Comparison of Surveillance Colonoscopy Techniques in Patients With IBD

Inflammatory Bowel Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098798
• Other study ID #: REB13-0960
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: August 16, 2016
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Procedure:
• HD Colonoscopy
High definition colonoscopy procedure in surveillance colonoscopy
• HD Colonoscopy + iSCAN

• HD Colonoscopy + dye spray

Locations

Country	Name	City	State
Canada	University of Calgary, Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy		At the time of procedure	No