Clinical trial NCT02112019: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sjögren's Syndrome
Keywords: Sjögren's Syndrome
Sialoendoscopy
Saliva
Dry Mouth
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change, compared to baseline and to a non-treatment control group, in unstimulated whole mouth saliva in ml/min after sialoendoscopic treatment
timeFrame: Baseline, 2 years
Secondary outcomes:
measure: 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)
timeFrame: Baseline, 2 years
measure: Change in mouthfeel score (XI score)
timeFrame: Baseline, 2 years
measure: Change in the EULAR SS Patient Reported Index score
timeFrame: Baseline, 2 years
measure: Change in the CODS score
timeFrame: Baseline, 2 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Center department of Maxillofacial surgery
Study officials:
References: