NCT03658551

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

September 1, 2018

Last Update Submit

March 28, 2022

Conditions

Cirrhosis, Liver

Keywords

Portal hypertensionIntestinal permeabilityLiver cirrhosisbacterial translocationconfocal endoscopy

Outcome Measures

Primary Outcomes (1)

  • Amount of intestinal permeability

    Intensity of fluorescein concentration in the gastrointestinal mucosa

    August 2020

Study Arms (2)

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

Control group

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

Diagnostic Test: Fluorescein

Interventions

FluoresceinDIAGNOSTIC_TEST

Measurement of intensity in the gastrointestinal mucosa after intravenous administration of fluorescein by confocal endoscopy

Also known as: Intravenous application of fluorescein
Control groupLiver cirrhosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with liver cirrhosis

You may qualify if:

  • liver cirrhosis
  • need of upper endoscopy
  • signed consent
  • abdominal symptoms with indication for endoscopy

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center of the Johannes Gutenber Univeristy

Mainz, 55131, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue biopsy, serum, EDTA

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Interventions

Fluorescein Angiography

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AngiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Ophthalmological

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2018

First Posted

September 5, 2018

Study Start

August 1, 2017

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

DE(1)