Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change, compared to baseline and to a non-treatment control group, in unstimulated whole mouth saliva in ml/min after sialoendoscopic treatment
研究概览
简要总结
Sjögren's syndrome (SS) is an autoimmune inflammatory disorder of the exocrine glands. It particularly affects the lacrimal and salivary glands. Severe dry mouth and eyes are frequently reported as presenting symptoms. These symptoms are in many cases accompanied by nonspecific symptoms, such as malaise and fatigue. In addition, extraglandular manifestations, like purpura, polyneuropathy, and arthritis, can be present. SS affects mainly women with a female/male ratio of 9:1 and can occur at all ages. Due to the irreversible damage to the saliva producing cells, the quantity and quality of saliva reduces. The progressive nature of the syndrome results in a further reduction of salivary flow. Due to hyposalivation the patients suffer from progressive dental decay, dental erosion, severe dry mouth complaints (i.e. eating and swallowing problems, lack of taste), inflammation of the oral mucosa and lack of retention of removable dentures. Overall, this can be qualified as a reduction in the quality of life. Until now no effective (palliative) therapy to relieve dry mouth complaints is available. A recent case series study suggests that an endoscopic technique (sialoendoscopy) is able to alleviate the symptoms of patients suffering from SS. In this technique the ducts of the salivary glands are rinsed with saline and cortisone and possible strictures are dilated. It is hypothesised that performing a sialoendoscopic treatment will raise or restore (un)stimulated salivary flow levels and improve the reported mouthfeel score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosed (by the European League Against Rheumatism guidelines) primary or secondary Syndrome of Sjögren
- •Age: > 18 years and < 70 years
- •A remaining salivary flow
排除标准
- •A complete lack of measurable salivary flow, also after stimulation of the glands by taste or chewing
- •Acute sialadenitis
- •Use of sialogogue medication (i.e. pilocarpine or cevimeline)
- •Other severe illnesses or physical conditions that make a treatment under general anesthesia impossible or highly riskful.
研究组 & 干预措施
Sialoendoscopy with saline
By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and possible strictures are dilated
干预措施: Sialoendoscopy (Procedure)
Sialoendoscopy with saline
By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and possible strictures are dilated
干预措施: saline (Drug)
Sialoendoscopy: saline and hydrocortisone
By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated
干预措施: Sialoendoscopy (Procedure)
Sialoendoscopy: saline and hydrocortisone
By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated
干预措施: saline (Drug)
Sialoendoscopy: saline and hydrocortisone
By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated
干预措施: hydrocortisone (Drug)
结局指标
主要结局
Change, compared to baseline and to a non-treatment control group, in unstimulated whole mouth saliva in ml/min after sialoendoscopic treatment
时间窗: Baseline, 2 years
To determine the change, compared to baseline and to a non-treatment control group, in the unstimulated whole mouth (UWS) salivary flow after performing sialoendoscopic rinsing (with or without hydrocortisone) and dilatation of strictures of the salivary ducts of the major salivary glands.
次要结局
- Change, compared to baseline and to a non-treatment control group, in the stimulated parotid salivary flow after performing sialoendoscopic rinsing (with or without hydrocortisone)(Baseline, 2 years)
- Change in mouthfeel score (XI score)(Baseline, 2 years)
- Change in the CODS score(Baseline, 2 years)
- Change in the EULAR SS Patient Reported Index score(Baseline, 2 years)
研究者
Derk Jan Jager
DMD PhD
Amsterdam UMC, location VUmc
