Status:
COMPLETED
IBD Neoplasia Surveillance Pilot RCT
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Health Sciences Centre, Winnipeg, Manitoba
Western University, Canada
Conditions:
Inflammatory Bowel Diseases
Colonic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine if random biopsies can be safely eliminated from screening of average risk persons with IBD, the investigators propose to carry out a pilot randomized control trial in which targeted biop...
Detailed Description
Inflammatory Bowel Disease (IBD), including crohn's disease and ulcerative colitis, is a group of diseases characterized by acute and chronic inflammation of the intestinal tract. Persons with IBD are...
Eligibility Criteria
Inclusion
- ≥ 18 years old
- Historical endoscopic/histologic disease extending beyond the rectum in UC or involving ≥ 1/3 of colorectum in CD
- \> 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in UC, ≥1/3 colorectum in CD
- cIBD ≥ 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis)
- In symptomatic remission at time of colonoscopy
- For CD: Harvey-Bradshaw Index \< 541
- For UC or IBDU: Partial Mayo Score ≤ 242
- Major purpose of colonoscopy is neoplasia screening/surveillance
- Undergoing colonoscopy with high-definition white light endoscopy
Exclusion
- Persons who cannot or are unwilling to provide informed consent
- Persons with a history of colorectal cancer
- Persons with prior subtotal or total colectomy (\> 50% of colon removed)
- Persons undergoing colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year
- Persons undergoing pancolonic chromoendoscopy
- Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Boston Bowel Preparation Score of 0 or 1 in any segment)
- Incomplete colonoscopy (unable to reach cecum)
- Moderate-to-severe inflammation (Mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (Mayo 1) involving ≥ 50% of colorectum
Key Trial Info
Start Date :
November 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04067778
Start Date
November 6 2020
End Date
October 6 2022
Last Update
March 31 2023
Active Locations (12)
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1
University of Alberta
Edmonton, Alberta, Canada
2
St. Paul's Hospital
Vancouver, British Columbia, Canada
3
Pacific Digestive Health / Royal Jubilee Hospital
Victoria, British Columbia, Canada
4
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, Canada