IBD Neoplasia Surveillance RCT

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Non-Inferiority Trial Comparing Neoplasia Detection During Colonoscopy Screening With and Without Non-Targeted Biopsies in Adult Colonic Inflammatory Bowel Disease

Conditions
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Colonic Neoplasms, Inflammatory Bowel Diseases, Dysplasia

Intervention / Treatment
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* Procedure: Standard colonoscopy with targeted biopsies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Intervention Group<br>Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken. | Procedure: Standard colonoscopy with targeted biopsies<br>* Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken.<br>|
| No Intervention: Control Group<br>Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40) and targeted biopsies (and/or removal of any polyps) will be undertaken. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of persons with ≥ 1 neoplastic lesion detected |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of neoplastic lesions per person |  | 4 years | 
| Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancers detected |  | 4 years | 
| Mean # high grade dysplastic lesions or colorectal cancers per person |  | 4 years | 
| Mean # tissue samples per person |  | 4 years | 
| Mean procedure time |  | 4 years | 
| Rate of major adverse events within 2 weeks of procedure (as per pilot study) |  | 4 years | 
| Proportion of persons referred for colectomy based on neoplastic findings |  | 4 years | 
| Mean time to next recommended surveillance examination |  | 4 years | 
| CRC incidence over five years following study colonoscopy (obtained through patient linkage to provincial cancer registries five years following trial completion) |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, Dysplasia, Biopsy, Colonoscopy