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

Web-based Learning Module to Increase the Accuracy of Optical Diagnosis for Detecting the Invasive Pattern of Colorectal Polyps (LODIP Study). Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colorectal Cancer Stage I
• Intervention / Treatment: Other: E-learning module

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.

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Arnau, PhD; Phone Number: 3414 +34938759300; Email: aarnau@althaia.cat
• Study Contact Backup: Name: Anna Cano, BAJ; Phone Number: 3840 +34938759300; Email: goesresearchgroup@althaia.cat

Study Locations

• Japan
  • Tokyo
    • Chuo, Tokyo, Japan, 104-0045
      • Active, not recruiting
      • National Cancer Center
• Spain
  • Barcelona, Spain, 08036
    • Active, not recruiting
    • Hospital Clinic i Provincial de Barcelona
  • Madrid, Spain, 28041
    • Active, not recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28034
    • Active, not recruiting
    • Hospital Universitario Ramón y Cajal
  • Valencia, Spain, 46026
    • Active, not recruiting
    • Hospital Universitari i Politècnic La Fe
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Active, not recruiting
      • Hospital Germans Trias i Pujol
    • Manresa, Barcelona, Spain, 08243
      • Recruiting
      • Althaia Xarxa Assistencial Universitària de Manresa
      • Contact: Ignasi Puig del Castillo, MD, PhD; Phone Number: 3233 938742112; Email: ipuig@althaia.cat
      • Contact: Anna Cano-Català, BAJ; Phone Number: 3233 938742112; Email: info@trainingopticaldiagnosis.com
      • Principal Investigator: Ignasi Puig, MD, PhD
      • Sub-Investigator: Marco Antonio Álvarez, MD, PhD
    • Terrassa, Barcelona, Spain, 08227
      • Active, not recruiting
      • Consorci Sanitari de Terrassa
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Active, not recruiting
      • Hospital Clinico Universitario Virgen de la Arrixaca
  • Teruel
    • Alcañiz, Teruel, Spain, 44600
      • Active, not recruiting
      • Hospital Comarcal de Alcañiz
• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Active, not recruiting
      • Nottingham University Hospitals NHS Trust
• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Active, not recruiting
      • University of North Carolina At Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-learning module gastroenterologists; Gastroenterologists participating in the e-learning module	Other: E-learning module; 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.
No Intervention: Control group; Gastroenterologists not participating in the e-learning module

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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	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	immediately after the colonoscopy
Pooled benign polyps rate in lesions refered to surgery	Pooled benign polyps rate in lesions refered to surgery	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)	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	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	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	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	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	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	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	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	immediately after the colonoscopy

Collaborators and Investigators

• Sponsor: Althaia Xarxa Assistencial Universitària de Manresa
• Collaborators: Spanish Society of Digestive Endoscopy; Fundació La Marató de TV3; Asociación Española de Gastroenterología
• Investigators: Principal Investigator: Ignasi Puig, PhD, Althaia Xarxa Assistencial Universitària de Manresa

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Endoscopy. 2019 Dec;51(12):C6.
• 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. Erratum In: Endoscopy. 2020 Oct;52(10):C10.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: colonoscopy; training; colorectal polyps; chromoendoscopy; magnifying endoscopy; deep submucosal invasion; advance endoscopy; collaborative research; early colorectal cancer; optical diagnosis; invasive pattern
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CEI 19/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No