Endomicroscopy and Crohn´s Disease

Crohn´s Disease Clinical Trial

Official title:

Confocal Laser Endomicroscopy in Patients With Crohn´s Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102855
• Other study ID #: HN-0002
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: August 10, 2011
• Start date: October 2009
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn´s Disease

Locations

Country	Name	City	State
Germany	Department of Medicine I, University of Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine endomicroscopic features of Crohn´s disease.		October 2009 until May 2010	Yes
Secondary	Comparison of CLE findings with conventional histology.		October 2009 until May 2010	Yes