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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05281419
Other study ID # 2020091
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date December 31, 2024

Study information

Verified date March 2022
Source Wuhan University
Contact Qianqian Yuan, MD.
Phone 13026322297
Email Yuanqq11@whu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms

  • Mastitis
  • Refractory Granulomatous Lobular Mastitis

Intervention

Other:
Intralesional triamcinolone injection
Injecting 40mg triamcinolone into the abscess cavity through the aspiration needle or drainage tube every 1 week
No intralesional triamcinolone injection
No intralesional triamcinolone injection

Locations

Country Name City State
China Qianqian Yuan Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Scores of breast shape and cosmetic effect after surgery Standards of Harris Up to six months
Secondary 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
Secondary 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
Secondary Complications of surgical incision Delayed incision healing, bleeding, hematoma, infection, fat liquefaction Up to one year
See also
  Status Clinical Trial Phase
Recruiting NCT04637711 - Surgical Intervention for Refractory Granulomatous Lobular Mastitis N/A