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

NCT ID: NCT03878563

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-20
• Study Completion Date: 2019-06-20

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

ascites with/without SBP

Cirrhosis with ascites and existing SBP or prior SBP

Cellvisio 100 Series (fibered confocal microscopic system)

Intervention Type: 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.

ascites and decreased protein concentrati

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

Cellvisio 100 Series (fibered confocal microscopic system)

Intervention Type: 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.

ascites and normal protein concentration

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

Cellvisio 100 Series (fibered confocal microscopic system)

Intervention Type: 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.

Liver cirrhosis without ascites

Patients with liver corrhosis without ascites

Cellvisio 100 Series (fibered confocal microscopic system)

Intervention Type: 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

Healthy pacients (without chronic disease) undergoing screening coloscopy or gastroscopy

Cellvisio 100 Series (fibered confocal microscopic system)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: collaborator

Dr.med. Monica Rusticeanu

OTHER

Sponsor Role: lead

Responsible Party

Dr.med. Monica Rusticeanu

Dr.med. M. Rusticeanu LÄ stv. Gastroenterologie und Hepatologie

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Limmattal Spital

Schlieren, Canton of Zurich, Switzerland

Universitätsspital Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2017-00249

Identifier Type: -

Identifier Source: org_study_id