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We will conduct a multicenter, parallel-group, non-inferiority RCT in persons with IBD undergoing colorectal neoplasia screening with high-definition white light colonoscopy, comparing a strategy of sampling visible lesions alone to a conventional strategy of sampling both visible lesions as well as normal-appearing mucosa using non-targeted biopsies. The primary outcome is the neoplasia detection rate. The required sample size to demonstrate non-inferiority is 1952 persons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Intervention Group | Experimental | Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any areas suspicious for neoplastic/dysplastic lesions observed by the doctor) and/or removal of any polyps will be undertaken. A limited number of disease staging biopsies from each segment of the colorectum will be permitted. |
|
| Control Group | No Intervention | Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40 non-targeted biopsies) and targeted sampling (biopsies and/or removal of suspicious pre-cancerous lesions) will be undertaken. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard colonoscopy with targeted biopsies | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of persons with ≥ 1 neoplastic lesion detected | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of neoplastic lesions per person | 4 years | |
| Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancer | 4 years | |
| Mean # high grade dysplastic lesions or colorectal cancers per person |
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Inclusion Criteria:
Each potential participant must satisfy all of the following criteria to be enrolled in the study.
≥ 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
Major purpose of colonoscopy is neoplasia screening/surveillance
Undergoing colonoscopy with high-definition white light endoscopy
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | Canada | |||
| St. Paul's Hospital |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| 4 years |
| Mean # non-targeted (random) biopsies per person | 4 years |
| Mean procedure time | 4 years |
| Rate of major adverse events within 2 weeks of procedure (as per pilot study) | 4 years |
| Mean time to next recommended surveillance examination | 4 years |
| Vancouver |
| British Columbia |
| Canada |
| University of Manitoba, Health Sciences Centre | Winnipeg | Manitoba | Canada |
| Eastern Regional Health Authority | St. John's | NFLD | A1B 3V6 | Canada |
| Nova Scotia Health Authority | Halifax | Nova Scotia | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 8E7 | Canada |
| London Health Sciences Centre, University Hospital | London | Ontario | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | Canada |
| Mount Sinai Hospital | Toronto | Ontario | Canada |
| McGill University Health Centre | Montreal | Quebec | Canada |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005759 | Gastroenteritis |