Clinical Trial: Ductal Lavage in Non-lactating Female Women With Mastitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 Summary:

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
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Current Primary Outcome: 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. ]

Original Primary Outcome: 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. ]

Current Secondary Outcome:

• 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.
• Disease progression rate [ Time Frame: Evaluations were performed every week for the 1st month, and every other month thereafter until disease progression, reported between the day of first treatment and 1 year thereafter. ]
  The proportion of patients with diseases progression . Definition of disease progression is reaching one of the followings: 1) Significantly progression of the disease that require further medical treatment, such as oral cortisone, excisional drainage, or surgical incision. 2) The size of the target mass (Largest dimension) increased >20%, compared with that of the baseline.
• 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.

Original Secondary Outcome:

• Complete response rate [ Time Frame: Evaluations were performed every week for the 1st month, and every 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.
• Disease progression rate [ Time Frame: Evaluations were performed every week for the 1st month, and every month thereafter until disease progression, reported between the day of first treatment and 1 year thereafter. ]
  The proportion of patients with diseases progression within the first 2 weeks of treatment. Definition of disease progression is progression of the disease that require further medical treatment, such as oral intake of medications, systematic use of antibiotics, fine needle aspiration, or surgical incision.
• Relapse incidence after complete response [ Time Frame: Evaluations were performed every week for the 1st month, and every 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.
• Time to relapse after complete response [ Time Frame: Time from the initial treatment to first relapse after complete response, reported between the day of complete response and 1 year after the initial treatment. ]
  The length of time from the date of complete response to the date of relapse

Dates:
Date Received: May 24, 2016
Date Started: August 2016
Date Completion:
Last Updated: August 18, 2016
Last Verified: August 2016