Endoscopy for Assessment of Mucosal Healing in IBD

Study Overview
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Brief Summary
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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.

Official Title
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Advanced Endoscopic Imaging Using HD+ Endoscopy and i-Scan for Assessment of Mucosal Healing in IBD

Conditions
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Crohn´s Disease, Ulcerative Colitis

Intervention / Treatment
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* Device: High-definition white light endoscopy and i-Scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn´s disease - active<br>Patients in the active phase of the disease | Device: High-definition white light endoscopy and i-Scan<br>* Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.<br>|
| Crohn´s disease - quiescent<br>Patients in the quiescent phase of the disease | Device: High-definition white light endoscopy and i-Scan<br>* Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.<br>|
| Ulcerative colitis - active<br>Patients in the active phase of the disease | Device: High-definition white light endoscopy and i-Scan<br>* Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.<br>|
| Ucerative colitis - quiescent<br>Patients in the quiescent phase of the disease | Device: High-definition white light endoscopy and i-Scan<br>* Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal healing | 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. | up to three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic correlation | Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse. | up to three years | 
| Therapeutic effect | We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics (e.g. erosions, ulcers, erythema) of mucosal healing. | up to three years |