Observation Alone for Mild Non-Lactational Mastitis

NCT ID: NCT06665399

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-11
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this observational study is to investigate the disease progression rate and timing in patients with mild Non-Lactational Granulomatous Lobular / Periductal Mastitis (NL-GLM/PDM) during follow-up with observation alone strategy. The main questions it aims to answer are: What is the rate of disease progression in mild NL-GLM/PDM patients under observation, and what clinical and pathological factors are associated with this progression? Participants with diagnosis of mild NL-GLM/PDM will be monitored over a specified period, with data collected on their clinical outcomes and relevant factors influencing disease progression.

Detailed Description

Non-Lactational Granulomatous Lobular / Periductal Mastitis (NL-GLM/PDM) is an inflammatory breast disease of unclear etiology, primarily characterized by the presence of breast masses. A variety of treatment approaches, including intralesional injection, ductal lavage therapy, or corticosteroids had been proposed. Recently, an increasing number of studies have demonstrated that an observation and follow-up strategy for mild cases can yield comparable efficacy. An international consensus recommends that this observation strategy may serve as a first-line treatment approach for mild NL-GLM patients, with additional therapies implemented only upon disease progression.However, in clinical practice, we have observed that some patients with mild NL-GLM/PDM experience disease progression during the observation period, necessitating further treatment. The proportion of this population and the specifics of their disease progression remain unknown. Additionally, the clinical and pathological factors associated with disease progression during observation have not been previously studied. This research aims to conduct a single-center, single-arm, prospective cohort study to investigate the rate and timing of disease progression in mild NL-GLM/PDM during observation, as well as to explore the clinical and pathological factors related to progression. The findings will provide further guidance for subsequent research and clinical practice.

Conditions

Granulomatous Mastitis; Mastitis Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation

In this study, the definition of "observation" is that participants cannot receive the following treatments currently considered to have a clear efficacy for NL-GLM/PDM.

Observation

Intervention Type: OTHER

In this study, the definition of "observation" is that participants cannot receive the following treatments currently considered to have a clear efficacy for NL-GLM/PDM, including surgical treatments (minimally invasive excision or open excision, incision and drainage), ultrasound-guided aspiration, oral corticosteroid therapy, antibiotic treatment, anti-tuberculosis therapy, or ductal lavage therapy. As symptomatic management for pain, the use of NSAIDs is permitted. Additionally, for patients with fistulas or skin lesions, routine wound care is also allowed. These two interventions are not considered as receiving treatment intervention in this study.

Interventions

Observation

In this study, the definition of "observation" is that participants cannot receive the following treatments currently considered to have a clear efficacy for NL-GLM/PDM, including surgical treatments (minimally invasive excision or open excision, incision and drainage), ultrasound-guided aspiration, oral corticosteroid therapy, antibiotic treatment, anti-tuberculosis therapy, or ductal lavage therapy. As symptomatic management for pain, the use of NSAIDs is permitted. Additionally, for patients with fistulas or skin lesions, routine wound care is also allowed. These two interventions are not considered as receiving treatment intervention in this study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Female, aged 18 to 65 years;

2. Clinically diagnosed with possible non-lactational (more than 6 months since stopping breastfeeding) granulomatous lobular mastitis or periductal mastitis.

3. Mscore ≤ 3 points;

4. Patients with ultrasound findings suggesting localized breast abscess formation must have undergone abscess drainage before enrollment;

5. After education, participants should have a strong willingness for observation and follow-up, and, after discussing with the primary physician, jointly decide to proceed with observation and follow-up;

6. Signed informed consent form.

Exclusion Criteria

1. Patients with confirmed or suspected breast malignancy;

2. Patients with bilateral mastitis (including those with bilateral simultaneous onset and those with sequential onset of non-lactational granulomatous mastitis);

3. Pregnant patients who are currently in the gestation period;

4. Patients who have had non-lactational mastitis in the same breast within the past year and have undergone treatments such as surgery, oral corticosteroids (for more than 2 weeks), anti-tuberculosis treatment (for more than 2 weeks), or ductal lavage therapy.

5. Patients who received surgery, oral corticosteroids, or anti-tuberculosis treatment for the non-lactational mastitis of the ipsilateral breast within 2 weeks before enrollment.

• 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

Vice Director of Dept. of Breast Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Shenshan Medical Center, Sun Yat-sen Memorial Hospital

Shanwei, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kai Chen, MD

Role: CONTACT

chenkai23@mail.sysu.edu.cn

86-020-34070463

Facility Contacts

Kai Chen, MD

Role: primary

chenkai23@mail.sysu.edu.cn

86-20-34070463

Liling Zhu

Role: primary

zhuliling@mail.sysu.edu.cn

86-0660-3863000

References

Yuan QQ, Xiao SY, Farouk O, Du YT, Sheybani F, Tan QT, Akbulut S, Cetin K, Alikhassi A, Yaghan RJ, Durur-Subasi I, Altintoprak F, Eom TI, Alper F, Hasbahceci M, Martinez-Ramos D, Oztekin PS, Kwong A, Pluguez-Turull CW, Brownson KE, Chandanwale S, Habibi M, Lan LY, Zhou R, Zeng XT, Bai J, Bai JW, Chen QR, Chen X, Zha XM, Dai WJ, Dai ZJ, Feng QY, Gao QJ, Gao RF, Han BS, Hou JX, Hou W, Liao HY, Luo H, Liu ZR, Lu JH, Luo B, Ma XP, Qian J, Qin JY, Wei W, Wei G, Xu LY, Xue HC, Yang HW, Yang WG, Zhang CJ, Zhang F, Zhang GX, Zhang SK, Zhang SQ, Zhang YQ, Zhang YP, Zhang SC, Zhao DW, Zheng XM, Zheng LW, Xu GR, Zhou WB, Wu GS. Management of granulomatous lobular mastitis: an international multidisciplinary consensus (2021 edition). Mil Med Res. 2022 Apr 26;9(1):20. doi: 10.1186/s40779-022-00380-5.

Reference Type: BACKGROUND

PMID: 35473758 (View on PubMed)

Other Identifiers

SYSKY-2024-708-01

Identifier Type: -

Identifier Source: org_study_id