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

NCT05663788 | Recruiting

• 1 other identifier: CEI 19/18
• Study Type: interventional
• Target: 166
• Locations: 4 countries
• Sites: 12

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  immediately after the colonoscopy

Secondary Outcomes (19)

• Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion

  immediately after the colonoscopy

• Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion

  immediately after the colonoscopy

• Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion

  immediately after the colonoscopy

• Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion

  immediately after the colonoscopy

• Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion

  immediately after the colonoscopy

Study Arms (2)

E-learning module gastroenterologists

EXPERIMENTAL

Gastroenterologists participating in the e-learning module

Other: E-learning module

Control group

NO INTERVENTION

Gastroenterologists not participating in the e-learning module

Interventions

E-learning module OTHER

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.

E-learning module gastroenterologists

Eligibility Criteria

• Age: 28 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead
• Fundació La Marató de TV3: collaborator
• Spanish Society of Digestive Endoscopy: collaborator
• Asociación Española de Gastroenterología: collaborator

Study Sites (12)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

ACTIVE NOT RECRUITING

National Cancer Center

Chūō, Tokyo, 104-0045, Japan

ACTIVE NOT RECRUITING

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

ACTIVE NOT RECRUITING

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

RECRUITING

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

ACTIVE NOT RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

ACTIVE NOT RECRUITING

Hospital Comarcal de Alcañiz

Alcañiz, Teruel, 44600, Spain

ACTIVE NOT RECRUITING

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

ACTIVE NOT RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

ACTIVE NOT RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

ACTIVE NOT RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (4)

• 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.

  PMID: 30296432 BACKGROUND

• 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.

  PMID: 31711241 BACKGROUND

• 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.

  PMID: 24639382 BACKGROUND

• 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.

  PMID: 32882737 BACKGROUND

Related Links

• website of the research group holding the e-learning platform

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ignasi Puig, PhD

  Althaia Xarxa Assistencial Universitària de Manresa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Arnau, PhD

CONTACT

+34938759300; aarnau@althaia.cat

Anna Cano, BAJ

CONTACT

+34938759300; goesresearchgroup@althaia.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Consultant, Principal Investigator

Model Details: Non-pharmacological multi-centre, stratified (by the centre and experience, with balance randomisation \[1:1\]), randomised, controlled, parallel trial conducted in Spain.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 23, 2022
• Study Start: July 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9); US (1); GB (1); JP (1)