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

Terminated

• Conditions: Liver Cirrhoses
• Interventions: Device: Cellvisio 100 Series (fibered confocal microscopic system)

• Registration Number: NCT03878563
• Lead Sponsor: Dr.med. Monica Rusticeanu

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-20
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ascites and normal protein concentration	Cellvisio 100 Series (fibered confocal microscopic system)	Liver cirrhosis witha scites and protein concentration \>1,5 g/d
ascites and decreased protein concentrati	Cellvisio 100 Series (fibered confocal microscopic system)	Cirrhosis with ascites and decreased protein concentration \<1,5 g/d
ascites with/without SBP	Cellvisio 100 Series (fibered confocal microscopic system)	Cirrhosis with ascites and existing SBP or prior SBP
Healthy controls without liver cirrhosis or other pathology	Cellvisio 100 Series (fibered confocal microscopic system)	Healthy pacients (without chronic disease) undergoing screening coloscopy or gastroscopy
Liver cirrhosis without ascites	Cellvisio 100 Series (fibered confocal microscopic system)	Patients with liver corrhosis without ascites

Primary Outcome Measures

Name	Time	Method
occurrence of spontaneous bacterial peritonitis at 12 months	24 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.

Trial Locations

Locations (2)

Limmattal Spital; 🇨🇭 Schlieren, Zürich, Switzerland

Universitätsspital Bern; 🇨🇭 Bern, Switzerland