NCT05281419

Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery

Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery in Treating Refractory Granulomatous Lobular Mastitis: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wuhan University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Intralesional triamcinolone injection	Injecting 40mg triamcinolone into the abscess cavity through the aspiration needle or drainage tube every 1 week
OTHER	No intralesional triamcinolone injection	No intralesional triamcinolone injection

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-03-16
• Last updated: 2022-03-16

Locations

1 site across 1 country: China