Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome
Primary Purpose
Sjögren's Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Sialoendoscopy
saline
hydrocortisone
Sponsored by
About this trial
This is an interventional supportive care trial for Sjögren's Syndrome focused on measuring Sjögren's Syndrome, Sialoendoscopy, Saliva, Dry Mouth
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.
Sites / Locations
- VU Medical Center department of Maxillofacial surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Sialoendoscopy with saline
Sialoendoscopy: saline and hydrocortisone
Control: no treatment
Arm Description
By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and possible strictures are dilated
By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated
Outcomes
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
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)
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)
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02112019
Brief Title
Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome
Official Title
Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Derk Jan Jager
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjögren's Syndrome
Keywords
Sjögren's Syndrome, Sialoendoscopy, Saliva, Dry Mouth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sialoendoscopy with saline
Arm Type
Experimental
Arm Description
By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and possible strictures are dilated
Arm Title
Sialoendoscopy: saline and hydrocortisone
Arm Type
Active Comparator
Arm Description
By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated
Arm Title
Control: no treatment
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Sialoendoscopy
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Type
Drug
Intervention Name(s)
hydrocortisone
Primary Outcome Measure Information:
Title
Change, compared to baseline and to a non-treatment control group, in unstimulated whole mouth saliva in ml/min after sialoendoscopic treatment
Description
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.
Time Frame
Baseline, 2 years
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline, 2 years
Title
Change in mouthfeel score (XI score)
Description
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
Time Frame
Baseline, 2 years
Title
Change in the EULAR SS Patient Reported Index score
Description
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
Time Frame
Baseline, 2 years
Title
Change in the CODS score
Description
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
Time Frame
Baseline, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
VU Medical Center department of Maxillofacial surgery
City
Amsterdam
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome
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