Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Inflammatory Bowel Disease (IBD)

August 10, 2011 updated by: University of Erlangen-Nürnberg Medical School

Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Patients With Inflammatory Bowel Disease

Precise activity assessment of inflammatory bowel disease (IBD) is essential to determine the extent and severity of the disease for further specific therapy. Nevertheless, despite ongoing developments in the field of gastrointestinal endoscopy, the final diagnosis still relies on the interpretation of histopathological features of intestinal biopsies taken during the endoscopic examination. Recently, endocytoscopy (EC) was introduced as a new endoscopic imaging modality, enabling microscopic imaging within the mucosal layer of the gut at a magnification level of up to 1400-fold.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • University of Erlangen-Nuremberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Crohn's disease and ulcerative colitis who underwent colonoscopy.

Description

Inclusion Criteria:

  • Written informed consent
  • Age 18-85 years
  • Ability of subjects to understand character and individual consequences of clinical trial
  • Subjects undergoing colonoscopy
  • Patients with known Crohn´s disease or ulcerative colitis

Exclusion Criteria:

  • Inability to provide written informed consent
  • Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
  • Impaired renal function (Creatinine > 1.2 mg/dl)
  • Pregnancy or breast feeding
  • Active gastrointestinal bleeding
  • Known allergy to methylene blue or toluidine blue
  • Residing in institutions (e.g. prison)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with IBD
Device: Endocytoscopy
Patients with Crohn's disease and ulcerative colitis who underwent colonoscopy are prospectively included in this study. Methylene blue or toluidine blue is topically applied to enable EC (XEC-120-U, Olympus, Tokyo, Japan). Data are digitally saved and analyzed independently from each other by two gastroenterologists and one pathologist who are blinded to clinical and endoscopic data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the potential of endocytoscopy for in vivo detection of mucosal inflammatory cells.
Time Frame: 40 patients
40 patients

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the potential of endocytoscopy for the determination of intestinal inflammatory activity in patients with quiescent IBD and to compare endocytoscopy results with the results of standard histopathology
Time Frame: 40 patients
40 patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

February 2, 2011

First Submitted That Met QC Criteria

February 2, 2011

First Posted (ESTIMATE)

February 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 10, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN-0006
  • Ecy1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis

Clinical Trials on Endocytoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe