Intra-operative visualization and treatment of salivary glands affected by sjögren*s syndrome using contrast enhanced ultrasound sialendoscopy (ceuss): a pilot study
- Conditions
- HyposalivationSjogren's Syndrome1000381610014705
- Registration Number
- NL-OMON49417
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
- A diagnosed (by the 2002 ACR-EULAR criteria) primary or secondary Sjögren*s
Syndrome
- Age: *18 years and * 80 years
- A remaining salivary flow: UWS*0.02, SWS*0.10 ml/min
- A remaining salivary flow: UWS<0.02, SWS<0.10 ml/min
- When it is not possible to identify and enter the orifice of the salivary
duct(s) (determined during T-6)
- Acute sialadenitis, severe illness or physical conditions interfering with
the intervention
- Use of sialogogue medication (i.e. Pilocarpine)
- A history of head and neck radiotherapy
- Cardiac patients with an (suspected) acute coronary syndrome, recent
percutaneous coronary intervention, acute or chronic severe [New York Heart
Association (NYHA) class III/IV] heart failure, right-to-left shunts, severe
pulmonary hypertension (pulmonary artery pressure >90*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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main endpoints will be technical feasibility and safety of the experimental<br /><br>treatment. Technical feasibility will be defined as accomplishment of the<br /><br>experimental protocol during the procedure. </p><br>
- Secondary Outcome Measures
Name Time Method