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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
166
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.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
ACTIVE_NOT_RECRUITINGNational Cancer Center
Chūō, Tokyo, Japan
ACTIVE_NOT_RECRUITINGHospital Germans Trias i Pujol
Badalona, Barcelona, Spain
ACTIVE_NOT_RECRUITINGAlthaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, Spain
RECRUITINGConsorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
ACTIVE_NOT_RECRUITINGHospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
ACTIVE_NOT_RECRUITINGHospital Comarcal de Alcañiz
Alcañiz, Teruel, Spain
ACTIVE_NOT_RECRUITINGHospital Clínic i Provincial de Barcelona
Barcelona, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario Ramón y Cajal
Madrid, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario 12 de Octubre
Madrid, Spain
ACTIVE_NOT_RECRUITING...and 2 more locations
Pooled sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in routine colonoscopies
Pooled sensitivity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.
Time frame: immediately after the colonoscopy
Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion
Pooled Sensitivity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.
Time frame: immediately after the colonoscopy
Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion
Pooled Specificity of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.
Time frame: immediately after the colonoscopy
Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion
Pooled ROC area of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.
Time frame: immediately after the colonoscopy
Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion
Pooled PPV of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.
Time frame: immediately after the colonoscopy
Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion
Pooled NPV of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.
Time frame: immediately after the colonoscopy
Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion
Pooled LR+ of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.
Time frame: immediately after the colonoscopy
Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion
Pooled LR- of endoscopic optical diagnosis (test assessed by Gastroenterologists according to the ESGE guidelines) for predicting deep submucosal invasion (gold standard measured by the Pathologists according to the WHO criteria) in routine colonoscopies.
Time frame: immediately after the colonoscopy
Pooled en bloc resection rate in polyps containing submucosal invasion
Pooled en bloc resection rate in polyps containing submucosal invasion found in routine colonoscopies
Time frame: immediately after the colonoscopy
Pooled complete resection rate (R0) in polyps containing submucosal invasion
Pooled complete resection rate (R0) according to the pathologist criteria in polyps containing submucosal invasion
Time frame: immediately after the colonoscopy
Pooled benign polyps rate in lesions refered to surgery
Pooled benign polyps rate in lesions refered to surgery
Time frame: immediately after the colonoscopy
Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection)
Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection)
Time frame: immediately after the colonoscopy
Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with piecemeal endoscopic resection
Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with piecemeal endoscopic resection
Time frame: immediately after the colonoscopy
Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Time frame: immediately after the colonoscopy
Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Time frame: immediately after the colonoscopy
Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Time frame: immediately after the colonoscopy
Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Time frame: immediately after the colonoscopy
Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Time frame: immediately after the colonoscopy
Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Time frame: immediately after the colonoscopy
Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion in a 20-image test before and after the learning module in the intervention group
Time frame: immediately after the colonoscopy
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