Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery

NCT ID: NCT05281419

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-12-31

Brief Summary

Granulomatous lobular mastitis (GLM) is a rare, chronic benign inflammatory disease of the breast, of unknown etiology. Pathologically, GLM typically manifests as non-caseating granulomatous lesions with leukomonocytes, lymphocytes, neutrophils and multinucleated giant cells, located in the center of breast lobules. With a rapidly increasing morbidity in the last two decades, GLM tends to occur in child-bearing women with a prolonged and recurrent course. Intralesional injection and topical corticosteroids can effectively reduce the side effects, especially in patients suffering from concomitant skin lesions (e.g., fistula, skin erosions, ulcers).For patients with diffuse disease, recurrence, or ineffective conservative treatment, wide local excision can be applied.

Conditions

Refractory Granulomatous Lobular Mastitis

Study Design

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

Study Groups

Intralesional triamcinolone injection with whole breast detection radical surgery

Group Type: EXPERIMENTAL

Intralesional triamcinolone injection

Intervention Type: OTHER

Injecting 40mg triamcinolone into the abscess cavity through the aspiration needle or drainage tube every 1 week

Whole breast detection radical surgery

Group Type: ACTIVE_COMPARATOR

No intralesional triamcinolone injection

Intervention Type: OTHER

No intralesional triamcinolone injection

Interventions

Intralesional triamcinolone injection

Injecting 40mg triamcinolone into the abscess cavity through the aspiration needle or drainage tube every 1 week

Intervention Type: OTHER

No intralesional triamcinolone injection

No intralesional triamcinolone injection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who were pathologically diagnosed as refractory granulomatous lobular mastitis.
• Lesions are extensively distributed to more than three quadrants or with abscesses, sinus, fistula and persistent wound infection (skin ulceration and pus).
• Patients voluntarily participate in studies with informed consent.

Exclusion Criteria

• History of breast surgery.
• Patients who choose conservative treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Gaosong Wu, Ph D, MD

Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qianqian Yuan

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qianqian Yuan, MD.

Role: CONTACT

Yuanqq11@whu.edu.cn

13026322297

Facility Contacts

Qianqian Yuan, MD.

Role: primary

Yuanqq11@whu.edu.cn

13026322297

Other Identifiers

2020091

Identifier Type: -

Identifier Source: org_study_id