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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.

ABSTRACT: INTRODUCTION:The ideal treatment for idiopathic granulomatous mastitis (IGM) remains unclear. In a prospective, single-centre, pilot study, we reported that ductal lavage treatment for non-lactational mastitis patients had a 1-year clinical complete response (cCR) rate of >90%, without any significant adverse events. Thus, in this multicentre, randomised, open-label, non-inferiority trial, we will aim to compare the effectiveness and safety of ductal lavage vs oral corticosteroids as the first-line treatment for patients with IGM. METHODS AND ANALYSIS:The trial will be conducted at the Breast Tumor Center of Sun Yat-sen Memorial Hospital in China and at least at one participating regional centre. We plan to recruit 140 eligible IGM patients who will be randomised into the ductal lavage group or oral corticosteroid group with a 1:1 ratio. The patients in the oral corticosteroid group will receive meprednisone or prednisone for 6 months. The patients in the ductal lavage group will receive ductal lavage and breast massage, as previously reported. All the participants will be followed up at the clinic for 1 year post randomisation. The primary endpoint of this trial will be the 1-year cCR rate, and the secondary endpoints will include the time to cCR, treatment failure rate, relapse rate and protocol compliance rate. The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%. ETHICS AND DISSEMINATION:The ethics committee of Sun Yat-sen Memorial Hospital at Sun Yat-sen University approved the study (2018-Lun-Shen-Yan-No. 30). The results of the trial will be communicated to the participating primary care practices, published in international journals and presented at international clinical and scientific conferences. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Registry (NCT03724903); Pre-results.

SUBMITTER: Hu T

PROVIDER: S-EPMC7552910 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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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.

Hu Tingting T Li Shunrong S Huang Heng H Huang Hui H Tan Luyuan L Chen Yanbo Y Deng Heran H Wu Jiannan J Zhu Liling L Zhang Jian J Su Fengxi F Chen Kai K

BMJ open 20201010 10

<h4>Introduction</h4>The ideal treatment for idiopathic granulomatous mastitis (IGM) remains unclear. In a prospective, single-centre, pilot study, we reported that ductal lavage treatment for non-lactational mastitis patients had a 1-year clinical complete response (cCR) rate of >90%, without any significant adverse events. Thus, in this multicentre, randomised, open-label, non-inferiority trial, we will aim to compare the effectiveness and safety of ductal lavage vs oral corticosteroids as the ...[more]

PMID: 33039992

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Project description:BackgroundIdiopathic granulomatous mastitis (IGM) is an uncommon benign chronic inflammatory disease which can clinically and radiographically mimic abscess or breast cancer. Definitive diagnosis was made by histopathology and exclusion of an identifying etiology. Optimal treatment has not been yet established. The aim of this study was to report and describe the clinical signs, radiological findings, managements, clinical course, and clinical outcomes after treatment of IGM.MethodWe retrospectively studied IGM medical records of 44 patients in our institute collected from March 1990 to October 2016. The patient characteristics, clinical presentations, radiological findings, microbiological workups, tissue pathology, treatment modalities, outcomes, and follow-up data were reviewed and analyzed. The success rate, recurrence rate and time-to-healing were compared focusing on the treatment modalities to find the proper treatments for IGM patient.ResultsForty-four patients were diagnosed as IGM. The median follow-up time was 20.73 months ranging from 1.26 to 118.8 months while the median time of the diagnosis was 21 days ranging from 2 to 246 days. Due to the follow-up period, only thirty-nine patient data were used for the analysis. In the first setting, 30 patients were treated by surgery, 6 patients were treated by using steroid while other 3 patients were treated by other different treatments. Only 25 from 39 patients (64.10%) were cured by the first modality. The overall median time-to-healing was 84 days while the medians of time-to-healing treated by surgery, steroid and the rest were 75, 114.5, and 238 days respectively. The surgical treatment had the shortest time-to-healing but not statistically significant (p?=?0.23). Thirteen patients out of twenty-five (52%) had wound complications after performing an excision. Lastly, five patients out of thirty-nine (12.82%) had recurrence.ConclusionIGM is an uncommon benign disease which is hardly distinguished from malignancy. There is not a significant difference among treatment modalities in term of time-to-healing and recurrence of disease. The result shows that surgery is outperformed by the shortest healing time. However, the surgical treatment must be chosen with careful due to high rate of wound complications. Multimodality treatment is recommended as the proper treatments for IGM patient.

