Endomicroscopy and Crohn´s Disease

Completed

• Conditions: Crohn´s Disease

• Registration Number: NCT01102855
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

Purpose:

The main objective of this study is to determine endomicroscopic features of Crohn´s disease.

Background:

Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.

Scope:

In patients with Crohn´s disease.

Detailed Description

Methods:

Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed.

Procedure:

The patient underwent colonoscopy. During the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Written informed consent
• Age 18-85 years
• Ability of subjects to understand character and individual consequences of clinical trial
• Subjects undergoing colonoscopy

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 fluorescein, acriflavin or cresyl violet
• Residing in institutions (e.g. prison)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine endomicroscopic features of Crohn´s disease.	October 2009 until May 2010

Secondary Outcome Measures

Name	Time	Method
Comparison of CLE findings with conventional histology.	October 2009 until May 2010

Trial Locations

Locations (1)

Department of Medicine I, University of Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany