Ductal Lavage in Non-lactating Female Women With Mastitis
Condition: Mastitis
MeSH terms: Mastitis
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ductal lavage therapy
Intervention type(s): Procedure
Intervention description(s): Patient lies in supine position, with routine sterilizing and draping procedure.
Local anesthesia with 2ml lidocaine (1%) around the nipple.
Identification of 4-5 openings of the lactiferous ducts from the nipple.
Insertion of all infusion cannula (21-23G ) into the identified openings of the lactiferous ducts.
Start the infusion pump with 15ml irrigation solution (2% Lidocaine 5ml, Triamcinolone acetonide 40mg，0.9% saline 10ml and ceftriaxone 1.0g). If the patients had elevated white blood cell count and fever (>38 celsius degree), oral intake or infusion of antibiotics were allowed, when necessary.
The patient returns to the clinic the next day, with the irrigation solution staying in the lactiferous ducts overnight, and receives breast massage.
Repeat step 1-6 every other day for 2 weeks.
Fine needle aspiration is allowed. Oral intake of corticosteroids, excisional drainage or surgery are not allowed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with non-lactating mastitis, pathologically diagnosed as idiopathic granulomatous
        mastitis (IGM) or periductal mastitis (PD), were included in this study.
      
Biospecimen description: 
      All patients are required to have biopsy to exclude breast carcinoma. The storage of the
      biospecimen will follow the standard of practices of Sun Yat-sen Memorial Hospital.
    
Keywords: Non-lactating; idiopathic granulomatous mastitis; periductal mastitis; ductal lavage