MedPath

Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery

Not Applicable
Recruiting
Conditions
Refractory Granulomatous Lobular Mastitis
Interventions
Other: Intralesional triamcinolone injection
Other: No intralesional triamcinolone injection
Registration Number
NCT05281419
Lead Sponsor
Wuhan University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
100
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intralesional triamcinolone injection with whole breast detection radical surgeryIntralesional triamcinolone injection-
Whole breast detection radical surgeryNo intralesional triamcinolone injection-
Primary Outcome Measures
NameTimeMethod
Recovery rateUp to two years

Disappearance of conscious symptoms: disappearance of pain and swelling sensations; disappearance of corresponding preoperative signs: clinically untouchable proto-inflammatory lesions, healing of wounds, ulcers, fistulas, sinus tracts, etc., no redness and rupture of the skin, no discharge of nipples, no inverted, no deformation, no upper and lower extremity nodular erythema and joint pain; recovery of imaging performance: no obvious hypoechondria under ultrasound, irregular masses without echo or mixed echoes, no preoperative dense punctate echoes, tubular echoes, abscesses or necrosis, liquefaction areas. Failure to meet the above criteria and maintain for more than one year without recurrence is defined as cure.

Recurrence rateUp to one year

Intraoperative inflammatory changes in the ipsilateral breast within one year of surgery, with lumps, abscesses, or fistula formation, with or without erythema nodosum of the upper and lower extremities and joint pain

Secondary Outcome Measures
NameTimeMethod
Healing of incisionUp to six months

Defined as the time from the first day after surgery to the healing of the surgical incision, the wound surface is dry, no exudation, and no surgical incision complications occurs.

Complications of surgical incisionUp to one year

Delayed incision healing, bleeding, hematoma, infection, fat liquefaction

Scores of breast shape and cosmetic effect after surgeryUp to six months

Standards of Harris

Degree of satisfactionUp to one year

The postoperative shape of breast, treatment time, postoperative pain and impact on life were divided into 5 grades, 1 point was the most serious, 5 points were no impact, the scores were added together to obtain the final score, and the satisfaction survey was conducted on patients every 3 months.

Trial Locations

Locations (1)

Qianqian Yuan

🇨🇳

Wuhan, Hubei, China

© Copyright 2025. All Rights Reserved by MedPath