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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional triamcinolone injection with whole breast detection radical surgery | Experimental |
| |
| Whole breast detection radical surgery | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional triamcinolone injection | Other | Injecting 40mg triamcinolone into the abscess cavity through the aspiration needle or drainage tube every 1 week |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qianqian Yuan, MD. | Contact | 13026322297 | Yuanqq11@whu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qianqian Yuan | Recruiting | Wuhan | Hubei | 430071 | China |
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| No intralesional triamcinolone injection | Other | No intralesional triamcinolone injection |
|
| 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 |