Biopsy Strategy for Inflammatory Bowel Disease
(URBI Trial)
Trial Summary
What is the purpose of this trial?
The proposed study is a multicenter parallel group clinical trial that will include 821 evaluable patients per group who will be randomly assigned to either high definition white light colonoscopy (HDWLC) with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation (limited biopsy strategy) or HDWLC with targeted biopsies plus 4 biopsies every 10 cm throughout the colon, at a minimum in all segments of the colon known to have been affected by IBD at any time, regardless of the extent of disease (random biopsy strategy). Participants will be followed until total proctocolectomy or the end of the study period to determine whether the two methods of surveillance colonoscopy are associated with detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy. Follow-up via chart review may continue for up to 15 years from enrollment.
Eligibility Criteria
This trial is for patients with certain types of Inflammatory Bowel Disease (IBD) such as Ulcerative Colitis or Crohn's affecting at least one-third of the colon, and who have had the condition for over 8 years. Participants must be due for a routine surveillance colonoscopy to check for cell changes that could lead to cancer.Inclusion Criteria
Treatment Details
Interventions
- Biopsy Strategy (Procedure)