Sjögren's syndrome
Conditions
Interventions
CEUSS is a classic endoscopic technique combined with US imaging, specially designed for application in large salivary glands. In every patient, under local anaesthesia, a US-guided infusion of microb
Septodont, Saint-Maru-des-Fosses, France) is injected submucosally near the papilla. Next, the endoscope is properly positioned in the salivary duct (Figure 1) under echoscopic guidance. Sialendoscopy
Sponsors
Amsterdam UMC, VU Medical Center dep. of Oral and Maxillofacial Surgery and Oral Pathology
Eligibility
Inclusion criteria
Inclusion criteria: - A diagnosed (by the 2016 ACR-EULAR criteria) primary or secondary Sjögren’s syndrome - Age: =18 years and = 75 years - A remaining salivary flow: UWS=0.02, SWS=0.10 ml/min
Exclusion criteria
Exclusion criteria: - A remaining salivary flow: UWS90 mmHg) or uncontrolled hypertension, adult respiratory distress syndrome or severe cardiac dysrhythmias. - Use of Dobutamine. Sonovue should not be used in combination with dobutamine (used for heart failure) in patients with conditions that suggest cardiovascular instability where dobutamine is contraindicated. - Presence of MALT-lymphoma in the major salivary glands
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main outcomes will be an evaluation of the safety and practical applicability of the experimental treatment. Safety will be determined by unanticipated treatment-related mortality, and the occurrence of adverse events (AEs) and serious adverse events (SAEs). AEs will be defined as any undesirable experience occurring to a subject during the experimental treatment period, whether or not related to the investigational intervention. SAEs will be defined as any untoward medical occurrence or effect that, at any dose is life threatening (at the time of the event); requires hospitalization or prolongation of existing in-patients’ hospitalization; results in persistent or significant disability or incapacity; or is a new event of the trial likely to affect the safety of the subjects, such as an unexpected outcome of an adverse reaction. Practical applicability will be defined as accomplishment of the experimental protocol during the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory outcomes of CEUSS will include measurements of unstimulated whole mouth saliva flow (UWSF), stimulated whole mouth saliva flow (SWSF), stimulated parotid saliva flow (SPSF) and the clinical oral dryness score (CODS) [21,22]. Changes due to CEUSS in reported pain, mouthfeel and clinical SS symptoms will be determined in comparison to initial values using a set of validated questionnaires, i.e., the McGill Pain Questionnaire (MPQ), Xerostomia Inventory (XI), and European League Against Rheumatism (EULAR) Sjögren’s Syndrome Patient Reported Index (ESSPRI). Furthermore, changes in salivary cytokine profiles will be determined (IL-1ß, IL-6, BAFF, IL-12, IL-18 and TNFa). Finally, salivary gland topographical alterations will be evaluated by US using the Hocevar score. The echostructure of the treated glands will be graded at T-4 (4 weeks before intervention), T1 (1 week after intervention) and T16 (16 weeks after intervention). | — |
Contacts
Public ContactDerk Hendrik Jan Jager
Amsterdam UMC, VU Medical Center
Outcome results
None listed