Clinical trial NCT02794688: Ductal Lavage in Non-lactating Female Women With Mastitis
Official title: Ductal Lavage in Non-lactating Female Women With Mastitis: A Single Arm, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mastitis
Keywords: Non-lactating
idiopathic granulomatous mastitis
periductal mastitis
ductal lavage
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou Jie Jian Instrument Co,Ltd
name: China Anti-aging Promoting Association
First posted: 2016-06-09
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with non-lactating mastitis, pathologically diagnosed as idiopathic granulomatous mastitis (IGM) or periductal mastitis (PD), were included in this 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to complete response
timeFrame: Time from the initial treatment to first assessment of complete response, reported between day of first treatment and 1 year thereafter.
Secondary outcomes:
measure: Complete response rate
timeFrame: 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.
measure: Partial response rate
timeFrame: 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.
measure: Relapse incidence after complete response
timeFrame: 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.
measure: Progression incidence after partial response
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Shunrong Li, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Erwei Song, M.D.
role: STUDY_DIRECTOR
References:
citation: Bouton ME, Jayaram L, O'Neill PJ, Hsu CH, Komenaka IK. Management of idiopathic granulomatous mastitis with observation. Am J Surg. 2015 Aug;210(2):258-62. doi: 10.1016/j.amjsurg.2014.08.044. Epub 2015 Feb 7.
citation: Gautier N, Lalonde L, Tran-Thanh D, El Khoury M, David J, Labelle M, Patocskai E, Trop I. Chronic granulomatous mastitis: Imaging, pathology and management. Eur J Radiol. 2013 Apr;82(4):e165-75. doi: 10.1016/j.ejrad.2012.11.010. Epub 2012 Nov 29.
citation: Gopalakrishnan Nair C, Hiran, Jacob P, Menon RR, Misha. Inflammatory diseases of the non-lactating female breasts. Int J Surg. 2015 Jan;13:8-11. doi: 10.1016/j.ijsu.2014.11.022. Epub 2014 Nov 22.
citation: Lacambra M, Thai TA, Lam CC, Yu AM, Pham HT, Tran PV, Law BK, Van Nguyen T, Pham DX, Tse GM. Granulomatous mastitis: the histological differentials. J Clin Pathol. 2011 May;64(5):405-11. doi: 10.1136/jcp.2011.089565. Epub 2011 Mar 8.
citation: Chen K, Zhu L, Hu T, Tan C, Zhang J, Zeng M, Li S, Song E. Ductal Lavage for Patients With Nonlactational Mastitis: A Single-Arm, Proof-of-Concept Trial. J Surg Res. 2019 Mar;235:440-446. doi: 10.1016/j.jss.2018.10.023. Epub 2018 Nov 19.