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Comparison of Surveillance Colonoscopy Techniques in Patients With IBD

U

University of Calgary

Status

Completed

Conditions

Inflammatory Bowel Disease

Treatments

Procedure: HD Colonoscopy
Procedure: HD Colonoscopy + iSCAN
Procedure: HD Colonoscopy + dye spray

Study type

Observational

Funder types

Other

Identifiers

NCT02098798
REB13-0960

Details and patient eligibility

About

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.

Enrollment

270 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

270 participants in 3 patient groups

HD
Description:
High Definition Colonoscopy alone
Treatment:
Procedure: HD Colonoscopy
HD + iSCAN
Description:
HD colonoscopy + iSCAN
Treatment:
Procedure: HD Colonoscopy + iSCAN
HD + Dye
Description:
High definition colonoscopy + dye spraying chromoendoscopy
Treatment:
Procedure: HD Colonoscopy + dye spray

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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