NL-OMON26628尚未招募不适用
Intra-Operative Visualization and Treatment of Salivary Glands in Sjögren’s Syndrome by Contrast-Enhanced Ultrasound Sialendoscopy (CEUSS): Protocol for a Phase I Single-Center, Single-Arm, Exploratory Study.
Amsterdam UMC, VU Medical Center dep. of Oral and Maxillofacial Surgery and Oral Pathology0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •- 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
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