Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

Study Overview
=================
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.

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

Conditions
-----------------
Sjögren's Syndrome

Intervention / Treatment
-----------------
* Procedure: Sialoendoscopy
* Drug: saline
* Drug: hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sialoendoscopy with saline<br>By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and possible strictures are dilated | Procedure: Sialoendoscopy<br> <br> Drug: saline<br> <br> |
| Active Comparator: Sialoendoscopy: saline and hydrocortisone<br>By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated | Procedure: Sialoendoscopy<br> <br> Drug: saline<br> <br> Drug: hydrocortisone<br> <br> |
| No Intervention: Control: no treatment<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sjögren's Syndrome, Sialoendoscopy, Saliva, Dry Mouth