Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis

Granulomatous Mastitis Clinical Trial

Official title: Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis: a Multicenter, Randomized, Open-labelled, Non-inferior Trial.

Status Completed

Clinical Trial 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 .

Clinical Trial Description

Non-lactational mastitis (NLM) consists of a broad spectrum of inflammatory breast diseases. Among them, periductal mastitis and idiopathic granulomatous mastitis(IGM) are the most commonly encountered in clinical practice. IGM can be diagnosed when all possible causes of granulomatous diseases (known mycobacterial or fungal infection, Wegener granulomatosis, sarcoidosis, etc.) are excluded. There is no consensus on the standard treatment of IGM patients. Surgery, oral corticosteroids, topical steroids, immunosuppressive therapy, and observation alone were all proposed as the treatment for IGM patients. However, all of the evidences are derived from retrospective studies. In a previous study, the investigators conducted a single-arm, proof-of-concept trial that showed the safety and efficacy of ductal lavage as a treatment for IGM patients. Ductal lavage is possible to spare the patients from corticosteroids therapy and or surgery. To further address this issue, the investigators are going to conduct this multicenter, randomized, open-labeled, non-inferior trial, to compare the efficacy and safety of ductal lavage and corticosteroids therapy. The aim of this study is to provide evidence for the management of IGM patients. ;

Related Conditions & MeSH terms

• Granulomatous Mastitis
• Mastitis

• NCT number: NCT03724903
• Study type: Interventional
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Completion date: April 21, 2023