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

NCT03878563 | Terminated

• 1 other identifier: 2017-00249
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

intestinal barrier dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

ascites with/without SBP

Cirrhosis with ascites and existing SBP or prior SBP

Device: Cellvisio 100 Series (fibered confocal microscopic system)

ascites and decreased protein concentrati

Cirrhosis with ascites and decreased protein concentration \<1,5 g/d

Device: Cellvisio 100 Series (fibered confocal microscopic system)

ascites and normal protein concentration

Liver cirrhosis witha scites and protein concentration \>1,5 g/d

Device: Cellvisio 100 Series (fibered confocal microscopic system)

Liver cirrhosis without ascites

Patients with liver corrhosis without ascites

Device: Cellvisio 100 Series (fibered confocal microscopic system)

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)

Interventions

Cellvisio 100 Series (fibered confocal microscopic system) DEVICE

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; Liver cirrhosis without ascites; ascites and decreased protein concentrati; ascites and normal protein concentration; ascites with/without SBP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult individual (\>18yo) with liver cirrhosis of any cause and healthy controls undergoing elective endoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr.med. Monica Rusticeanu: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• University of Bern: collaborator

Study Sites (2)

Limmattal Spital

Schlieren, Canton of Zurich, 8952, Switzerland

Location

Universitätsspital Bern

Bern, 3010, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.med. M. Rusticeanu LÄ stv. Gastroenterologie und Hepatologie

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: November 20, 2017
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

CH (2)