Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis (MSTIGM)
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|ClinicalTrials.gov Identifier: NCT02959580|
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Granulomatous Mastitis||Drug: Hydrocortisone Butyrate Procedure: extended excision||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 2020|
Hydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment.
Drug: Hydrocortisone Butyrate
Active Comparator: surgical
lesion extended excision
Procedure: extended excision
Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).
- clinical response rate [ Time Frame: six months ]The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.
- granulomatous mastitis recurrence [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959580
|Contact: Yanna Zhang, M.D.||firstname.lastname@example.org|
|Department of Breast Surgery,Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Qiang Sun, Master 86-010-69158720 email@example.com|
|Contact: Yanna Zhang, Doctor 86-010-69158703 firstname.lastname@example.org|
|Principal Investigator: Qiang Sun, Master|
|Principal Investigator:||Qiang Sun, master||Peking Union Medical College Hospital|