IBD Neoplasia Surveillance RCT

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.

Eligibility

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

Conditions4

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