Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis

Harbin Medical University

Status: Enrolling

Conditions: Granulomatous Mastitis

Treatments: Drug: triple anti-tuberculosis drug; Procedure: Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06565845

2024182

Details and patient eligibility

About

Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.

Full description

In recent years, the incidence of this disease has been increasing annually. The incidence of GLM is region-specific, being higher in Mediterranean regions and Asian countries. The etiology is currently unclear, but many studies suggest that GLM is associated with autoimmune disorders, hormonal imbalances, and microbial infections . GLM has a long course, is difficult to treat, and prone to recurrence, causing significant trauma to the patient's breast appearance and overall well-being. Currently, the main treatment methods for GLM include surgical treatment, drug therapy, combined surgery with drug therapy, and close observation. Surgical treatment options mainly include abscess incision and drainage, segmental resection, subcutaneous mastectomy, mastectomy, and breast reconstruction. Although surgical treatment can rapidly improve the condition, the recurrence rate reported in the literature ranges from 5% to 50% . Although GLM is a benign disease, it can severely impact the patient's normal life, causing physical and psychological trauma. However, few studies have included patients' subjective treatment experiences in the evaluation of treatment outcomes.

To date, there have been no studies comparing the efficacy of three treatment methods (surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy) in the same population of GLM patients. This study aims to compare the efficacy and patient satisfaction of these three treatment methods, with the hope of providing new insights for clinical treatment options.

Enrollment: 350 estimated patients

Sex: Female

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• non-lactating and aged 15-65 years
• histopathological confirmation of GLM
• normal liver and kidney function

Exclusion criteria

• lactating and pregnant women
• allergies to rifampin, isoniazid, or ethambutol
• concurrent malignant breast tumors
• severe underlying diseases
• other conditions deemed unsuitable by the investigator and
• refusal to participate in the study

Trial design

350 participants in 3 patient groups

surgery group

Description:

The patients underwent surgery

Treatment:

Procedure: Surgery

triple anti-tuberculosis drug therapy group

Description:

The patients were treated with triple anti-tuberculosis drugs

Treatment:

Drug: triple anti-tuberculosis drug

combination therapy group

Description:

The patients were treated with surgery first, and then took triple anti-tuberculosis drugs after surgery

Treatment:

Procedure: Surgery

Drug: triple anti-tuberculosis drug