Comparison of Surveillance Colonoscopy Techniques in Patients With IBD

NCT02098798 | Completed

• 1 other identifier: REB13-0960
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

Dysplasia, Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

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

  At the time of procedure

Study Arms (3)

HD

High Definition Colonoscopy alone

Procedure: HD Colonoscopy

HD + iSCAN

HD colonoscopy + iSCAN

Procedure: HD Colonoscopy + iSCAN

HD + Dye

High definition colonoscopy + dye spraying chromoendoscopy

Procedure: HD Colonoscopy + dye spray

Interventions

HD Colonoscopy PROCEDURE

High definition colonoscopy procedure in surveillance colonoscopy

HD

HD Colonoscopy + iSCAN PROCEDURE

HD + iSCAN

HD Colonoscopy + dye spray PROCEDURE

HD + Dye

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inflammatory bowel disease patients undergoing surveillance colonoscopy

You may qualify if:

• 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)

You may not qualify if:

• Known intraepithelial neoplasia or colorectal cancer or other neoplasia Coagulopathy which may prevent biopsies Pregnancy Inability to obtain informed consent

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary, Foothills Medical Centre

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 28, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

CA (1)