Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- occurrence of spontaneous bacterial peritonitis at 12 months
研究概览
简要总结
Clinical trial with medical devices. A diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(SBP), which is a complication of liver cirrhosis with ascites.The current recommendation for primary prophylaxis of SBP include a low protein content of the ascitic fluid or a gastrointestinal bleeding. This trial will use the CLE (confocal laser endomicroscopy) technic in order to quantify the intestinal permeability in patients with liver cirrhosis and correlate this to the onset of spontaneous bacterial peritonitis.We aim to evaluate a new diagnostic tool (the confocal laser endoscopy(CLE) technique -cellvizio- in the setting of endoscopy and defining parameters that are altered in cirrhotic patients of different severity and being at risk of developing a SBP (spontaneous bacterial peritonitis).The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for time to occurrence of spontaneous bacterial peritonitis.
Defining a correlation between the quantified loss of intestinal integrity and i) total protein concentration in the ascitic fluid and ii) stadium of liver disease (Child class A, B or C)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult individual (>18yo) with liver cirrhosis of any cause and healthy controls undergoing elective endoscopy
排除标准
- •Patients younger than < 18, older than 80 years
- •Pregnant or breastfeeding women
- •Known allergy to fluorescein.
- •Cardiac disease
- •Asthma bronchiale
- •Patients with inability or unwillingness to provide blood samples or samples of ascitic fluid.
- •patients unable to give informed consent
- •non-resident patients
- •contraindication for an endoscopic examination
结局指标
主要结局
occurrence of spontaneous bacterial peritonitis at 12 months
时间窗: 24 months
The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for occurrence of spontaneous bacterial peritonitis for the next 12 months.
次要结局
未报告次要终点
研究者
Dr.med. Monica Rusticeanu
Dr.med. M. Rusticeanu LÄ stv. Gastroenterologie und Hepatologie
Spital Limmattal Schlieren
