Mastitis Clinical Trial
Official title:
Ductal Lavage in Non-lactating Female Women With Mastitis: A Single Arm, Observational Study
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.
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.
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