Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

Not Applicable

• Conditions: Sjögren's Syndrome
• Interventions: Procedure: Sialoendoscopy; Drug: saline; Drug: hydrocortisone

• Registration Number: NCT02112019
• Lead Sponsor: Derk Jan Jager

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-11
• Study Start: 2014-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-11
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sialoendoscopy: saline and hydrocortisone	saline	By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated
Sialoendoscopy with saline	saline	By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and possible strictures are dilated
Sialoendoscopy with saline	Sialoendoscopy	By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and possible strictures are dilated
Sialoendoscopy: saline and hydrocortisone	Sialoendoscopy	By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated
Sialoendoscopy: saline and hydrocortisone	hydrocortisone	By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated

Primary Outcome Measures

Name	Time	Method
Change, compared to baseline and to a non-treatment control group, in unstimulated whole mouth saliva in ml/min after sialoendoscopic treatment	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.

Secondary Outcome Measures

Name	Time	Method
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, 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.
Change in mouthfeel score (XI score)	Baseline, 2 years	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
Change in the CODS score	Baseline, 2 years	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
Change in the EULAR SS Patient Reported Index score	Baseline, 2 years	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

Trial Locations

Locations (1)

VU Medical Center department of Maxillofacial surgery; 🇳🇱 Amsterdam, Netherlands