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临床试验/NCT02112019
NCT02112019Unknown不适用

Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot Study

Derk Jan Jager1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

发起方
Derk Jan Jager
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Derk Jan Jager

DMD PhD

Amsterdam UMC, location VUmc

研究点 (1)

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