Study Results
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Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2011-05-31
2013-08-31
Brief Summary
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Detailed Description
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Therefore effective treatment of IBD should imply thoroughly and, if possible, complete healing of bowel ulcerations in parallel with clinical remission. There is evidence that infliximab, an immunoglobulin G1 monoclonal antibody against tumour necrosis factor, not only rapidly improves symptoms in patients with refractory IBDs, but also induces mucosal healing of ileocolonic lesions by week 4 after intravenous administration. The key question of course is whether healing of the mucosa of the bowel improves also the microstructural level of the mucosa and submucosa and perhaps translocation of commensal bacteria and barrier function as well. The validity of healing and maintain microscopic healing of the bowel mucosa and submucosa still has to be shown. Clinical studies showed that infliximab heals the mucosa of the colon in up to 60% by 8 weeks and maintains this healing for al long period of time. Unfortunately treatments that heal the mucosa do not cure Crohn's disease or ulcerative colitis; however, they are associated with a prolongation of the symptom free interval in comparison with the non-healed bowel. This fact suggests that the disease mechanism in the mucosa does not disappear with macroscopic healing of the ulcers and that the intraluminal trigger ends up damaging the mucosa again. For the purpose of clinical trials mucosal healing was defined so far by macroscopic view on the mucosa during white light endoscopy.
A microscopic analysis of the microstructure for assessment of healing seems to be necessary, especially to define objective end points for infliximab therapy to prevent relapses and complications. It is known that mucosal healing does not always correlate with clinical remission, therefore a microscopic diagnosis of ongoing inflammation is necessary.
Recently, a miniaturized confocal microscope was developed which could be integrated in the distal tip of a conventional colonoscope. This new diagnostic technology for gastrointestinal endoscopy, denoted confocal endomicroscopy, allowed in vivo histology of the mucosal layer during ongoing colonoscopy. Furthermore, in patients screened for sporadic colorectal cancer, surface and subsurface analysis at cellular and subcellular resolution could be used to predict intraepithelial neoplasias (INs) with high accuracy. Endomicroscopic image acquisition is performed by placing the tip of the colonoscope in direct contact with the targeted tissue site and providing in this manner surface and subsurface imaging at the time of ongoing video colonoscopy. It allows the detailed analysis of colorectal crypt architecture, deep vascular net structure and detailed mucosal / submucosal analysis. Studies in patients with ulcerative colitis showed that this novel endoscopic approach allowed to diagnose flat intraepithelial neoplasias with a high degree of accuracy and thus emerges as a crucial innovative imaging technology in the colon. Here, we propose to analyze the mucosa of patients with Crohn´s disease and ulcerative colitis before and after infliximab therapy using endomicroscopy for analysing microscopic healing processes during ongoing endoscopy.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy or breast-feeding
* Severe uncontrolled coagulopathy
* Impaired renal function
* Known allergy to fluorescein
18 Years
70 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Locations
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Department of Medicine I, University of Erlangen-Nuremberg
Erlangen, , Germany
Countries
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References
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Hundorfean G, Chiriac MT, Mihai S, Hartmann A, Mudter J, Neurath MF. Development and Validation of a Confocal Laser Endomicroscopy-Based Score for In Vivo Assessment of Mucosal Healing in Ulcerative Colitis Patients. Inflamm Bowel Dis. 2017 Dec 19;24(1):35-44. doi: 10.1093/ibd/izx012.
Other Identifiers
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Mudter2011
Identifier Type: -
Identifier Source: org_study_id