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

Liver Cirrhoses Clinical Trial

— AMBIC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03878563
• Other study ID #: 2017-00249
• Status: Terminated
• Start date: November 20, 2017
• Est. completion date: June 20, 2019

Study information

• Verified date: July 2020
• Source: Spital Limmattal Schlieren
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhoses
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Universitätsspital Bern	Bern
Switzerland	Limmattal Spital	Schlieren	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
Dr.med. Monica Rusticeanu	University Hospital Inselspital, Berne, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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