Information détaillée

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Titre du projet :

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

Chercheur principal :

Murthy, Sanjay K; Fergusson, Dean A

Co-chercheurs :

Bernstein, Charles N; Jairath, Vipul; Nguyen, Geoffrey C; Riddell, Robert H

Directeur(s) de recherche :

S/O

Établisssement payé :

Institut de recherche de l'Hôpital d'Ottawa

Établissement de recherche :

Institut de recherche de l'Hôpital d'Ottawa

Département :

S/O

Programme :

Subvention Projet

Concours (année/mois) :

202209

CEP désigné :

Essais contrôlés randomisés

Institut principal :

Nutrition, métabolisme et diabète

Thème principal :

Recherche clinique

Durée (année/mois) :

4 ans 6 mois

Contribution des IRSC :

Donateurs :

Montant :

650 249$

Équipement :

0$

Contribution du partenaire externe :

Nom du partenaire :

S/O

Montant :

S/O

Équipement :

S/O

Partenaire du candidat à l'externe :

Nom du partenaire :

S/O

Montant :

S/O

Équipement :

S/O

Partenaire externe (en nature) :

Nom du partenaire :

S/O

Montant :

S/O

Équipement :

S/O

Mots clés :

Colonoscopy; Colorectal Cancer Screening; Crohn'S Disease; Inflammatory Bowel Disease; Interventional Study; Non-Inferiority Trial; Practice Utility; Randomized Controlled Trial; Tissue Sampling; Ulcerative Colitis

Résumé :

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.

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Version :

20250311.1