RElevance of UltraSonography for Assessing Salivary Gland Involvement in Systemic Sclerosis (SSc)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Ultrasonography characteristics of major salivary glands
研究概览
简要总结
As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force Impulse)) in SSc patients could also constitute a relevant method to assess the potential alterations of echostructure of major salivary glands and the fibrosis of Salivary Glands in this disease.
详细描述
Systemic sclerosis (SSc) is a rare autoimmune chronic disorder characterised by vascular hyper-reactivity and fibrosis of the skin as well as internal organs. Intimal hyperplasia, endothelial dysfunction and occlusive vasculopathy are the underlying basis of these chronic vascular damages. The expression of the vasculopathy especially includes Raynaud phenomenon (RP), digital ulcers (DUs), gastro-intestinal involvement and pulmonary arterial hypertension (PAH). Sicca syndrome is clinically characterised by dryness of the eyes (xerophthalmia) and mouth (xerostomia). The prevalence of sicca symptoms is up to 70% in prospective series of SSc patients. Sicca syndrome is supposed to be primarily related to glandular fibrosis. The prevalence of primary Sjögren Syndrome (pSS) among SSc patients, as defined by the American-European Consensus Group criteria is around 15%. Sicca syndrome is therefore a frequent feature in SSc and constitutes an important cause of quality of life's impairment in SSc If studies have already evaluated clinical and histological alterations of minor salivary glands secondary to sicca syndrome in SSc , only few studies used the recent ACR(American College of Rheumatology) 2013 classification criteria for SSc to select patients. SGUS(Salivary Gland UltraSonography) evaluation in SSc has never been assessed to date. Potential alterations of MSG (Major Salivary Gland) echostructure in SSc have never been described to date. The performances and reliability of SGUS to assessed MSG involvement in SSc are still to be determined. As fibrosis of salivary glands is supposed to be the main mechanism involved in SSc-associated sicca syndrome, measuring salivary-gland elasticity using ARFI-ultrasonography in SSc patients could also constitute a relevant method to assess the fibrosis of MSG in this disease. A cross-sectional pilot study is therefore needed to explore these relevant questions about sicca syndrome in SSc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The examiner performin the evaluation of ultrasound features of the main salivary glands will not have acess at the first part of patient evaluation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over eighteen years old;
- •Fulfilling 2013 ACR classification criteria for Systemic sclerosis (Van den Hoogen et al. 2013);
- •60 patients with subjective sicca symptoms reported by a standardised questionnaire (Vitali C et al. 2002);
- •15 patients without sicca symptoms;
- •Who has signed an informed consent
- •Benefiting from a social security scheme
排除标准
- •Treatment: current (or in the past 6 months) immunosuppressive treatment by rituximab or cyclophosphamide (representing less than 5% of SSc patients in the investigator's centres);
- •Current (or in the past 6 months) treatment with drugs with anti-cholinergic properties (Selective Serotonin Reuptake Inhibitors and anti-histaminic inhibitors (hydroxyzine));
- •Current treatment with antiplatelet aggregates
- •Anti-vitamin K treatment (increasing risk of bleeding during minor salivary gland biopsy); and oral anti-coagulant
- •Known abnormal coagulation (prolonged aPPT(activated partial thromboplastin time) and / or PT (Prothrombin time ( <70%)), or known thrombocytopenia (<150,000 platelets / mm3)
- •Known secondary sicca symptoms : history of head-and-neck radiotherapy, hepatitis C infection, AIDS, sarcoidosis, amyloidosis, graft-vs-host disease and IgG4(Isotype's immunoGlobulin G4)-related disease;
- •Pregnancy or breastfeeding mothers;
- •Known intolerance/allergy to xylocain injection;
- •Adults legally protected (under judicial protection, guardianship, or supervision), inability to consent.
结局指标
主要结局
Ultrasonography characteristics of major salivary glands
时间窗: up to six months (at evaluation visit)
Ultrasonography characteristics of major salivary glands based on Salaffi's composite score. each MSG will be scored as followed: * grade 0 = normal homogeneous glands; * grade 1 = Homogenous borders, slightly heterogeneous parenchyma, * grade 2 = Homogenous borders, multiple hypoechogenic areas measuring \< 2 mm, * grade 3 = multiple hypoechogenic areas measuring 2-6 mm or irregular borders or invisible posterior part of the gland; * grade 4 = unstructured glandular parenchyma with multiple hypoechogenic areas measuring \>6 mm or calcifications with echogenic bands. In each patient, 4 grades can be obtained (1 grade per gland); the sum of these 4 grades (range 0-16) will be the Salaffi's score. A score of 0 has the best outcome, of 16 the worse
次要结局
- Variants of the Salaffi score(up to six months (evaluation visit))
- Biopsy of the minor salivary glands(up to six months (evaluation visit))
- Evaluation of the presence or absence of objective criteria of Sjogren(up to six months (evaluation visit))
- Clinical evaluation of systemic scleroderma lesions(up to six months (evaluation visit))