Clinical trial NCT05663788: Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer
Official title: Web-based Learning Module to Increase the Accuracy of Optical Diagnosis for Detecting the Invasive Pattern of Colorectal Polyps (LODIP Study). Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Colorectal Cancer Stage I
Keywords: advance endoscopy
collaborative research
colonoscopy
early colorectal cancer
colorectal polyps
optical diagnosis
training
invasive pattern
magnifying endoscopy
chromoendoscopy
deep submucosal invasion
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
name: Spanish Society of Digestive Endoscopy
name: Asociación Española de Gastroenterología
First posted: 2022-12-23
Enrollment: 166
Sex: ALL
Minimum age (years): 28
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-pharmacological multi-centre, stratified (by the centre and experience, with balance randomisation \[1:1\]), randomised, controlled, parallel trial conducted in Spain.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Pooled sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in routine colonoscopies
timeFrame: immediately after the colonoscopy
Secondary outcomes:
measure: Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion
timeFrame: immediately after the colonoscopy
measure: Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion
timeFrame: immediately after the colonoscopy
measure: Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion
timeFrame: immediately after the colonoscopy
measure: Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion
timeFrame: immediately after the colonoscopy
measure: Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion
timeFrame: immediately after the colonoscopy
measure: Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion
timeFrame: immediately after the colonoscopy
measure: Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion
timeFrame: immediately after the colonoscopy
measure: Pooled en bloc resection rate in polyps containing submucosal invasion
timeFrame: immediately after the colonoscopy
measure: Pooled complete resection rate (R0) in polyps containing submucosal invasion
timeFrame: immediately after the colonoscopy
measure: Pooled benign polyps rate in lesions refered to surgery
timeFrame: immediately after the colonoscopy
measure: 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)
timeFrame: immediately after the colonoscopy
measure: Pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with piecemeal endoscopic resection
timeFrame: immediately after the colonoscopy
measure: 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
timeFrame: immediately after the colonoscopy
measure: 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
timeFrame: immediately after the colonoscopy
measure: 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
timeFrame: immediately after the colonoscopy
measure: 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
timeFrame: immediately after the colonoscopy
measure: 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
timeFrame: immediately after the colonoscopy
measure: 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
timeFrame: immediately after the colonoscopy
measure: 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
timeFrame: immediately after the colonoscopy
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Chuo
country: Japan
facility: National Cancer Center
state: Tokyo
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitària de Manresa
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: Alcañiz
country: Spain
facility: Hospital Comarcal de Alcañiz
state: Teruel
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Ignasi Puig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.
citation: Bisschops R, East JE, Hassan C, Hazewinkel Y, Kaminski MF, Neumann H, Pellise M, Antonelli G, Bustamante Balen M, Coron E, Cortas G, Iacucci M, Yuichi M, Longcroft-Wheaton G, Mouzyka S, Pilonis N, Puig I, van Hooft JE, Dekker E. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Dec;51(12):1155-1179. doi: 10.1055/a-1031-7657. Epub 2019 Nov 11.
citation: Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellise M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17.
citation: Dekker E, Houwen BBSL, Puig I, Bustamante-Balen M, Coron E, Dobru DE, Kuvaev R, Neumann H, Johnson G, Pimentel-Nunes P, Sanders DS, Dinis-Ribeiro M, Arvanitakis M, Ponchon T, East JE, Bisschops R. Curriculum for optical diagnosis training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2020 Oct;52(10):899-923. doi: 10.1055/a-1231-5123. Epub 2020 Sep 3.