Ductal Lavage in Non-lactating Female Women With Mastitis
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|ClinicalTrials.gov Identifier: NCT02794688|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment|
|Mastitis||Procedure: Ductal lavage therapy|
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.
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||Ductal Lavage in Non-lactating Female Women With Mastitis: A Single Arm, Observational Study|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||June 5, 2019|
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 therapy
- Time to complete response [ Time Frame: Time from the initial treatment to first assessment of complete response, reported between day of first treatment and 1 year thereafter. ]The length of time from the date of initial treatment to the date of complete response. Complete response (CR) was defined as reaching all of the followings: 1) visual analogue score <=1; 2) Disappearance of all local symptoms, such as redness, pain, swollen, etc. 3) Disappearance of fistula, if any; 4) The patient can return to normal life without any medical assistant.5) Disappearance of palpable or ultrasound detectable mass were defined as physical-CR and imaging-CR, respectively.
- Complete response rate [ Time Frame: 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. ]The proportion of patients with complete response within 1 year after the initial treatment.
- Partial response rate [ Time Frame: 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. ]The proportion of patients with partial response within 1 year after the initial treatment. Partial response was defined as reaching all of the followings: 1) decreased visual analogue score>=2; 2) Significantly relieved of all local symptoms, such as redness, pain, swollen, etc. 3) Disappearance of spontaneous discharge through fistula, if any; 4) The patient stated that the symptom is relieved significantly.5) Size of the target mass (Largest dimension) is reduced >30%, compared with that of the baseline. Partial response assessed by physical and ultrasound were defined as physical-partial-response and imaging-partial-response, respectively.
- Relapse incidence after complete response [ Time Frame: 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. ]The incidence of relapse after complete response, within 1 year after the initial treatment. Definition of relapse including any of the followings: 1) Notice of new palpable mass; 2) Notice of new fistula; 3) Notice of new local symptoms, such as pain, redness, swollen and heated skin. Only patients with complete response during the study follow-up will be assessed for this outcome.
- Progression incidence after partial response [ Time Frame: 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. ]The incidence of progression after partial response, within 1 year after the initial treatment. Definition of progression including any of the followings: 1) Progression of local symptoms (redness, swelling, tenderness, pain, fever) significantly. ; 2) Notice of new fistula; 3) The size of the target mass (Largest dimension) increased >20%, compared with that of the day of partial response. Only patients with partial response during the study follow-up will be assessed for this outcome.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794688
|Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University|
|Guangzhou, Guangdong, China, 510120|
|Principal Investigator:||Shunrong Li, M.D.||Sun Yat-sen Memorial Hospital,Sun Yat-sen University|
|Study Director:||Erwei Song, M.D.||Sun Yat-sen Memorial Hospital,Sun Yat-sen University|