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 IceSense3TM 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.