Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis (MSTIGM)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Granulomatous Mastitis

Treatments: Drug: Hydrocortisone Butyrate; Procedure: extended excision

Study type: Interventional

Funder types: Other

Identifiers

NCT02959580

PUMCH-breast-mastitis

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic Granulomatous Mastitis

Exclusion criteria

• Breast Carcinoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

medical

Experimental group

Description:

Hydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment.

Treatment:

Drug: Hydrocortisone Butyrate

surgical

Active Comparator group

Description:

lesion extended excision

Treatment:

Procedure: extended excision