Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis

NCT03724903 | Completed

• 1 other identifier: Ductal-2018-Jun-14
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

A single-arm, proof-of-concept trial has shown the safety and efficacy of ductal lavage as a treatment for idiopathic granulomatous mastitis patients (Manuscript accepted in Journal of Surgical Research 2018). In this multicenter, randomized, open-labeled, non-inferior trial, the investigators are going to enroll eligible granulomatous mastitis patients and randomized them into ductal lavage versus. corticosteroids therapy group. The primary endpoint of this study is the complete clinical response rate at 1 year after the enrollment. The aim of this study is to provide evidence for the management of idiopathic granulomatous mastitis patients .

Conditions

Granulomatous Mastitis

Outcome Measures

Primary Outcomes (1)

• Complete Clinical Response(cCR)

  The proportion of patients that achieve M-score \<=1 at 1 year after the treatment.

  1 year since randomization

Secondary Outcomes (5)

• Time to cCR

  1 year since randomization

• Treatment failure (TF) rate

  1 year since randomization

• Relapse rate

  1 year since randomization

• Adverse events

  1 year since randomization

• Protocol compliance rate

  1 year since randomization

Study Arms (2)

Ductal lavage

EXPERIMENTAL

Ductal lavage and breast massage for two weeks.

Procedure: Ductal lavage

Corticosteroids therapy

ACTIVE COMPARATOR

Oral corticosteroids therapy for 6 months.

Drug: Corticosteroid therapy

Interventions

Ductal lavage PROCEDURE

The patients received ductal lavage and breast massage every other day for two weeks. We used lidocaine (1%) for local anesthesia around the nipple. We used a lacrimal probe to identify 4-5 openings in the lactiferous ducts on the nipple and inserted the infusion cannula (21-23G). A total of 25ml of irrigation solution (5 ml of 2% lidocaine, 40 mg of triamcinolone acetonide, 20 ml of 0.9% saline and 1.0 g of ceftriaxone) was pumped into the ducts over 20-25 minutes. The patient returned to the clinic the next day for breast massage, and the cycle was repeated for two weeks.

Ductal lavage

Corticosteroid therapy DRUG

Methylprednisolone(Common brand names: Medrol) or prednisone 20-40mg, qd for two weeks, then temper the dose gradually, and then 20mg qd for maintenance (The total duration of the treatment is 6 months).

Corticosteroids therapy

Eligibility Criteria

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

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 month after the cessation of lactation.
• Clinical and pathological diagnosis of idiopathic granulomatous mastitis.
• Never receive surgical treatments, or corticosteroids therapy after the cessation of lactation. Core needle biopsy is allowed.
• Good health, judged by clinicians, to receive ductal lavage.
• M score \>=2

You may not qualify if:

• Grade III inverted nipple(Plastic. Reconstruction. Surgery. 104: 389, 1999.)
• Lactational mastitis patients.
• Bilateral IGM patients.
• Clinically diagnosis of periductal mastitis.
• Pathological diagnosis of breast carcinoma.
• Pregnant women.
• Evidences suggest possible diagnosis of SLE(systemic lupus erythematosus), rheumatic disorders or other systematic auto-immune diseases.
• Evidences suggest possible diagnosis of tuberculosis.
• Evidences suggest possible diagnosis of fungus infection of the breast
• History of breast trauma.
• History of taking oral corticosteroids or anti-tuberculosis treatment.
• Imaging examinations indicates foreign objects retained in the breast
• Presence of sepsis or severe inflammation caused by IGM, for which surgery is likely required.
• 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

Study Sites (2)

Jiangmen Maternal and Child Health Care Population ＆ Family Planning Service Center

Jiangmen, Guangdong, 510000, China

Location

Lian Jiang People'S Hospital

Lianjiang, Guangdong, 524400, China

Location

Related Publications (3)

• Hu T, Li S, Huang H, Huang H, Tan L, Chen Y, Deng H, Wu J, Zhu L, Zhang J, Su F, Chen K. Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol. BMJ Open. 2020 Oct 10;10(10):e036643. doi: 10.1136/bmjopen-2019-036643.

  PMID: 33039992 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 BACKGROUND

• Chen X, Huang H, Huang H, Yong J, Zhu L, Chen Q, Tan L, Zeng Y, Yang Y, Zhao J, Rao N, Ding L, Wu W, Li Y, Gui X, Ye L, Xu Y, Jiang Y, Su L, Xiao Q, Cai X, Hu T, Tan C, Liu Q, Liu S, Zhao J, Wang Y, Yu F, Zhang J, Li S, Chen K. Ductal lavage followed by observation versus oral corticosteroids in idiopathic granulomatous mastitis: A randomized trial. Nat Commun. 2024 Oct 23;15(1):9144. doi: 10.1038/s41467-024-53143-2.

  PMID: 39443446 DERIVED

MeSH Terms

Conditions

Granulomatous Mastitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Erwei Song, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: October 30, 2018
• Study Start: April 1, 2019
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: October 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)