Clinical Trial: Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis
Brief Summary: This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.
Detailed Summary:
Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.It may present with many findings that clinically and radiologically mimic breast cancer.
Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference.
Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.
Sponsor: Peking Union Medical College Hospital
Current Primary Outcome: clinical response rate [ Time Frame: six months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: granulomatous mastitis recurrence [ Time Frame: two years ]
Original Secondary Outcome: Same as current
Information By: Peking Union Medical College Hospital
Dates:
Date Received: November 7, 2016
Date Started: January 1, 2017
Date Completion:
Last Updated: January 18, 2017
Last Verified: January 2017
