Ductal Lavage in Non-lactating Female Women With Mastitis

NCT02794688 | Completed

• 1 other identifier: DLNLM-01
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastitis

Keywords

Non-lactating; idiopathic granulomatous mastitis; periductal mastitis; ductal lavage

Outcome Measures

Primary Outcomes (1)

• Time to complete response

  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.

  Time from the initial treatment to first assessment of complete response, reported between day of first treatment and 1 year thereafter.

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

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

Interventions

Ductal lavage therapy 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.

Ductal lavage group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Guangzhou Jie Jian Instrument Co,Ltd: collaborator
• China Anti-aging Promoting Association: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

Related Publications (5)

• 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.

  PMID: 25746911 BACKGROUND

• 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.

  PMID: 23200627 BACKGROUND

• 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.

  PMID: 25447605 BACKGROUND

• 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.

  PMID: 21385894 BACKGROUND

• 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.

  PMID: 30691827 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

All patients are required to have biopsy to exclude breast carcinoma. The storage of the biospecimen will follow the standard of practices of Sun Yat-sen Memorial Hospital.

MeSH Terms

Conditions

Mastitis

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shunrong Li, M.D.

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

  PRINCIPAL INVESTIGATOR

• Erwei Song, M.D.

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 9, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: June 5, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)