ClinicalTrials.Veeva

Menu

Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery

W

Wuhan University

Status

Enrolling

Conditions

Refractory Granulomatous Lobular Mastitis

Treatments

Other: Intralesional triamcinolone injection
Other: No intralesional triamcinolone injection

Study type

Interventional

Funder types

Other

Identifiers

NCT05281419
2020091

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Intralesional triamcinolone injection with whole breast detection radical surgery
Experimental group
Treatment:
Other: Intralesional triamcinolone injection
Whole breast detection radical surgery
Active Comparator group
Treatment:
Other: No intralesional triamcinolone injection

Trial contacts and locations

1

Loading...

Central trial contact

Qianqian Yuan, MD.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems