Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

NCT02112019 | Unknown DMC

• 1 other identifier: NL44018.029.13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjögren's Syndrome

Keywords

Sjögren's Syndrome; Sialoendoscopy; Saliva; Dry Mouth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 in mouthfeel score (XI score)

  Baseline, 2 years

• Change in the EULAR SS Patient Reported Index score

  Baseline, 2 years

• Change in the CODS score

  Baseline, 2 years

Study Arms (3)

Sialoendoscopy with saline

EXPERIMENTAL

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

Procedure: Sialoendoscopy; Drug: saline

Sialoendoscopy: saline and hydrocortisone

ACTIVE COMPARATOR

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

Control: no treatment

NO INTERVENTION

Interventions

Sialoendoscopy PROCEDURE

Sialoendoscopy with saline; Sialoendoscopy: saline and hydrocortisone

saline DRUG

Sialoendoscopy with saline; Sialoendoscopy: saline and hydrocortisone

hydrocortisone DRUG

Sialoendoscopy: saline and hydrocortisone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derk Jan Jager: lead

Study Sites (1)

VU Medical Center department of Maxillofacial surgery

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia

Interventions

Sodium Chloride; Hydrocortisone

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DMD PhD

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 11, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

NL (1)