An observational study in Inflammatory Bowel Disease, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-17.
Sponsored by University of Calgary · Observational
We propose a randomized controlled study to determine the detection rates of neoplasia with high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years from diagnosis except primary sclerosing cholangitis when surveillance starts at diagnosis) CD or UC.
We hypothesized that these novel endoscopic techniques using High definition colonoscopy with virtual chromoendoscopy -iScan 2 and 3 may be superior to high definition colonoscopy alone and similar to using dye spraying chromoendoscopy for detection of dysplasia and neoplasia in patients with long standing IBD.
We will aim to demonstrate if we can avoid dye spraying during the procedure and save expense and considerable time.
In addition, we can hope to produce evidence and inform the way in which we perform surveillance colonoscopy especially without large number of multiple random biopsies but only few targeted" smart and intelligent" biopsies using high definition colonoscopy with iSCAN technique as is already the European practice in several centres.
963 studies on the registry are indexed under Intestinal Diseases; 176 are open to participants now.
This study's enrollment of 270 is above the median of 139 across 378 observational studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inflammatory bowel disease patients undergoing surveillance colonoscopy
Clinical and histological diagnosis of UC or colonic CD-extensive or pancolitis.
UC -CD Disease duration 8 years from diagnosis UC-CD with associated primary sclerosing cholangitis from diagnosis Ulcerative Colitis Activity Index Mayo score 0-1 (inactive disease) Crohn's disease Activity Index - Harvey Bradshaw score \<4 (dysplasia detection requires quiescent inflammatory bowel disease)
Exclusion Criteria:
Known intraepithelial neoplasia or colorectal cancer or other neoplasia Coagulopathy which may prevent biopsies Pregnancy Inability to obtain informed consent
High Definition Colonoscopy alone
Procedure: HD Colonoscopy
HD colonoscopy + iSCAN
Procedure: HD Colonoscopy + iSCAN
High definition colonoscopy + dye spraying chromoendoscopy
Procedure: HD Colonoscopy + dye spray
High definition colonoscopy procedure in surveillance colonoscopy
Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy
Time frame: At the time of procedure
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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University of Calgary