CEDIP-LCI: Intestinal Permeability in Patients With Liver Cirrhosis Using Confocal Endoscopy

Sponsor
Johannes Gutenberg University Mainz (Other)
Overall Status
Terminated
CT.gov ID
NCT03658551
Collaborator
(none)
15
1
36
0.4

Study Details

Study Description

Brief Summary

The CEDIP LCI study is intended to show the difference in intestinal permeability between compensated and decompensated liver cirrhosis by confocal endoscopy.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Fluorescein

Detailed Description

Liver cirrhosis often represents the end of many different liver diseases. A progress of liver cirrhosis with development of bleeding and infection complications represents a significant burden on the health system. It is therefore more important that the molecular basis leading to progress of liver cirrhosis is studied. In the last few years it has been demonstrated in various animal models as well as in human studies that the liver via the portal vein circuit is constantly under the influence of macronutrients, toxins, microbial products and microorganisms from the gastrointestinal tract. Patients with hepatic cirrhosis suffer from increased intestinal permeability so that bacterial components, endotoxins and pathogens enter the portal vein circuit via mesenteric lymph nodes. Bacterial translocations were found in patients with advanced liver cirrhosis and restricted organ function. This translocation causes a local as well as systemic inflammation with an increase in portal hypertension and further deterioration of the hepatic function, as well as a hyperdynamic circulatory situation which in many cases can lead to the death of the patient. These findings on the pathogenesis of portal hypertension and complications of cirrhosis of the liver have already led to the first therapeutic approaches where the occurrence of hepatic encephalopathy could be reduced by a purely intestinal reduction of the bacterial load by the antibiotic rifaxamine.

The intestinal barrier describes a functional and physical unit that ensures regulated intraluminal transport and protects against microorganisms and other pathogenic molecules. In addition to the intestinal epithelium with superposed mucus, intercellular proteins constitute an essential component. These paracellular proteins include tight junctions, anchoring junctions and GAP junctions, which are also responsible for controlled paracellular transport.

The cause of increased intestinal permeability in patients with liver cirrhosis are manifold. In addition to altered microbial colonization and slowed intestinal transit time, structural changes in the intestinal wall and altered expression of the tight junctions.

Due to the increasing insight into the molecular pathogenesis of intestinal permeability including portal hypertension, it is necessary to quantify these parameters more precisely in the clinical routine and to develop possible therapeutic interventions therefrom. An endoscopic procedure is provided by confocal endoscopy, with the aid of which portal hypertension and intestinal permeability can be diagnosed and estimated. With the help of this clinical study, this procedure is to be established.

Study Design

Study Type:
Observational
Actual Enrollment :
15 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Confocal Endoscopy to Diagnose the Intestinal Permeability in Patients With Compensated and Decompensated Liver Cirrhosis
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Liver cirrhosis

Patients with liver cirrhosis are included in this arm. Liver cirrhosis is diagnosed by ultrasound, CT - scan oder by clinical signs.

Diagnostic Test: Fluorescein
Measurement of intensity in the gastrointestinal mucosa after intravenous administration of fluorescein by confocal endoscopy
Other Names:
  • Intravenous application of fluorescein
  • Control group

    Patients with abdominal symptoms with the indication for endoscopy without liver cirrhosis and portal Hypertension.

    Diagnostic Test: Fluorescein
    Measurement of intensity in the gastrointestinal mucosa after intravenous administration of fluorescein by confocal endoscopy
    Other Names:
  • Intravenous application of fluorescein
  • Outcome Measures

    Primary Outcome Measures

    1. Amount of intestinal permeability [August 2020]

      Intensity of fluorescein concentration in the gastrointestinal mucosa

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • liver cirrhosis

    • need of upper endoscopy

    • signed consent

    • abdominal symptoms with indication for endoscopy

    Exclusion Criteria:
    • pregnancy

    • Lactation

    • Hypersensitivity to fluorescein

    • Limited coagulation situation (Quick <50%, PTT> 50 sec, thrombocyte count <50000 / μl or disturbed thrombocyte function) despite the substitution of coagulation factors / plasma products

    • Limited or non-existent consent

    • Restricted or inadequate ability to perform endoscopy and / or confocal imaging: restlessness of the patient, food residues, anatomical variants that make confocal imaging difficult (e.g., strictures)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center of the Johannes Gutenber Univeristy Mainz Germany 55131

    Sponsors and Collaborators

    • Johannes Gutenberg University Mainz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jörn M. Schattenberg, Principal Investigator, Johannes Gutenberg University Mainz
    ClinicalTrials.gov Identifier:
    NCT03658551
    Other Study ID Numbers:
    • CEDIP_LCI_JGU
    First Posted:
    Sep 5, 2018
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Jörn M. Schattenberg, Principal Investigator, Johannes Gutenberg University Mainz
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2022