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Grant: Project Grant

Ottawa Hospital Research Institute

$298,351.00

A Randomized, Parallel-Group, Open Label, Non-Inferiority, Pragmatic Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Detection During Screening Colonoscopy in Adult Persons with Colonic Inflammatory Bowel Diseases: A Pilot Study

FY 2017-18

Summary
Persons with inflammatory bowel diseases (IBD) are at increased risk of colorectal cancer (CRC) and require frequent CRC screening with colonoscopy. Colorectal tumours can be more difficult to visualize in persons with IBD than in persons without IBD. Therefore, IBD experts have long recommended a strategy of taking 30 to 40 random biopsies to help detect these lesions during screening colonoscopy. Oddly, there have never been high quality studies demonstrating the usefulness of this practice. Recent literature suggests that random biopsies have an exceedingly low rate of detecting tumours in persons with IBD and that improved technology and practice have made 80 to 90% of colorectal tumours visible. Since random biopsies pose potential risks, such as lower gastrointestinal bleeding and bowel perforation, and substantially increase procedural time and costs, it is important to determine whether this practice is still merited. We ultimately wish to conduct a large, multi-center randomized controlled trial to evaluate whether the practice of taking random biopsies during colonoscopy can be avoided without increasing the risk of developing CRC faced by IBD patients. However, we first propose a smaller-scale pilot study that will evaluate our ability to recruit patients, the rate at which colon lesions are detected, and adherence to the study protocol by investigators, which will inform the capacity and requirements to conduct a full-scale trial. The pilot study aims to recruit 400 patients at 12 academic IBD centers over one year. If we are able to proceed with the full-scale trial, based on the pilot study findings, it could lead to a major advance in IBD patient care. If avoidance of random biopsies during colonoscopy screening is not found to be harmful to patients in the full trial, it would enable practitioners to abandon this practice, which could substantially reduce the risks, time and costs associated with screening colonoscopy in persons with IBD.
Program
Project Grant
Location
Ontario, Canada
Recipient Type
Other
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
379402
Name
Murthy Sanjay K
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Nutrition, Metabolism and Diabetes
Theme2
Clinical
Prcname2
Clinical Investigation - C: Digestive, Endocrine and Excretory Systems
Projecttitle
A Randomized, Parallel-Group, Open Label, Non-Inferiority, Pragmatic Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Detection During Screening Colonoscopy in Adult Persons with Colonic Inflammatory Bowel Diseases: A Pilot Study
Programtype2
Operating Grants
Orgnameinp2
Ottawa Hospital Research Institute
Cihramount2
$298,351
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Colorectal Cancer; Dysplasia; Endoscopy; Inflammatory Bowel Diseases; Randomized Controlled Trial; Screening
Abstract
Persons with inflammatory bowel diseases (IBD) are at increased risk of colorectal cancer (CRC) and require frequent CRC screening with colonoscopy. Colorectal tumours can be more difficult to visualize in persons with IBD than in persons without IBD. Therefore, IBD experts have long recommended a strategy of taking 30 to 40 random biopsies to help detect these lesions during screening colonoscopy. Oddly, there have never been high quality studies demonstrating the usefulness of this practice. Recent literature suggests that random biopsies have an exceedingly low rate of detecting tumours in persons with IBD and that improved technology and practice have made 80 to 90% of colorectal tumours visible. Since random biopsies pose potential risks, such as lower gastrointestinal bleeding and bowel perforation, and substantially increase procedural time and costs, it is important to determine whether this practice is still merited. We ultimately wish to conduct a large, multi-center randomized controlled trial to evaluate whether the practice of taking random biopsies during colonoscopy can be avoided without increasing the risk of developing CRC faced by IBD patients. However, we first propose a smaller-scale pilot study that will evaluate our ability to recruit patients, the rate at which colon lesions are detected, and adherence to the study protocol by investigators, which will inform the capacity and requirements to conduct a full-scale trial. The pilot study aims to recruit 400 patients at 12 academic IBD centers over one year. If we are able to proceed with the full-scale trial, based on the pilot study findings, it could lead to a major advance in IBD patient care. If avoidance of random biopsies during colonoscopy screening is not found to be harmful to patients in the full trial, it would enable practitioners to abandon this practice, which could substantially reduce the risks, time and costs associated with screening colonoscopy in persons with IBD.
Competitiondate
201803
Approvedterm2
2 yrs 0 mth
Pinamesdelim
Murthy, Sanjay K; Fergusson, Dean A
Approvedterm
2 ans 0 mois
Cihrcontribution2
~ $298,351~ $0~