NCT02794688

Ductal Lavage in Non-lactating Female Women With Mastitis

Ductal Lavage in Non-lactating Female Women With Mastitis: A Single Arm, Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mastitis

Interventions

Type	Name	Description
PROCEDURE	Ductal lavage therapy	1. Patient lies in supine position, with routine sterilizing and draping procedure. 2. Local anesthesia with 2ml lidocaine (1%) around the nipple. 3. Identification of 4-5 openings of the lactiferous ducts from the nipple. 4. Insertion of all infusion cannula (21-23G ) into the identified openings of the lactiferous ducts. 5. 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. 6. The patient returns to the clinic the next day, with the irrigation solution staying in the lactiferous ducts overnight, and receives breast massage. 7. Repeat step 1-6 every other day for 2 weeks. 8. Fine needle aspiration is allowed. Oral intake of corticosteroids, excisional drainage or surgery are not allowed.

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-07-01
• Completion: 2019-06-05
• First posted: 2016-06-09
• Last updated: 2019-08-22

Locations

1 site across 1 country: China