Utility of Random Biopsies in Patients With Inflammatory Bowel Disease

Not Applicable

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Ulcerative Colitis
• Interventions: Other: Biopsy strategy

• Registration Number: NCT06560021
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

To maximize the yield of surveillance colonoscopy, minimize risk to patients, and deliver cost-effective care, it is imperative to resolve whether random biopsies are warranted for patients with long standing Inflammatory Bowel Disease (IBD) undergoing dysplasia and colorectal cancer (CRC) surveillance with high-definition white light colonoscopy (HDWLC). For this protocol, dysplasia surveillance refers to the process of identifying precancerous dysplasia, sessile serrated adenoma (SSA) or CRC. This protocol describes a pragmatic, multicenter randomized trial of patients with IBD undergoing dysplasia surveillance with HDWLC, the most common type of surveillance colonoscopy performed in the US, to definitively answer this question.

The primary objective of the study is to determine if HDWLC using a limited biopsy strategy is non-inferior to HDWLC using a random biopsy strategy to detect dysplasia or sessile serrated adenoma (SSA) in patients with IBD.

Secondary objectives include:

1. Determine if HDWLC using a limited biopsy strategy is superior to HDWLC with a random biopsy strategy to detect one or more dysplastic or SSA lesion in patients with IBD

2. Determine whether the number of targeted biopsies differs based on the number of random biopsies obtained.

Study Timeline

• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-19
• Study Start: 2024-12-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2028-12-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1642

Inclusion Criteria

• Diagnosis of left-sided (greater than 15 cm of disease but not beyond the splenic flexure) or extensive (extending beyond the splenic flexure) ulcerative colitis or IBD-U or colonic Crohn's disease involving at least 1/3 of the colon for at least 8 years
• Patients who are scheduled to undergo colonoscopy as part of routine care.
• At least one indication for the index colonoscopy must be to perform dysplasia surveillance.
• Has not had a colonoscopy in the last 11 months

Exclusion Criteria

• Any condition that the endoscopist feels is a contraindication to random biopsies
• History of visible (high or low grade) dysplasia not completely removed
• History of sessile serrated adenoma not completely removed
• History of colorectal cancer
• Any condition for which the endoscopist feels that pancolonic contrast or virtual chromoendoscopy is mandatory
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limited biopsy strategy	Biopsy strategy	Targeted biopsies plus 2 random biopsies in 2 segments to assess for inflammation
Random biopsy strategy	Biopsy strategy	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

Primary Outcome Measures

Name	Time	Method
number of dysplastic or SSA lesions detected per colonoscopy	At index colonoscopy	The rationale for this as the primary outcome is that it is important to detect and remove all precancerous lesions. For this outcome, the investigators will include low grade dysplasia (LGD), high grade dysplasia (HGD), SSA or CRC but not indefinite for dysplasia (IFD). Dysplasia will include both conventional and nonconventional forms of dysplasia. Although SSAs do not typically have histologic changes of dysplasia, they are considered precancerous lesions and are more difficult to detect than sporadic adenomatous polyps. The number of dysplastic or SSA lesions will be defined as the number of pathology jars containing a specimen with low-grade or high-grade dysplasia (including CRC) or serrated changes consistent with a sessile serrated adenoma-like change. Even if there are more than one biopsy sample in a jar with dysplasia or SSA, it will be counted as one location with dysplasia or SSA.

Trial Locations

Locations (4)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States