Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Refractory Granulomatous Lobular Mastitis

Intervention / Treatment
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* Other: Intralesional triamcinolone injection
* Other: No intralesional triamcinolone injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intralesional triamcinolone injection with whole breast detection radical surgery<br> | Other: Intralesional triamcinolone injection<br>* Injecting 40mg triamcinolone into the abscess cavity through the aspiration needle or drainage tube every 1 week<br>|
| Active Comparator: Whole breast detection radical surgery<br> | Other: No intralesional triamcinolone injection<br>* No intralesional triamcinolone injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate | 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. | Up to two years | 
| Recurrence rate | 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 | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of breast shape and cosmetic effect after surgery | Standards of Harris | Up to six months | 
| Degree of satisfaction | 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. | Up to one year | 
| Healing of incision | 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. | Up to six months | 
| Complications of surgical incision | Delayed incision healing, bleeding, hematoma, infection, fat liquefaction | Up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Granulomatous lobular mastitis, Corticosteroids, Surgery