Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis

NCT ID: NCT03724903

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-04-21

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 .

Detailed Description

Non-lactational mastitis (NLM) consists of a broad spectrum of inflammatory breast diseases. Among them, periductal mastitis and idiopathic granulomatous mastitis(IGM) are the most commonly encountered in clinical practice. IGM can be diagnosed when all possible causes of granulomatous diseases (known mycobacterial or fungal infection, Wegener granulomatosis, sarcoidosis, etc.) are excluded. There is no consensus on the standard treatment of IGM patients. Surgery, oral corticosteroids, topical steroids, immunosuppressive therapy, and observation alone were all proposed as the treatment for IGM patients. However, all of the evidences are derived from retrospective studies. In a previous study, the investigators conducted a single-arm, proof-of-concept trial that showed the safety and efficacy of ductal lavage as a treatment for IGM patients. Ductal lavage is possible to spare the patients from corticosteroids therapy and or surgery. To further address this issue, the investigators are going to conduct this multicenter, randomized, open-labeled, non-inferior trial, to compare the efficacy and safety of ductal lavage and corticosteroids therapy. The aim of this study is to provide evidence for the management of IGM patients.

Conditions

Granulomatous Mastitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ductal lavage

Ductal lavage and breast massage for two weeks.

Group Type: EXPERIMENTAL

Ductal lavage

Intervention Type: 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.

Corticosteroids therapy

Oral corticosteroids therapy for 6 months.

Group Type: ACTIVE_COMPARATOR

Corticosteroid therapy

Intervention Type: 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).

Interventions

Ductal lavage

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.

Intervention Type: PROCEDURE

Corticosteroid therapy

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).

Intervention Type: DRUG

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 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Chen Kai

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erwei Song, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Jiangmen, Guangdong, China

Lian Jiang People'S Hospital

Lianjiang, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 33039992 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30691827 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39443446 (View on PubMed)

Other Identifiers

Ductal-2018-Jun-14

Identifier Type: -

Identifier Source: org_study_id