Idiopathic Granulomatous Mastitis Clinical Trial
— IGM-COMBOOfficial title:
The Effect of the Combination of Excision and Intraoperative Steroid Administration in Idiopathic Granulomatous Mastitis
NCT number | NCT05361629 |
Other study ID # | MF 22-02 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 16, 2022 |
Est. completion date | September 2023 |
Verified date | May 2022 |
Source | Baskent University |
Contact | Ozgur Aytac, MD |
Phone | 905326529343 |
oaytac[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
After breast cancer, diopathic Granulomatous Mastitis (IGM) is among the breast diseases that bother patients and clinicians the most. Countries with a coast to the Mediterranean, especially our country, are the most common geography of this disease. For this reason, a significant part of the important scientific publications about IGM in the last 3-4 decades are from the countries of this geography and mainly from our country. The paradigm of whether IGM should be treated medically or surgically is still a matter of debate. Today, effective treatment results can be achieved with medical treatments, and local drug applications are finding an increasing application area in order to reduce the systemic drug level due to the side effects often seen in this process. As in the centers dealing with breast diseases intensively in our country, patients are treated in our center both by systemic and local means. Within the body of the Turkish Breast Diseases Federation, after the plans made with the employees of the leading breast centers of the International Breast Health Working Group International planned to start a recording study to observe the activity between, local treatment in the lesion without surgical treatment with systemic treatment in IGM treatment and local treatment together with surgical treatment.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 2023 |
Est. primary completion date | April 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients diagnosed with IGM histopathologically - Patients in groups A, B and C according to clinical classification - Ultrasonographically; Patients with leaf-like hypoechoic type, localized abscess type, and localized hypoechoic mass type mastitis Exclusion Criteria: - Patients diagnosed with tumor after biopsy - Those with TB PCR (+) - Presence of clinically widespread abscess and cellulite (group D patients) - Ultrasonographically; diffuse diffuse type - Pregnancy - Breastfeeding period |
Country | Name | City | State |
---|---|---|---|
Turkey | Baskent University Adana Teaching Hospital | Adana | Yuregir |
Lead Sponsor | Collaborator |
---|---|
Baskent University |
Turkey,
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 granulom — View Citation
Ma X, Min X, Yao C. Different Treatments for Granulomatous Lobular Mastitis: A Systematic Review and Meta-Analysis. Breast Care (Basel). 2020 Feb;15(1):60-66. doi: 10.1159/000501498. Epub 2019 Jul 10. — View Citation
Wang Y, Song J, Tu Y, Chen C, Sun S. Minimally invasive comprehensive treatment for granulomatous lobular mastitis. BMC Surg. 2020 Feb 22;20(1):34. doi: 10.1186/s12893-020-00696-w. — View Citation
Zhou F, Liu L, Liu L, Yu L, Wang F, Xiang Y, Zheng C, Huang S, Cai H, Yu Z. Comparison of Conservative versus Surgical Treatment Protocols in Treating Idiopathic Granulomatous Mastitis: A Meta-Analysis. Breast Care (Basel). 2020 Aug;15(4):415-420. doi: 10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of excision and intraoperative steroid administration to the cavity in Idiopathic Granulomatous Mastitis. | The effect of the combination of excision and single dose intraoperative steroid administration to the cavity on outcome in Idiopathic Granulomatous Mastitis. | one year | |
Secondary | Rate of side effects in patients who received intralesional steroid | Comparison of side effect rates in patients treated with intralesional steroids +/- low-dose oral steroids and/or topical steroids. | one year | |
Secondary | Correlation of treatment modality and serum cortisol levels. | Correlation of treatment modality and serum cortisol levels in patients treated with intralesional steroids +/- low-dose oral steroids and/or topical steroids. | one year |
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