Ductal Lavage in Non-lactating Female Women With Mastitis
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
Imethibitishwa Mwisho: | 07/31/2019 |
Iliyowasilishwa Kwanza: | 05/23/2016 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 06/04/2016 |
Iliyotumwa Kwanza: | 06/08/2016 |
Sasisho la Mwisho Liliwasilishwa: | 08/20/2019 |
Sasisho la Mwisho Lilichapishwa: | 08/21/2019 |
Tarehe halisi ya kuanza kwa masomo: | 07/31/2016 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 06/30/2018 |
Tarehe ya Kukamilisha Utafiti: | 06/04/2019 |
Hali au ugonjwa
Uingiliaji / matibabu
Procedure: Ductal lavage group
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
Ductal lavage group The patients will receive ductal lavage therapy every other day for two weeks, and will be followed up for one year. | Procedure: Ductal lavage group 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. |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
Jinsia Inastahiki Kujifunza | Female |
Njia ya sampuli | Non-Probability Sample |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | 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. |
Matokeo
Hatua za Matokeo ya Msingi
1. Time to complete response [Time from the initial treatment to first assessment of complete response, reported between day of first treatment and 1 year thereafter.]
Hatua za Matokeo ya Sekondari
1. 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.]
2. 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.]
3. 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.]
4. 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.]