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IBD Neoplasia Surveillance RCT

Inflammatory Bowel Diseases | Colonic Neoplasms | Dysplasia

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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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

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

Study Location

Eastern Regional Health Authority
Eastern Regional Health Authority
St. John's, NFLD
Canada

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Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Ottawa, Ontario
Canada

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University of Manitoba, Health Sciences Centre
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba
Canada

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London Health Sciences Centre, University Hospital
London Health Sciences Centre, University Hospital
London, Ontario
Canada

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McGill University Health Centre
McGill University Health Centre
Montreal, Quebec
Canada

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University of Alberta
University of Alberta
Edmonton, Alberta
Canada

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Nova Scotia Health Authority
Nova Scotia Health Authority
Halifax, Nova Scotia
Canada

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Thunder Bay Regional Health Sciences Centre
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
Canada

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St. Paul's Hospital
St. Paul's Hospital
Vancouver, British Columbia
Canada

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Hamilton Health Sciences
Hamilton Health Sciences
Hamilton, Ontario
Canada

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Primary Contact

Jane Castelli

[email protected]
289-880-3609
Mount Sinai Hospital
Mount Sinai Hospital
Toronto, Ontario
Canada

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Study Sponsored By
Ottawa Hospital Research Institute
Participants Required
More Information
Study ID: NCT05809999