Colonic Neoplasms, Dysplasia, Inflammatory Bowel Diseases
Conditions
Keywords
Inflammatory Bowel Disease, Dysplasia, Biopsy, Colonoscopy
Brief summary
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.
Interventions
PROCEDUREStandard colonoscopy with targeted biopsies
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.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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 * 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 who are unable to provide informed consent * Persons with a history of colorectal cancer * Persons with prior subtotal or total colectomy (\>50% of colon removed) * Persons undergoing repeat colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year * Persons undergoing pancolonic chromoendoscopy or pancolonic virtual 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 or terminal ileum \[if no cecum\]) * Moderate-to-severe inflammation (Mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (Mayo 1) involving ≥ 50% of colorectum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of persons with ≥ 1 neoplastic lesion detected | 4 years |
Secondary
| Measure | 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 | 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 |
Countries
Canada
Outcome results
None listed