跳至主要内容
临床试验/NCT03878563
NCT03878563终止不适用

Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial

Dr.med. Monica Rusticeanu2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年11月20日最近更新:
适应症

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

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

发起方
Dr.med. Monica Rusticeanu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr.med. Monica Rusticeanu

Dr.med. M. Rusticeanu LÄ stv. Gastroenterologie und Hepatologie

Spital Limmattal Schlieren

研究点 (2)

Loading locations...

相似试验

Alterations in Intestinal Mucosal Barrier Visualized... | 临床试验