IBD Neoplasia Surveillance RCT

Ottawa Hospital Research Institute1,411 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

1,411

Conditions

Colonic Neoplasms Inflammatory Bowel Diseases Dysplasia

Interventions

Standard colonoscopy with targeted biopsiesPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (11)

University of Alberta

Edmonton, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

University of Manitoba, Health Sciences Centre

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Proportion of persons with ≥ 1 neoplastic lesion detected

Time frame: 4 years

Secondary Outcomes

Mean number of neoplastic lesions per person

Time frame: 4 years

Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancer

Time frame: 4 years

Mean # high grade dysplastic lesions or colorectal cancers per person

Time frame: 4 years

Mean # non-targeted (random) biopsies per person

Time frame: 4 years

Mean procedure time

Time frame: 4 years

Rate of major adverse events within 2 weeks of procedure (as per pilot study)

Time frame: 4 years

Mean time to next recommended surveillance examination

Time frame: 4 years

Data from ClinicalTrials.gov

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