Ductal Lavage in Non-lactating Female Women With Mastitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-06-05

Brief Summary

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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.

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Detailed Description

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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

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Mastitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ductal lavage group

The patients will receive ductal lavage therapy every other day for two weeks, and will be followed up for one year.

Ductal lavage therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No