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

Dr.med. Monica Rusticeanu26 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Cirrhoses

Interventions

This system is intended to allow confocal laser imaging of the internal microstructure of tissues within or adjacent to anatomical tracts, i.e. Gastrointestinal accessed trough an endoscope. An 488-nm wavelength laser system is used, images are steamed at a frame rate of 12 frames per second, obtaining real time videos of the mucosa. In this trial we will use the Confocal miniprobe ColoFlex UHD and GastroFlex UHD.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Adult individual (\>18yo) with liver cirrhosis of any cause and healthy controls undergoing elective endoscopy Exclusion Criteria: * 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

Outcomes

Primary Outcomes

occurrence of spontaneous bacterial peritonitis at 12 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.

Time frame: 24 months