Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer

Summary

International guidelines recommend deciding the treatment of colorectal lesions based on the estimated histology by endoscopic optical diagnosis. However, the theoretical and practical knowledge on optical diagnosis is not widely expanded

The mail goal of this randomised controlled trial is to compare the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps \> 20 mm assessed in routine colonoscopies of gastroenterologists attending a e-learning module (intervention group) vs gastroenterologists who do not (control group)

The main questions the study aims to answer are:

* Is the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module?
* Is the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps ≥ 20 mm assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module?
* In lesions with submucosal invasion, is the en bloc and complete resection rate (R0) increased in those gastroenterologists participating in the e-learning module?
* In lesions referred to surgery, is the pooled benign polyps rate decreased in those gastroenterologists participating in the e-learning module?
* In lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection), is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in those gastroenterologists participating in the e-learning module?
* In lesions treated with piecemeal endoscopic resection, is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in those gastroenterologists participating in the e-learning module?
* Is the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures increased after participating in the e-learning module?

The participants (or subjects of study) are gastroenterologists. They will be randomised to do the e-learning course (intervention group) or not (control group).

Researchers will compare clinical outcomes of gastroenterologists participating in the e-learning module vs gastroenterologists not participating in the e-learning module to see if:

* the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps \> 20 mm assessed in routine colonoscopies is increased.
* the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps \> 20 mm is increased.
* the en bloc and complete resection rate (R0) is increased in lesions with submucosal invasion.
* the pooled benign polyps rate decreased in lesions referred to surgery.
* the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection).
* the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in lesions treated with piecemeal endoscopic resection.
* the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures after participating is increased.

Conditions

• Colorectal Cancer
• Colorectal Cancer Stage I

Interventions

OTHER

E-learning module

The intervention is a structured e-learning module on a web-based platform (www.trainingopticaldiagnosis.com) that consists of: * 10 modules, including theoretical knowledge and multiple exercises. * 2 seminars with a tutor (after Module 5 and Module 10) * feedback from the tutor on three cases recorded by the participant. * 20-images test before and after the content described above (10 Modules, 2 seminars with tutors and feedback on three cases) All the Gastroenterologists participating in the study will predict deep submucosal invasion in their routine colonoscopies and will register clinical outcomes during 12 months. The randomisation and intervention will be conducted 6 months after starting to predict deep submucosal invasion and registering clinical outcomes.

Sponsors & Collaborators

• Fundació La Marató de TV3

  collaborator OTHER

• Spanish Society of Digestive Endoscopy

  collaborator OTHER

• Asociación Española de Gastroenterología

  collaborator OTHER

• Althaia Xarxa Assistencial Universitària de Manresa

  lead OTHER

Principal Investigators

• Ignasi Puig, PhD · Althaia Xarxa Assistencial Universitària de Manresa

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

28 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2024-03-31

Completion

2024-03-31

Countries

• United States
• Japan
• Spain
• United Kingdom

Study Locations