Refractory Granulomatous Lobular Mastitis
Conditions
Keywords
Granulomatous lobular mastitis, Corticosteroids, Surgery
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.
Interventions
OTHERIntralesional triamcinolone injection
Injecting 40mg triamcinolone into the abscess cavity through the aspiration needle or drainage tube every 1 week
OTHERNo intralesional triamcinolone injection
No intralesional triamcinolone injection
Sponsors
Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
China
Contacts
Primary ContactQianqian Yuan, MD.
Outcome results
None listed