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

Status unconfirmed · Not applicable

Conditions studied: Colorectal Cancer, Colorectal Cancer Stage I

In brief

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.

Key facts

Study ID: NCT05663788
Run by: Althaia Xarxa Assistencial Universitària de Manresa
People needed: 166
Starts: 2022-07-01
Expected to finish: 2024-03-31
Last updated by the study team: 2024-02-07

Who can join

Age: 28 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

Endoscopists who have learned the invasive pattern in a centre where endoscopists have published a high diagnostic accuracy for predicting deep submucosal invasion (Japanese centres).

Where it is running

Althaia Xarxa Assistencial Universitària de Manresa — Manresa, Barcelona, Spain (enrolling)
National Cancer Center — Chūō, Tokyo, Japan
Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain
Consorci Sanitari de Terrassa — Terrassa, Barcelona, Spain
Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain
Hospital Comarcal de Alcañiz — Alcañiz, Teruel, Spain
Hospital Clínic i Provincial de Barcelona — Barcelona, Spain
Hospital Universitario Ramón y Cajal — Madrid, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital Universitari i Politècnic La Fe — Valencia, Spain
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Nottingham University Hospitals NHS Trust — Nottingham, Nottinghamshire, United Kingdom

Full record on ClinicalTrials.gov

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