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Grant: Project Grant

Ottawa Hospital Research Institute

$650,249.00

A Randomized Controlled Non-Inferiority Trial to Assess the Utility of Non-Targeted Biopsies for Colorectal Neoplasia Detection in Adult Inflammatory Bowel Disease

FY 2022-23

Summary
Persons with inflammatory bowel disease (IBD) are at increased risk of developing colorectal cancer (CRC) and require frequent colonoscopy screening. As cancerous areas in the colorectum have historically been difficult to visualize in persons with IBD, experts recommend randomly sampling colorectal tissue during colonoscopy to identify "invisible" cancers. While this practice is now deeply rooted, there are no randomized controlled trials (RCT) to support its usefulness. Moreover, with improvements in IBD treatments, endoscopy technology and endoscopy practice quality in recent years, most cancers are now visible during colonoscopy and the yield of non-targeted biopsies is exceedingly low. Excessive colorectal tissue sampling carries potential risks of serious bleeding and bowel perforation and contributes substantially to the time and cost of performing colonoscopy in this setting. Yet, most Canadian gastroenterologists continue this practice. Therefore, high quality up-to-date evidence is needed to assess the merits and safety of this technique. In 2020, we initiated a CIHR-funded pilot study to assess the feasibility of conducting a large multicenter RCT evaluating the impact of eliminating random biopsies in this setting. In spite of the COVID-19 pandemic, we were able to well exceed our minimum recruitment target of 15% of the target sample (292/1952 persons) within 1 year and have now completed recruitment of 600 participants, with excellent protocol adherence and complete data collection. We now seek to complete this trial and analyze our outcomes of interest. The trial is being conducted by more than 30 gastroenterologists at 12 Canadian centers and is facilitated by the Canadian IBD Research Consortium. The investigative team is comprised of experts in IBD, cancer research and trial methodology. The outcomes of this study have the potential to significantly influence international practice guidelines.
Program
Project Grant
Location
Ontario, Canada
Recipient Type
Other
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
469123
Name
Murthy Sanjay K
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Nutrition, Metabolism and Diabetes
Theme2
Clinical
Prcname2
Randomized Controlled Trials
Projecttitle
A Randomized Controlled Non-Inferiority Trial to Assess the Utility of Non-Targeted Biopsies for Colorectal Neoplasia Detection in Adult Inflammatory Bowel Disease
Programtype2
Operating Grants
Orgnameinp2
Ottawa Hospital Research Institute
Cihramount2
$650,249
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Colonoscopy; Colorectal Cancer Screening; Crohn'S Disease; Inflammatory Bowel Disease; Interventional Study; Non-Inferiority Trial; Practice Utility; Randomized Controlled Trial; Tissue Sampling; Ulcerative Colitis
Abstract
Persons with inflammatory bowel disease (IBD) are at increased risk of developing colorectal cancer (CRC) and require frequent colonoscopy screening. As cancerous areas in the colorectum have historically been difficult to visualize in persons with IBD, experts recommend randomly sampling colorectal tissue during colonoscopy to identify "invisible" cancers. While this practice is now deeply rooted, there are no randomized controlled trials (RCT) to support its usefulness. Moreover, with improvements in IBD treatments, endoscopy technology and endoscopy practice quality in recent years, most cancers are now visible during colonoscopy and the yield of non-targeted biopsies is exceedingly low. Excessive colorectal tissue sampling carries potential risks of serious bleeding and bowel perforation and contributes substantially to the time and cost of performing colonoscopy in this setting. Yet, most Canadian gastroenterologists continue this practice. Therefore, high quality up-to-date evidence is needed to assess the merits and safety of this technique. In 2020, we initiated a CIHR-funded pilot study to assess the feasibility of conducting a large multicenter RCT evaluating the impact of eliminating random biopsies in this setting. In spite of the COVID-19 pandemic, we were able to well exceed our minimum recruitment target of 15% of the target sample (292/1952 persons) within 1 year and have now completed recruitment of 600 participants, with excellent protocol adherence and complete data collection. We now seek to complete this trial and analyze our outcomes of interest. The trial is being conducted by more than 30 gastroenterologists at 12 Canadian centers and is facilitated by the Canadian IBD Research Consortium. The investigative team is comprised of experts in IBD, cancer research and trial methodology. The outcomes of this study have the potential to significantly influence international practice guidelines.
Competitiondate
202209
Approvedterm2
4 yrs 6 mths
Pinamesdelim
Murthy, Sanjay K; Fergusson, Dean A
Approvedterm
4 ans 6 mois
Cihrcontribution2
~ $650,249~ $0~
Ottawa Hospital Research Institute - $650,249 Grant (… | Canada Spends