasound was better than that for ROMA (p<0.001), sensitivity was better for MRI than for ROMA (p<0.001) and the specificity of ROMA was better than that for MRI (p<0.001). Ultrasound evaluation was the most effective and least costly method as compared with MRI and ROMA.

Conclusion In this study, ultrasound examination was the best second-step approach in inconclusive adnexal masses as determined by IOTA-SR, but the findings require confirmation in multicenter prospective trials.

  • ovarian cancer
  • surgery
  • gynecology

Data availability statement

Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request.

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Footnotes

  • EC and MA are joint first authors.

  • Twitter @Quique_ChC, @Juan_L_Alcazar

  • EC and MA contributed equally.

  • Contributors Study conception and design: JLA; Patient recruitment: EC; Data acquisition: EC, MA, NM, TC, DV, MA; Data analysis: JLA, EC, MA; Data interpretation: all authors. Guarantor: JLA.

  • Funding This study was funded by Instituto de Salud Carlos III, Spain (grant number: PI17/01326).

  • 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.