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

Study Overview
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Brief Summary
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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)

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

Conditions
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Liver Cirrhoses

Intervention / Treatment
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* Device: Cellvisio 100 Series (fibered confocal microscopic system)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ascites with/without SBP<br>Cirrhosis with ascites and existing SBP or prior SBP | Device: Cellvisio 100 Series (fibered confocal microscopic system)<br>* 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.<br>|
| ascites and decreased protein concentrati<br>Cirrhosis with ascites and decreased protein concentration <1,5 g/d | Device: Cellvisio 100 Series (fibered confocal microscopic system)<br>* 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.<br>|
| ascites and normal protein concentration<br>Liver cirrhosis witha scites and protein concentration >1,5 g/d | Device: Cellvisio 100 Series (fibered confocal microscopic system)<br>* 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.<br>|
| Liver cirrhosis without ascites<br>Patients with liver corrhosis without ascites | Device: Cellvisio 100 Series (fibered confocal microscopic system)<br>* 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.<br>|
| Healthy controls without liver cirrhosis or other pathology<br>Healthy pacients (without chronic disease) undergoing screening coloscopy or gastroscopy | Device: Cellvisio 100 Series (fibered confocal microscopic system)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal barrier dysfunction