IBD Neoplasia Surveillance RCT
Inflammatory Bowel Diseases | Colonic Neoplasms | DysplasiaWe 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.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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
Lieu de l'étude
Eastern Regional Health Authority
Eastern Regional Health AuthoritySt. John's, NFLD
Canada
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Ottawa Hospital Research Institute
Ottawa Hospital Research InstituteOttawa, Ontario
Canada
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University of Manitoba, Health Sciences Centre
University of Manitoba, Health Sciences CentreWinnipeg, Manitoba
Canada
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London Health Sciences Centre, University Hospital
London Health Sciences Centre, University HospitalLondon, Ontario
Canada
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McGill University Health Centre
McGill University Health CentreMontreal, Quebec
Canada
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University of Alberta
University of AlbertaEdmonton, Alberta
Canada
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Nova Scotia Health Authority
Nova Scotia Health AuthorityHalifax, Nova Scotia
Canada
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Thunder Bay Regional Health Sciences Centre
Thunder Bay Regional Health Sciences CentreThunder Bay, Ontario
Canada
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St. Paul's Hospital
St. Paul's HospitalVancouver, British Columbia
Canada
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Hamilton Health Sciences
Hamilton Health SciencesHamilton, Ontario
Canada
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Mount Sinai Hospital
Mount Sinai HospitalToronto, Ontario
Canada
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- Étude parrainée par
- Ottawa Hospital Research Institute
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05809999