OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD

NCT04924543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2022-05-18

No results posted yet for this study

Summary

People with inflammatory bowel diseases (IBD) can be at higher risk of developing abnormal areas in their bowel. These abnormal areas can be due to active inflammation, healed inflammation, polyps or pre-cancerous changes ("dysplasia"). It is for this reason that people with IBD are offered periodic surveillance colonoscopy procedures to identify, characterize and where necessary remove abnormal areas or lesions from the bowel. These can be difficult to characterize correctly, which is important to make the correct endoscopic diagnosis and management plan. Technical advancements in endoscopy mean that more tools are available to identify and characterize these lesions in real time during colonoscopy. Specialists regularly performing gastrointestinal endoscopy and colonoscopy ("endoscopists") will often receive special training, both during their initial postgraduate training and through continuous professional development programs.

This study aims to evaluate whether an online training platform can improve the ability of endoscopists to characterize dysplasia in IBD. The goal is to support improved decision-making during IBD surveillance, reporting of dysplastic lesions, and ultimately the care and outcomes of people with IBD.

Conditions

  • Inflammatory Bowel Diseases
  • Dysplasia Colon
  • Dysplasia, Crohn Disease-Associated
  • Polyp of Colon
  • Ulcerative Colitis
  • Crohn Colitis
  • Crohn Disease

Interventions

OTHER

Online self-learning training module

Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

OTHER

Refresher training

Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER
  • University of Milan

    collaborator OTHER
  • Federico II University

    collaborator OTHER
  • University of Bari Aldo Moro

    collaborator OTHER
  • University of Birmingham

    lead OTHER

Principal Investigators

  • Marietta Iacucci, MD PhD · University of Birmingham

  • Jose G Ferraz, MD PhD · University of Calgary

  • Gian E Tontini, MD PhD · University of Milan

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2021-12-20
Completion
2022-04-30

Countries

  • Canada
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04924543 on ClinicalTrials.gov