Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis

NCT06565845 | Recruiting

• 1 other identifier: 2024182
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Granulomatous Mastitis

Keywords

Granulomatous lobular mastitis; surgical treatment; antituberculosis therapy; surgery combined with anti-tuberculosis therapy

Outcome Measures

Primary Outcomes (3)

• Differences in the cure rate of the three treatment modalities

  According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The cure rate was compared among the three groups.

  Baseline

• Differences in the recurrence rate of the three treatment modalities

  According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The recurrence rate was compared among the three groups.

  Baseline

• Differences in the incidence of adverse reactions of the three treatment modalities

  According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The incidence of adverse reactions was compared among the three groups.

  Baseline

Secondary Outcomes (2)

• Differences in the patient satisfaction score (points) of the three treatment modalities

  Baseline

• Differences in the treatment duration (months) of the three treatment modalities

  Baseline

Study Arms (3)

surgery group

The patients underwent surgery

Procedure: Surgery

triple anti-tuberculosis drug therapy group

The patients were treated with triple anti-tuberculosis drugs

Drug: triple anti-tuberculosis drug

combination therapy group

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

Procedure: Surgery; Drug: triple anti-tuberculosis drug

Interventions

Surgery PROCEDURE

patients underwent complete excision of the inflammatory breast tissue and some surrounding normal tissue under combined intravenous with inhalation anesthesia. Damaged skin was also removed.

combination therapy group; surgery group

triple anti-tuberculosis drug DRUG

Patients took oral rifampin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day).

combination therapy group; triple anti-tuberculosis drug therapy group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients with GLM who were treated at the Breast Surgery Department of the First Affiliated Hospital of Harbin Medical University were selected.Patients with GLM mostly present with unilateral disease, and the lesions can be located in any part of the breast. Arthritis and lower limb erythema nodosum are rare.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

Related Publications (4)

• Kessler E, Wolloch Y. Granulomatous mastitis: a lesion clinically simulating carcinoma. Am J Clin Pathol. 1972 Dec;58(6):642-6. doi: 10.1093/ajcp/58.6.642. No abstract available.

  PMID: 4674439 BACKGROUND

• 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. Correction: Management of granulomatous lobular mastitis: an international multidisciplinary consensus (2021 edition). Mil Med Res. 2022 Aug 23;9(1):47. doi: 10.1186/s40779-022-00408-w. No abstract available.

  PMID: 35999646 BACKGROUND

• Akcan A, Akyildiz H, Deneme MA, Akgun H, Aritas Y. Granulomatous lobular mastitis: a complex diagnostic and therapeutic problem. World J Surg. 2006 Aug;30(8):1403-9. doi: 10.1007/s00268-005-0476-0.

  PMID: 16847715 BACKGROUND

• Shang B, Zhang T, Liu C, Lu J, Cui C, Feng J, Zhou Y. Analysis of three treatment methods for granulomatous lobular mastitis: a retrospective study in a single center. Front Oncol. 2025 Apr 30;15:1588836. doi: 10.3389/fonc.2025.1588836. eCollection 2025.

  PMID: 40371221 DERIVED

MeSH Terms

Conditions

Granulomatous Mastitis

Interventions

Surgical Procedures, Operative

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

• Jing Feng

  First Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Central Study Contacts

Yi Zhou

CONTACT

+86-0451-85552102; lubj2001@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 22, 2024
• Study Start: August 19, 2024
• Primary Completion: September 19, 2024
• Study Completion: October 19, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)