Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis: a Multicenter, Randomized, Open-labelled, Non-inferior Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Complete Clinical Response(cCR)
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Presence of sepsis or severe inflammation caused by IGM, for which surgery is likely required.
- •Patients with inappropriate coagulation function, cardiac function, pulmonary function, liver and renal function, that clinicians judges as not suitable to participate in this study.
研究组 & 干预措施
Corticosteroids therapy
Oral corticosteroids therapy for 6 months.
干预措施: Corticosteroid therapy (Drug)
Ductal lavage
Ductal lavage and breast massage for two weeks.
干预措施: Ductal lavage (Procedure)
结局指标
主要结局
Complete Clinical Response(cCR)
时间窗: 1 year since randomization
The proportion of patients that achieve M-score \<=1 at 1 year after the treatment.
次要结局
- Treatment failure (TF) rate(1 year since randomization)
- Time to cCR(1 year since randomization)
- Relapse rate(1 year since randomization)
- Adverse events(1 year since randomization)
- Protocol compliance rate(1 year since randomization)
研究者
Chen Kai
Dr.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University