Study Results
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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COMPLETED
NA
600 participants
INTERVENTIONAL
2020-11-06
2022-10-06
Brief Summary
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Detailed Description
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In fact, recent evidence has shown that random biopsies capture a very small number of pre-cancerous lesions and that they capture such lesions only in persons with additional risk factors for CRC. In addition, new colonoscopy practices and technology have made 80-90% of pre-cancerous lesions visible. Random biopsies also carry potential risks for patients, including lower gastrointestinal bleeding and bowel perforation, and substantially increase procedural costs and time.
Hence, there is a strong impetus to conduct a well-powered non-inferiority Randomized Controlled Trial (RCT) on this topic in a Canadian setting. With the support of a pan-Canadian IBD clinical trials alliance (the Canadian IBD Research Consortium (CIRC)), and the high prevalence of IBD in Canada, Canadian investigators are well-positioned to undertake such a trial. Before embarking on a large multi-center trial, a one-year pilot feasibility trial will be conducted to ensure that patients can be enrolled efficiently with excellent protocol compliance. A feasibility trial will also provide a crude estimate of the neoplasia detection rate (primary outcome) among persons with colon IBD (cIBD) in Canada, which will allow refinement of the sample size, recruitment period and budget for a definitive trial. To-date, no well-powered or North American RCTs have evaluated random biopsies as an intervention to guide our estimates for a definitive trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Intervention Group
Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken.
Intervention Group
Standard colonoscopy with targeted biopsies only
Control Group
Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40) and targeted biopsies (and/or removal of any polyps) will be undertaken.
Control Group
Standard colonoscopy with random AND targeted biopsies
Interventions
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Intervention Group
Standard colonoscopy with targeted biopsies only
Control Group
Standard colonoscopy with random AND targeted biopsies
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Health Sciences Centre, Winnipeg, Manitoba
OTHER
Western University, Canada
OTHER
University of Toronto
OTHER
Hamilton Health Sciences Corporation
OTHER
Thunder Bay Regional Health Sciences Centre
OTHER
Eastern Health
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Providence Health & Services
OTHER
Royal Jubilee Hospital
UNKNOWN
University of Alberta
OTHER
MOUNT SINAI HOSPITAL
OTHER
Nova Scotia Health Authority
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Locations
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University of Alberta
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Pacific Digestive Health / Royal Jubilee Hospital
Victoria, British Columbia, Canada
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, Canada
Eastern Regional Health Authority
St. John's, NFLD, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Countries
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References
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Murthy SK, Marderfeld L, Fergusson D, Ramsay T, Bernstein CN, Nguyen GC, Jairath V, Riddell R. A randomized trial evaluating the utility of non-targeted biopsies for colorectal neoplasia detection in adults with inflammatory bowel disease: a pilot study protocol. Pilot Feasibility Stud. 2024 Feb 1;10(1):20. doi: 10.1186/s40814-023-01434-8.
Other Identifiers
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20190428-01T
Identifier Type: -
Identifier Source: org_study_id
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