Ultrasonography Features of the Salivary Glands in Patient With Systemic Sclerosis: Comparison With Gougerot-Sjogren Syndrome and Sicca Asthenia Polyalgia Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Jousse-Joulin ultrasonography score
研究概览
简要总结
Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). Several criteria have been validated to classify the SS but require a labial salivary gland biopsy, invasive act which complications can sometimes be reported (hematoma, lip sensory defect).
Several scores based on the evaluation of the ultrasound homogeneity of the salivary glands were developed but no studies have evaluated ultrasound abnormalities of salivary glands in patients with systemic sclerosis.
详细描述
Descriptive explorative study of three population showing sicca symptoms (Systemic sclerosis, Gougerot-Sjogren syndrome, Sicca-Asthenia-Polyalgia syndrome).
Patient will be enrolled in the rheumatology department of University hospital of Clermont-Ferrand (France).
Salivary glands ultrasonography will be performed on all patients enrolled by the same expert and blinded to the diagnosis of the patient. Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Systemic sclerosis diagnosis established by a rheumatologist and met ACR 2012 criteria
- •Or primary Gougerot-Sjogren patient who met American-European Consensus Group (AECG) classification criteria.
- •Or patient presenting a sicca syndrome but not met Gougerot-Sjogren criteria
排除标准
- •History of radiotherapy on face and neck
- •Infection such as VIH or Hepatitis C
- •Sarcoidosis
- •Wearing contact lenses
- •Hyper IgG4 syndrome
结局指标
主要结局
Jousse-Joulin ultrasonography score
时间窗: the day of inclusion
Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.
次要结局
- Ultrasonography score equal or higher than 2 on at least one salivary gland(the day of inclusion)
- Ultrasonography score equal or higher than 3 on at least one salivary gland(the day of inclusion)
- Global ultrasonography score higher than 6/16(the day of inclusion)
- Salivary glands area(the day of inclusion)