NCT03878563

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Dr.med. Monica Rusticeanu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

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)

Conditions

• Liver Cirrhoses

Interventions

Type	Name	Description
DEVICE	Cellvisio 100 Series (fibered confocal microscopic system)	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.

Timeline

• Start date: 2017-11-20
• Primary completion: 2019-06-20
• Completion: 2019-06-20
• First posted: 2019-03-18
• Last updated: 2020-07-13

Locations

2 sites across 1 country: Switzerland