Ulcerative Colitis Clinical Trial
— I-Scan-CLE-IBDOfficial title:
The Value of Virtual Chromoendoscopy With i-SCAN and Confocal Laser Endomicroscopy in the Assessement of Dysplasia on Patients With Inflammatory Bowel Disease
Verified date | January 2018 |
Source | University of Medicine and Pharmacy Craiova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing endoscopy. The potential role of CLE has been explored in pathology of both upper and lower gastrointestinal tract, showing good accuracy for predicting the final histopathological diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its minute scanning area, this techology is best used in conjunction with other "red-flag" techniques to screen the mucosa for areas of interest, which can then be examined by CLE for a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have been no studies to determine the role of this technology in the evaluation of activity in inflammatory bowel disease. The study protocol is based on comparing imaging findings of p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of inflammatory bowel disease. CLE might have an important role in IBD patients management, by assessing the inflammation, dysplasia or response to treatment.
Status | Terminated |
Enrollment | 15 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age > 18 years old, male or female - Patients diagnosed with active ulcerative colitis (MAYO score >3) or Crohn's disease (CDAI score >150), where an indication for treatment and colonoscopy exists. Newly diagnosed as well as patients already on oral 5-ASA therapy, may be included. - Signed informed consent for colonoscopy and p-CLE examination Exclusion Criteria: - Failure to provide informed consent - Patients with a contraindication to colonoscopy - Known allergy to fluorescein - Pregnant or breast-feeding patients - Ongoing systemic immunosuppressive therapy with prednisolone, azathioprine or biological agents. |
Country | Name | City | State |
---|---|---|---|
Romania | Research Center of Gastroenterology and Hepatology | Craiova |
Lead Sponsor | Collaborator |
---|---|
University of Medicine and Pharmacy Craiova | Copenhagen University Hospital at Herlev |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | p-CLE findings during conventional colonoscopy and I-scan colonoscopy. | 12 months |
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