Crohn´s Disease, Ulcerative Colitis
Conditions
Brief summary
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.
Interventions
DEVICEHigh-definition white light endoscopy and i-Scan
Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal healing | 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
| Measure | Time frame | Description |
|---|---|---|
| Histologic correlation | 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 | 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. |
Countries
Germany
Outcome results
None listed