Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

Derk Jan Jager

Status: Unknown

Conditions: Sjögren's Syndrome

Treatments: Procedure: Sialoendoscopy; Drug: saline; Drug: hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT02112019

NL44018.029.13

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

Sialoendoscopy with saline

Experimental group

Description:

By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and possible strictures are dilated

Treatment:

Drug: saline

Procedure: Sialoendoscopy

Sialoendoscopy: saline and hydrocortisone

Active Comparator group

Description:

By performing a sialoendoscopy, the ducts of the salivary glands are rinsed with saline and hydrocortisone and possible strictures are dilated

Treatment:

Drug: saline

Drug: hydrocortisone

Procedure: Sialoendoscopy

Control: no treatment

No Intervention group