Combined Intralesional Triamcinolone Injection With Whole Breast Detection Radical Surgery

Refractory Granulomatous Lobular Mastitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281419
• Other study ID #: 2020091
• Status: Recruiting
• Phase: N/A
• 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
• 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.

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