IBD Neoplasia Surveillance RCT

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Mar 30, 2023

Keywords

ClinConnect Summary

The IBD Neoplasia Surveillance trial is studying how to best screen for abnormal growths (neoplasms) in the colon for people with inflammatory bowel diseases (IBD), like ulcerative colitis or Crohn's disease. The trial compares two different methods: one that samples only visible abnormal areas during a colonoscopy and another that also takes samples from normal-looking areas. The main goal is to see if sampling just the visible lesions is as effective as the traditional method in detecting these growths. The trial is open to adults aged 18 and older who have had chronic IBD for at least eight years, are currently in remission, and are scheduled for a colonoscopy.

Participants in this trial can expect to undergo a high-definition colonoscopy, where doctors will examine their colon and take tissue samples as part of the screening process. To be eligible, they should not have had colorectal cancer or significant recent issues in their colon. This trial is important because it could help determine a more efficient and targeted approach to monitoring people with IBD for potential complications, which could lead to better care and outcomes in the future.

Gender

ALL

Eligibility 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