Comparison of Surveillance Colonoscopy Techniques in Patients With IBD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02098798
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : August 17, 2016
Information provided by (Responsible Party):
Iacucci Marietta MD,PhD, University of Calgary

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.

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Procedure: HD Colonoscopy Procedure: HD Colonoscopy + iSCAN Procedure: HD Colonoscopy + dye spray

Study Type : Observational
Actual Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Group/Cohort Intervention/treatment
High Definition Colonoscopy alone
Procedure: HD Colonoscopy
High definition colonoscopy procedure in surveillance colonoscopy
HD colonoscopy + iSCAN
Procedure: HD Colonoscopy + iSCAN
HD + Dye
High definition colonoscopy + dye spraying chromoendoscopy
Procedure: HD Colonoscopy + dye spray

Primary Outcome Measures :
  1. Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy [ Time Frame: At the time of procedure ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inflammatory bowel disease patients undergoing surveillance colonoscopy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02098798

Canada, Alberta
University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary

Responsible Party: Iacucci Marietta MD,PhD, Clinical Associate Professor, University of Calgary Identifier: NCT02098798     History of Changes
Other Study ID Numbers: REB13-0960
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by Iacucci Marietta MD,PhD, University of Calgary:
Dysplasia, Inflammatory Bowel Disease

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases