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Archives of Gynecology and Obstetrics

, Volume 291, Issue 6, pp 1355–1360 | Cite as

Ultrasound-guided cryoablation of breast fibroadenoma: a pilot trial

  • Michael Golatta
  • Aba Harcos
  • David Pavlista
  • Jan Danes
  • Rafi Klein
  • Paola Simovich
  • Ines Gruber
  • Markus Hahn
Gynecologic Oncology

Abstract

Purpose

The aim of the study was to evaluate cryoablation (CA) under ultrasound guidance in the office setting with liquid nitrogen system for patients with fibroadenoma (FA).

Methods

For this prospective multicenter trial, an office-based cryosurgical system was used to treat histological confirmed benign FA with a maximum dimension of 3 cm. Sixty CA procedures were performed under ultrasound guidance. A freeze–thaw–freeze treatment cycle was performed according to the size of the FA. During the CA procedure continuous ultrasound monitoring was performed, verifying engulfment of the FA. Patients attended four follow-up visits at 1 week, 3, 6 months and 1 year and underwent ultrasound, physical examination and photography.

Results

Data were collected and analyzed in 60 cases. 59 of 60 FA (98 %) were fully engulfed by the ice ball. No serious adverse events occurred related to the IceSense3™ system. At the 1-year follow-up, the FAs were gone in 93 % of the cases. Prior to CA procedure, 76 % of the FAs were palpable. Afterwards in some cases (22 %), a scar/cryo lesion was palpable. 28 % of the patients reported pain, described as mild or moderate, compared to 2 % after 1 year. Cosmetic results at 12 months follow-up were reported as good or excellent in 100 % by physician and in 97 % by patients.

Conclusions

The cryodestruction of the FA using liquid nitrogen system proved functional and safe, while showing meaningful reduction in volume, palpability, pain and cosmetic satisfying outcomes.

Keywords

Cryoablation Ultrasound Fibroadenoma Office-based procedure Cryotherapy Breast 

Notes

Acknowledgments

Financial activities related to the present article: Institutions received grant for research support and loan of prototype IceSense3™ for the research from IceCure Medical (formerly Arbel-Medical).

Conflict of interest

The authors declare that they have no conflict of interest.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Michael Golatta
    • 1
  • Aba Harcos
    • 1
  • David Pavlista
    • 2
  • Jan Danes
    • 3
  • Rafi Klein
    • 4
  • Paola Simovich
    • 4
  • Ines Gruber
    • 5
  • Markus Hahn
    • 5
  1. 1.Department of Obstetrics and GynecologyUniversity Hospital of Heidelberg, University Breast UnitHeidelbergGermany
  2. 2.Department of Obstetrics and Gynecology, First Faculty of Medicine, Oncogynecological CenterCharles University in Prague and General University Hospital in PraguePragueCzech Republic
  3. 3.Department of Radiology, First Faculty of MedicineCharles University in PraguePragueCzech Republic
  4. 4.Assuta Medical CentersHaifaIsrael
  5. 5.Department of Obstetrics and GynecologyUniversity Hospital of TuebingenTübingenGermany

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