Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis

• Status: Recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: Female

Summary

A single-arm, proof-of-concept trial has shown the safety and efficacy of ductal lavage as a treatment for idiopathic granulomatous mastitis patients (Manuscript accepted in Journal of Surgical Research 2018). In this multicenter, randomized, open-labeled, non-inferior trial, the investigators are going to enroll eligible granulomatous mastitis patients and randomized them into ductal lavage versus. corticosteroids therapy group. The primary endpoint of this study is the complete clinical response rate at 1 year after the enrollment. The aim of this study is to provide evidence for the management of idiopathic granulomatous mastitis patients .

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Criteria

Inclusion Criteria:

• Female, age between 18 and 65 years old.

• Inform consent signed.

• Clinical diagnosis of non-lactating mastitis, defined as mastitis occurred more than 1 month after the cessation of lactation.

• Clinical and pathological diagnosis of idiopathic granulomatous mastitis.

• Never receive surgical treatments, or corticosteroids therapy after the cessation of lactation. Core needle biopsy is allowed.

• Good health, judged by clinicians, to receive ductal lavage.

• M score >=2

Exclusion Criteria:

• Grade III inverted nipple(Plastic. Reconstruction. Surgery. 104: 389, 1999.)

• Lactational mastitis patients.

• Bilateral IGM patients.

• Clinically diagnosis of periductal mastitis.

• Pathological diagnosis of breast carcinoma.

• Pregnant women.

• Evidences suggest possible diagnosis of SLE(systemic lupus erythematosus), rheumatic disorders or other systematic auto-immune diseases.

• Evidences suggest possible diagnosis of tuberculosis.

• Evidences suggest possible diagnosis of fungus infection of the breast

• History of breast trauma.

• History of taking oral corticosteroids or anti-tuberculosis treatment.

• Imaging examinations indicates foreign objects retained in the breast

• Patients with inappropriate coagulation function, cardiac function, pulmonary function, liver and renal function, that clinicians judges as not suitable to participate in this study.