Trial record 6 of 85 for:    "Sjogren's Syndrome"

Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by VU University Medical Center
Sponsor:
Information provided by (Responsible Party):
Derk Jan Jager, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT02112019
First received: April 8, 2014
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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 Intervention
Sjögren's Syndrome
Procedure: Sialoendoscopy
Drug: saline
Drug: hydrocortisone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

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 [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: June 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112019

Contacts
Contact: Derk-Jan Jager, DMD, PhD d.jager@vumc.nl
Contact: Hakki Karagozoglu, DDS, MD KH.Karagozoglu@vumc.nl

Locations
Netherlands
VU Medical Center department of Maxillofacial surgery Recruiting
Amsterdam, Netherlands
Contact: Derk-Jan Jager, DMD, PhD       d.jager@vumc.nl   
Principal Investigator: Derk Jan Jager, MD, PhD         
Sponsors and Collaborators
Derk Jan Jager
  More Information

No publications provided

Responsible Party: Derk Jan Jager, DMD PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02112019     History of Changes
Other Study ID Numbers: NL44018.029.13
Study First Received: April 8, 2014
Last Updated: June 3, 2014
Health Authority: The Netherlands: Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
Sjögren's Syndrome
Sialoendoscopy
Saliva
Dry Mouth

Additional relevant MeSH terms:
Sjogren's Syndrome
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on July 29, 2014