Granulomatous Mastitis Clinical Trial
Official title:
Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis: a Multicenter, Randomized, Open-labelled, Non-inferior Trial.
Verified date | January 2024 |
Source | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A single-arm, proof-of-concept trial has shown the safety and efficacy of ductal lavage as a treatment for idiopathic granulomatous mastitis patients (Manuscript accepted in Journal of Surgical Research 2018). In this multicenter, randomized, open-labeled, non-inferior trial, the investigators are going to enroll eligible granulomatous mastitis patients and randomized them into ductal lavage versus. corticosteroids therapy group. The primary endpoint of this study is the complete clinical response rate at 1 year after the enrollment. The aim of this study is to provide evidence for the management of idiopathic granulomatous mastitis patients .
Status | Completed |
Enrollment | 140 |
Est. completion date | April 21, 2023 |
Est. primary completion date | April 21, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Female, age between 18 and 65 years old. - Inform consent signed. - Clinical diagnosis of non-lactating mastitis, defined as mastitis occurred more than 1 month after the cessation of lactation. - Clinical and pathological diagnosis of idiopathic granulomatous mastitis. - Never receive surgical treatments, or corticosteroids therapy after the cessation of lactation. Core needle biopsy is allowed. - Good health, judged by clinicians, to receive ductal lavage. - M score >=2 Exclusion Criteria: - Grade III inverted nipple(Plastic. Reconstruction. Surgery. 104: 389, 1999.) - Lactational mastitis patients. - Bilateral IGM patients. - Clinically diagnosis of periductal mastitis. - Pathological diagnosis of breast carcinoma. - Pregnant women. - Evidences suggest possible diagnosis of SLE(systemic lupus erythematosus), rheumatic disorders or other systematic auto-immune diseases. - Evidences suggest possible diagnosis of tuberculosis. - Evidences suggest possible diagnosis of fungus infection of the breast - History of breast trauma. - History of taking oral corticosteroids or anti-tuberculosis treatment. - Imaging examinations indicates foreign objects retained in the breast - Presence of sepsis or severe inflammation caused by IGM, for which surgery is likely required. - Patients with inappropriate coagulation function, cardiac function, pulmonary function, liver and renal function, that clinicians judges as not suitable to participate in this study. |
Country | Name | City | State |
---|---|---|---|
China | Jiangmen Maternal and Child Health Care Population & Family Planning Service Center | Jiangmen | Guangdong |
China | Lian Jiang People'S Hospital | Lianjiang | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
China,
Chen K, Zhu L, Hu T, Tan C, Zhang J, Zeng M, Li S, Song E. Ductal Lavage for Patients With Nonlactational Mastitis: A Single-Arm, Proof-of-Concept Trial. J Surg Res. 2019 Mar;235:440-446. doi: 10.1016/j.jss.2018.10.023. Epub 2018 Nov 19. — View Citation
Hu T, Li S, Huang H, Huang H, Tan L, Chen Y, Deng H, Wu J, Zhu L, Zhang J, Su F, Chen K. Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol. BMJ Open. 2020 Oct 10;10(10):e036643. doi: 10.1136/bmjopen-2019-036643. Erratum In: BMJ Open. 2022 Aug 25;12(8):e036643corr1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Clinical Response(cCR) | The proportion of patients that achieve M-score <=1 at 1 year after the treatment. | 1 year since randomization | |
Secondary | Time to cCR | The median time to cCR since the randomization. | 1 year since randomization | |
Secondary | Treatment failure (TF) rate | The proportion of patients with TF at 1 year since the randomization. The TF status is defined as the following:
If the patient has M-score>=6 before randomization, TF is defined as the M-score still remains >=6 at one month since the randomization. If the patient has M-score between 4 and 5 before randomization, TF is defined as the M-score still remains at >=4, and never have been lower than 4. If the patient has M-score<4 before randomization, and never reaches cCR since randomization, and during follow-up, the M-score is found to be >5 and last for one month. |
1 year since randomization | |
Secondary | Relapse rate | The proportion of patients that had M-score>4 among those patients who achieved cCR. | 1 year since randomization | |
Secondary | Adverse events | Pre-defined and any other unexpected adverse events would be recorded and compared between the two arms. | 1 year since randomization | |
Secondary | Protocol compliance rate | The proportion of patients who received the treatment protocol. | 1 year since randomization |
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