Endomicroscopy and Crohn´s Disease

Confocal Laser Endomicroscopy in Patients With Crohn´s Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01102855

Enrollment

Registered

2010-04-13

Start date

2009-10-31

Completion date

2011-08-31

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn´s Disease

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Comparison of CLE findings with conventional histology.	October 2009 until May 2010

Countries

Germany

Outcome results