Ultrasound-guided cryoablation of breast fibroadenoma: a pilot trial.

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.

• Authors: Michael Golatta, Aba Harcos, David Pavlista, Jan Danes, Rafi Klein, Paola Simovich, Ines Gruber, Markus Hahn
• Journal: Archives of gynecology and obstetrics (Arch Gynecol Obstet) Vol. 291 Issue 6 Pg. 1355-60 (Jun 2015) ISSN: 1432-0711 [Electronic] Germany
• PMID: 25408274 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Topics

• Adult
• Aged
• Breast Neoplasms (pathology, surgery)
• Cryosurgery (methods)
• Female
• Fibroadenoma (pathology, surgery)
• Follow-Up Studies
• Humans
• Middle Aged
• Pain (etiology)
• Pilot Projects
• Prospective Studies
• Treatment Outcome