Comparison of Surveillance Colonoscopy Techniques in Patients With IBD

NCT ID: NCT02098798

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HD

High Definition Colonoscopy alone

HD Colonoscopy

Intervention Type PROCEDURE

High definition colonoscopy procedure in surveillance colonoscopy

HD + iSCAN

HD colonoscopy + iSCAN

HD Colonoscopy + iSCAN

Intervention Type PROCEDURE

HD + Dye

High definition colonoscopy + dye spraying chromoendoscopy

HD Colonoscopy + dye spray

Intervention Type PROCEDURE

Interventions

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HD Colonoscopy

High definition colonoscopy procedure in surveillance colonoscopy

Intervention Type PROCEDURE

HD Colonoscopy + iSCAN

Intervention Type PROCEDURE

HD Colonoscopy + dye spray

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Iacucci Marietta MD,PhD

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Calgary, Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB13-0960

Identifier Type: -

Identifier Source: org_study_id

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