Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

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

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.

Study Overview

• Status: Unknown
• Conditions: Sjögren's Syndrome
• Intervention / Treatment: Drug: saline; Procedure: Sialoendoscopy; Drug: hydrocortisone

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • VU Medical Center department of Maxillofacial surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Derk Jan Jager

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Saliva; Sjögren's Syndrome; Sialoendoscopy; Dry Mouth
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: NL44018.029.13