Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery
- Conditions
- Refractory Granulomatous Lobular Mastitis
- Interventions
- Other: Intralesional triamcinolone injectionOther: 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
- 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.
- History of breast surgery.
- Patients who choose conservative treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intralesional triamcinolone injection with whole breast detection radical surgery Intralesional triamcinolone injection - Whole breast detection radical surgery No intralesional triamcinolone injection -
- Primary Outcome Measures
Name Time Method Recovery rate Up 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 rate Up 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
Name Time Method Healing of incision Up 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 incision Up to one year Delayed incision healing, bleeding, hematoma, infection, fat liquefaction
Scores of breast shape and cosmetic effect after surgery Up to six months Standards of Harris
Degree of satisfaction Up 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