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

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ClinicalTrials.gov Identifier: NCT03658551
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz

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
Cirrhosis, Liver 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.


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Study Type : Observational
Estimated Enrollment : 100 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 : August 1, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis Endoscopy

Group/Cohort 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 Name: 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 Name: Intravenous application of fluorescein




Primary Outcome Measures :
  1. Amount of intestinal permeability [ Time Frame: August 2020 ]
    Intensity of fluorescein concentration in the gastrointestinal mucosa


Biospecimen Retention:   Samples With DNA
Tissue biopsy, serum, EDTA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with liver cirrhosis
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658551


Contacts
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Contact: Jörn M. Schattenbrg, MD 00496131176074 joern.schattenberg@unimedizin-mainz.de
Contact: Michael Nagel, MD michael.nagel@unimedizin-mainz.de

Locations
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Germany
University Medical Center of the Johannes Gutenber Univeristy Recruiting
Mainz, Germany, 55131
Contact: Michael Nagel, MD       michael.nagel@unimedizin-mainz.de   
Principal Investigator: Jörn M Schattenberg, MD         
Principal Investigator: Helmut Neumann, MD         
University Medical Center of the Johannes Gutenber Univeristy Recruiting
Mainz, Germany, 55131
Principal Investigator: Jörn M Schattenberg, MD         
Sponsors and Collaborators
Johannes Gutenberg University Mainz

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Responsible Party: Priv.-Doz. Dr. J. Schattenberg, Principal Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT03658551     History of Changes
Other Study ID Numbers: CEDIP_LCI_JGU
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz:
Portal hypertension
Intestinal permeability
Liver cirrhosis
bacterial translocation
confocal endoscopy

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics