Advanced Endoscopic Imaging Using HD+ Endoscopy and i-Scan for Assessment of Mucosal Healing in IBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Crohn´s Disease
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Enrollment
- 232
- Locations
- 1
- Primary Endpoint
- Mucosal healing
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
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
- Therapeutic effect(up to three years)
- Histologic correlation(up to three years)