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

Last updated: February 6, 2024
Sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer; Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

E-learning module

Clinical Study ID

NCT05663788
CEI 19/18
  • Ages > 28
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gastroenterologists who have performed > 300 colonoscopies without supervision and arein the last training year or had finished the Gastroenterology residency after 2014.

Exclusion

Exclusion Criteria:

  • Endoscopists who have learned the invasive pattern in a centre where endoscopists havepublished a high diagnostic accuracy for predicting deep submucosal invasion (Japanesecentres).

Study Design

Total Participants: 166
Treatment Group(s): 1
Primary Treatment: E-learning module
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
March 31, 2024

Study Description

Non-pharmacological multi-centre randomised controlled trial. Gastroenterologists who have performed > 300 colonoscopies without supervision and who have finished/will finish the residency in Gastroenterology between 2014 and 2023 will be invited to participate. Gastroenterologists participating in the study will register the optical diagnosis, endoscopic lesions' characteristics, histology and clinical outcomes of consecutive non-pedunculated lesions ≥ 20 mm found in routine colonoscopies during a whole year. Participants allocated in the intervention group will receive a learning module after six months. Those assigned in the control group will not receive any learning module (they will be offered to do it at the end of the study). Pooled sensitivity and diagnostic accuracy of optical diagnosis for predicting deep submucosal invasion, and clinical outcomes in routine colonoscopies will be compared in both groups. Diagnostic accuracy for predicting deep submucosal invasion in a test with pictures before and after participating will also be compared.

Connect with a study center

  • National Cancer Center

    Chuo, Tokyo 104-0045
    Japan

    Site Not Available

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Althaia Xarxa Assistencial Universitària de Manresa

    Manresa, Barcelona 08243
    Spain

    Active - Recruiting

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona 08227
    Spain

    Site Not Available

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia 30120
    Spain

    Site Not Available

  • Hospital Comarcal de Alcañiz

    Alcañiz, Teruel 44600
    Spain

    Site Not Available

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

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