Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

Sjögren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02112019
• Other study ID #: NL44018.029.13
• Status: Active, not recruiting
• Phase: N/A
• First received: April 8, 2014
• Last updated: May 9, 2017
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome

Intervention

Procedure:
• Sialoendoscopy

Drug:
• saline

• hydrocortisone

Locations

Country	Name	City	State
Netherlands	VU Medical Center department of Maxillofacial surgery	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Derk Jan Jager

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change, compared to baseline and to a non-treatment control group, in unstimulated whole mouth saliva in ml/min after sialoendoscopic treatment	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.	Baseline, 2 years
Secondary	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)	Change, compared to baseline and to a non-treatment control group, in the stimulated parotid (SP) salivary flow after performing sialoendoscopic rinsing (with or without hydrocortisone) and dilatation of strictures of the salivary ducts of the major salivary glands.	Baseline, 2 years
Secondary	Change in mouthfeel score (XI score)	Change in mouthfeel score (XI score) after sialoendoscopic treatment, with or without rinsing with hydrocortisone, compared to baseline and compared to a non-treatment control group	Baseline, 2 years
Secondary	Change in the EULAR SS Patient Reported Index score	Change in the ESSPRI (EULAR SS Patient Reported Index) score after sialoendoscopic treatment, with or without rinsing with hydrocortisone, compared to baseline and compared to a non-treatment control group	Baseline, 2 years
Secondary	Change in the CODS score	Change in the CODS score after sialoendoscopic treatment, with or without rinsing with hydrocortisone, compared to baseline and compared to a non-treatment control group	Baseline, 2 years