Comparison of Surveillance Colonoscopy Techniques in Patients With IBD

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Procedure: HD Colonoscopy; Procedure: HD Colonoscopy + iSCAN; Procedure: HD Colonoscopy + dye spray

• Registration Number: NCT02098798
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-28
• Primary Completion: 2016-04
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HD	HD Colonoscopy	High Definition Colonoscopy alone
HD + iSCAN	HD Colonoscopy + iSCAN	HD colonoscopy + iSCAN
HD + Dye	HD Colonoscopy + dye spray	High definition colonoscopy + dye spraying chromoendoscopy

Primary Outcome Measures

Name	Time	Method
Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy	At the time of procedure

Trial Locations

Locations (1)

University of Calgary, Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada