Ductal Lavage in Non-lactating Female Women With Mastitis: A Single Arm, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time to complete response
研究概览
简要总结
RATIONALE and PURPOSE: For non-lactational mastitis patients pathologically diagnosis of idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), the investigators hypothesized that ductal lavage is able to relieve the symptoms and achieve complete response, with shorter recovery time than oral intake of antibiotics or corticosteroids treatments. This single arm, observational, case series, pilot study is going to evaluate the effectiveness of ductal lavage in patients with non-lactational IGM or PD.
详细描述
Inflammatory non-lactating breasts diseases encompasses a large spectrum of diseases ranging from infective diseases to autoimmune diseases, which cause considerable morbidity and difficulty in diagnosis. In daily practices, exclusion of possible diagnosis of breast carcinoma is the most important step. Aetiological factors for non-lactational mastitis include bacterial infection, tuberculosis, auto-immune disorders, etc. Treatments for these patients including antibiotics, anti-tuberculosis therapy, and corticosteroids treatments. Many of these patients were pathologically diagnosed as periductal mastitis (PD) or idiopathic granulomatous mastitis (IGM). The current treatment for PD or IGM include corticosteroids treatments, antibiotics and surgical treatments. Based on literature review, the complete response (CR) rate of corticosteroids and surgical treatment ranged between 63-87% and 89-100%, respectively. Time to CR ranged between 2-8 month for corticosteroid treatment.
Pathological findings of patients of IGM or PD revealed infiltrating inflammatory cells and neutrophilic microabscesses around the lobular units and partial ductal obstruction, we hypothesized that ductal lavage therapy will be able to relieve the symptom by dilating the lactiferous duct followed by irrigation solution flushing, with shorter recovery time and satisfactory CR rate. In our institution(Sun Yat-sen Memorial Hospital,Guangzhou, Guangdong, P.R.China), it is our routine practice to perform ductal lavage therapy to patients with non-lactating breasts diseases, especially for patients with IGM or PD, before we start corticosteroid or antibiotics treatments. For patients with evidence of bacterial infection, antibiotics was added into the irrigation solution. In our experience, many patients had short recovery time and low relapse rate, sparing the use of corticosteroid or antibiotics treatments. However, there is no concrete data to quantify the efficacy of ductal lavage therapy for IGM or PD patients. This observational study aims to prospectively enroll eligible patients and investigate the efficacy of ducal lavage therapy in IGM or PD patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 year after the cessation of lactation.
- •Never receive any treatments after the cessation of lactation.
- •Good health, judged by clinicians, to receive ductal lavage.
- •Pathologically diagnosed as idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD).
排除标准
- •Pathological diagnosis of breast carcinoma.
- •Pregnant women.
- •Evidences suggest possible diagnosis of systemic lupus erythematosus(SLE), rheumatic disorders or other systematic auto-immune diseases.
- •Evidences suggest possible diagnosis of tuberculosis.
- •Imaging examinations indicates foreign objects retained in the breast
- •Evidences suggest possible diagnosis of fungus infection of 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.
结局指标
主要结局
Time to complete response
时间窗: Time from the initial treatment to first assessment of complete response, reported between day of first treatment and 1 year thereafter.
The length of time from the date of initial treatment to the date of complete response. Complete response (CR) was defined as reaching all of the followings: 1) visual analogue score \<=1; 2) Disappearance of all local symptoms, such as redness, pain, swollen, etc. 3) Disappearance of fistula, if any; 4) The patient can return to normal life without any medical assistant.5) Disappearance of palpable or ultrasound detectable mass were defined as physical-CR and imaging-CR, respectively.
次要结局
- Progression incidence after partial response(Evaluations were performed every week for the 1st month, and every other month thereafter until disease progression, reported between the day of partial response and 1 year after the initial treatment.)
- Complete response rate(Evaluations were performed every week for the 1st month, and every other month thereafter until complete response, reported between the day of first treatment and 1 year thereafter.)
- Partial response rate(Evaluations were performed every week for the 1st month, and every other month thereafter until partial response, reported between the day of first treatment and 1 year thereafter.)
- Relapse incidence after complete response(Evaluations were performed every week for the 1st month, and every other month thereafter until relapse, reported between the day of complete response and 1 year after the initial treatment.)
研究者
Shunrong Li
Dr.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University