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Comparison of Surveillance Colonoscopy Techniques in Patients With IBD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iacucci Marietta MD,PhD, University of Calgary
ClinicalTrials.gov Identifier:
NCT02098798
First received: March 25, 2014
Last updated: August 16, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention
Inflammatory Bowel Disease Procedure: HD Colonoscopy Procedure: HD Colonoscopy + iSCAN Procedure: HD Colonoscopy + dye spray

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Iacucci Marietta MD,PhD, University of Calgary:

Primary Outcome Measures:
  • Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy [ Time Frame: At the time of procedure ]

Enrollment: 270
Study Start Date: March 2014
Study Completion Date: August 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HD
High Definition Colonoscopy alone
Procedure: HD Colonoscopy
High definition colonoscopy procedure in surveillance colonoscopy
HD + iSCAN
HD colonoscopy + iSCAN
Procedure: HD Colonoscopy + iSCAN
HD + Dye
High definition colonoscopy + dye spraying chromoendoscopy
Procedure: HD Colonoscopy + dye spray

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inflammatory bowel disease patients undergoing surveillance colonoscopy
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098798

Locations
Canada, Alberta
University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
  More Information

Responsible Party: Iacucci Marietta MD,PhD, Clinical Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02098798     History of Changes
Other Study ID Numbers: REB13-0960
Study First Received: March 25, 2014
Last Updated: August 16, 2016

Keywords provided by Iacucci Marietta MD,PhD, University of Calgary:
Dysplasia, Inflammatory Bowel Disease

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on August 18, 2017