Endoscopy for Assessment of Mucosal Healing in IBD

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. i-Scan use an endoscopic image from the video processor and reconstruct virtual images in real time, resulting in an improved contrast of the capillary patterns and enhancement of the mucosal surface (so called virtual chromoendoscopy).

The main objective of this study is to determine endoscopic features of mucosal healing in patients with IBD and to compare these features to clinical and histological data in order to establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing as a parameter of remission and relapse.

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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)
Proctocolectomy

Treatment and study plan

High-definition white light endoscopy and i-Scan

Device

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

Primary outcomes

Mucosal healing

Time frame: up to three years

We will determine high-definition white light endoscopic and i-Scan features of mucosal inflammation (e.g. erosions, erythema, ulcerous lesions) 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.
Therapeutic effect

Time frame: up to three years

We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics (e.g. erosions, ulcers, erythema) of mucosal healing.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Advanced Endoscopic Imaging Using HD+ Endoscopy and i-Scan 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