Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

Sponsor

Derk Jan Jager (Other)

Overall Status

Unknown status

CT.gov ID

NCT02112019

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sjögren's Syndrome	Procedure: Sialoendoscopy Drug: saline Drug: hydrocortisone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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	Procedure: Sialoendoscopy Drug: saline
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	Procedure: Sialoendoscopy Drug: saline Drug: hydrocortisone
No Intervention: Control: no treatment

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

Procedure: Sialoendoscopy

Drug: saline

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

Procedure: Sialoendoscopy

Drug: saline

Drug: hydrocortisone

No Intervention: Control: no treatment

Outcome Measures

Primary Outcome Measures

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

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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.