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Clinical Trials/NCT02098798
NCT02098798
Completed
Not Applicable

Comparison of Surveillance Colonoscopy Techniques in Patients With IBD

University of Calgary1 site in 1 country270 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Disease
Sponsor
University of Calgary
Enrollment
270
Locations
1
Primary Endpoint
Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
August 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Iacucci Marietta MD,PhD

Clinical Associate Professor

University of Calgary

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy

Time Frame: At the time of procedure

Study Sites (1)

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