Project description:Background:Iidiopathic granulomatous mastitis (IGM) is stereotypically described as a mysterious entity that mimics breast carcinoma imposing management challenges. In 2002, we established a multidisciplinary team to treat patients with IGM. This study aimed to evaluate the role of this team in improving patient outcomes. Also, a review of literature is provided to highlight recent disease trends. Patients and Methods. Pertinent data for 44 patients treated for IGM from 2002 to 2018 were analyzed and compared to data prior to 2002. Results:Mean age at diagnosis was 37.9 years?±?6.4. The diagnosis of IGM was confirmed by True-cut biopsy (TCB), Frozen section (FS), and surgical biopsy in 70.5%, 25%, and 4.5% of patients, respectively. FS was used to assess the resection margins in three patients. Suspicion for malignancy was raised in one out of 39 ultrasound reports, and one out of 20 mammography reports. Wide local excision was the main treatment modality (95.5%). 19 patients (43.2%) received corticosteroids. Prior to 2002, IGM was only recognized after surgical resection with a 71% initial false impression of carcinoma. After 2002, the initial false clinical impression of carcinoma dropped to 29.5%. Recurrence rate was 31.82%. Younger age at diagnosis was significantly associated with recurrence (? 2?=?5.598; p = 0.018). Chi-square analysis showed no significant association between BMI and recurrence (? 2?=?0.776; p = 0.678). Conclusion:The establishment of a multidisciplinary team for IGM was associated with a reduced erroneous impression of breast cancer, and a reduced false positive radiological diagnosis of breast carcinoma. FS was a useful confirmatory procedure. Our series included the first case of a diffuse papular rash as a systemic manifestation of IGM. Recent literature indicates that IGM is changing its face. IGM is being reported in all age groups, and even in males. The clinical manifestations have markedly expanded. Diagnosis by TCB has replaced blind surgical excision. More data regarding predictors of recurrence is accumulating.

Project description:Background:The exact etiology and pathogenesis of granulomatous lobular mastitis (GLM) are yet to be illuminated. This study aimed to investigate CD68, CD163-positive M2 macrophages, CD57-positive natural killer (NK) cells, and IgG4 in GLM lesion tissue to explore their correlation with the occurrence and clinical features of GLM. Methods:Surgical pathologic specimens of GLM were collected from patients admitted to Hunan Provincial People's Hospital between October, 2014 and October 2015. Based on the postoperative pathological diagnosis, the tissues were divided into 3 groups: the experimental group (GLM, n=36), control group 1 (plasma cell mastitis, PCM, n=17), and control group 2 (breast cystic hyperplasia, n=10). Immunohistochemical staining was carried out using Elivision super testing to detect CD68, CD163, CD57, and IgG4 expression in the pathological tissue samples. The relationship between clinical parameters, including age, reproductive condition, nipple retraction, and tumor size, and the expressions of CD68, CD163, CD57, and IgG4 was analyzed. Results:There was no obvious difference in the levels of CD68, CD163, and CD57 expression between the GLM group and the PCM group, although both groups had higher expression levels of expression than the breast cystic hyperplasia group (P<0.05). In the GLM group, the expression level of CD57 at 2 weeks-3 months was significantly higher than at ?2 weeks (P<0.05). The expression level of CD57 in PCM patients >2 years after lactation was significantly higher than in patients ?2 years after lactation (P<0.05). The level of IgG4 expression in GLM patients with nipple retraction was significantly higher than in those without nipple retraction (P<0.05). Conclusions:Inflammatory cells are closely linked to the occurrence of GLM and PCM. In our study, both the GLM and PCM groups had low expression of IgG4, but the expression level of IgG4 in GLM patients with inverted nipples was significantly higher than that in patients without inverted nipples. This suggests that there may be two different clinical subtypes of GLM. Furthermore, our research also found that NK cells can provide a basis for GLM clinical staging.

Project description:While the combination of nifurtimox and eflornithine (NECT) is currently recommended for the treatment of the late stage human African trypansomiasis (HAT), single-agent eflornithine was still the treatment of choice when this trial commenced. This study intended to provide supportive evidence to complement previous trials.A multi-centre randomised, open-label, non-inferiority trial was carried out in the Trypanosoma brucei gambiense endemic districts of North-Western Uganda to compare the efficacy and safety of NECT (200 mg/kg eflornithine infusions every 12 h for 7 days and 8 hourly oral nifurtimox at 5 mg/kg for 10 days) to the standard eflornithine regimen (6 hourly at 100 mg/kg for 14 days). The primary endpoint was the cure rate, determined as the proportion of patients alive and without laboratory signs of infection at 18 months post-treatment, with no demonstrated trypanosomes in the cerebrospinal fluid (CSF), blood or lymph node aspirates, and CSF white blood cell count <?20 /?l. The non-inferiority margin was set at 10%.One hundred and nine patients were enrolled; all contributed to the intent-to-treat (ITT), modified intent-to-treat (mITT) and safety populations, while 105 constituted the per-protocol population (PP). The cure rate was 90.9% for NECT and 88.9% for eflornithine in the ITT and mITT populations; the same was 90.6 and 88.5%, respectively in the PP population. Non-inferiority was demonstrated for NECT in all populations: differences in cure rates were 0.02 (95% CI: -0.07-0.11) and 0.02 (95% CI: -0.08-0.12) respectively. Two patients died while on treatment (1 in each arm), and 3 more during follow-up in the NECT arm. No difference was found between the two arms for the secondary efficacy and safety parameters. A meta-analysis involving several studies demonstrated non-inferiority of NECT to eflornithine monotherapy.These results confirm findings of earlier trials and support implementation of NECT as first-line treatment for late stage T. b. gambiense HAT. The overall risk difference for cure between NECT and eflornithine between this and two previous randomised controlled trials is 0.03 (95% CI: -0.02-0.08). The NECT regimen is simpler, safer, shorter and less expensive than single-agent DFMO.ISRCTN ISRCTN03148609 (registered 18 April 2008).

Dataset Information

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.

Publications

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.

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