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

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

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 Overview

• Status: Terminated
• Conditions: Liver Cirrhoses
• Intervention / Treatment: Device: Cellvisio 100 Series (fibered confocal microscopic system)

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Universitätsspital Bern
  • Zürich
    • Schlieren, Zürich, Switzerland, 8952
      • Limmattal Spital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with liver cirrhosis and healthy controls, older than 18 years and younger than 80 years

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ascites with/without SBP; Cirrhosis with ascites and existing SBP or prior SBP	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.
ascites and decreased protein concentrati; Cirrhosis with ascites and decreased protein concentration <1,5 g/d	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.
ascites and normal protein concentration; Liver cirrhosis witha scites and protein concentration >1,5 g/d	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.
Liver cirrhosis without ascites; Patients with liver corrhosis without ascites	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.
Healthy controls without liver cirrhosis or other pathology; Healthy pacients (without chronic disease) undergoing screening coloscopy or gastroscopy	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr.med. Monica Rusticeanu
• Collaborators: University Hospital Inselspital, Berne; University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: intestinal barrier dysfunction
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 2017-00249

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No