Endomicroscopy for Assessment of Mucosal Healing

Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns 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.

The main objective of this study is to determine endomicroscopic features of mucosal healing in patients with IBD.

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Key information

Conditions

Crohn´s Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Erlangen-Nuremberg

Erlangen, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
Pregnancy or breast feeding
Active gastrointestinal bleeding
Residing in institutions (e.g. prison)
Known allergy against fluorescein
Proctocolectomy

Treatment and study plan

Endomicroscopy

Device

Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.

Primary outcomes

Mucosal healing

Time frame: up to three years

We will determine endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to establish a new endoscopic classification of mucosal healing.

Secondary outcomes

Histologic correlation

Time frame: up to three years

Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.
Therapeutic effect

Time frame: up to three years

We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage).

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Aug 16, 2011
Registry last updated: Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed