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

• Sponsor: Althaia Xarxa Assistencial Universitària de Manresa (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05663788
• Collaborator: Fundació La Marató de TV3 (Other), Spanish Society of Digestive Endoscopy (Other), Asociación Española de Gastroenterología (Other)
• Enrollment: 166
• Locations: 12
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site: 13.8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Colorectal Cancer Stage I	Other: E-learning module	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.Non-pharmacological multi-centre, stratified (by the centre and experience, with balance randomisation [1:1]), randomised, controlled, parallel trial conducted in Spain.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Mar 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pooled sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in routine colonoscopies [immediately after the colonoscopy]

   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.

Secondary Outcome Measures

1. Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion [immediately after the colonoscopy]

   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.

2. Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion [immediately after the colonoscopy]

   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.

3. Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion [immediately after the colonoscopy]

   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.

4. Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion [immediately after the colonoscopy]

   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.

5. Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion [immediately after the colonoscopy]

   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.

6. Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion [immediately after the colonoscopy]

   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.

7. Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion [immediately after the colonoscopy]

   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.

8. Pooled en bloc resection rate in polyps containing submucosal invasion [immediately after the colonoscopy]

   Pooled en bloc resection rate in polyps containing submucosal invasion found in routine colonoscopies

9. Pooled complete resection rate (R0) in polyps containing submucosal invasion [immediately after the colonoscopy]

   Pooled complete resection rate (R0) according to the pathologist criteria in polyps containing submucosal invasion

10. Pooled benign polyps rate in lesions refered to surgery [immediately after the colonoscopy]

    Pooled benign polyps rate in lesions refered to surgery

11. 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 advanced en bloc procedures (ESD, TAMIS, fullthickness resection)

12. 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 rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion in lesions treated with piecemeal endoscopic resection

13. 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 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

14. 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 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

15. 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 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

16. 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 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

17. 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 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

18. 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

19. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
2	National Cancer Center	Chuo	Tokyo	Japan	104-0045
3	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
4	Althaia Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona	Spain	08243
5	Consorci Sanitari de Terrassa	Terrassa	Barcelona	Spain	08227
6	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia	Spain	30120
7	Hospital Comarcal de Alcañiz	Alcañiz	Teruel	Spain	44600
8	Hospital Clínic i Provincial de Barcelona	Barcelona		Spain	08036
9	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
10	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
11	Hospital Universitari i Politècnic La Fe	Valencia		Spain	46026
12	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire	United Kingdom	NG5 1PB

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ignasi Puig, PhD, Althaia Xarxa Assistencial Universitària de Manresa

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

• 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.
• 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.
• 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.

• Responsible Party: Ignasi Puig, Gastroenterology Consultant, Principal Investigator, Althaia Xarxa Assistencial Universitària de Manresa
• ClinicalTrials.gov Identifier: NCT05663788
• Other Study ID Numbers: CEI 19/18
• First Posted: Dec 23, 2022
• Last Update Posted: Dec 23, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ignasi Puig, Gastroenterology Consultant, Principal Investigator, Althaia Xarxa Assistencial Universitària de Manresa: advance endoscopy; collaborative research; colonoscopy; early colorectal cancer; colorectal polyps; optical diagnosis; training; invasive pattern; magnifying endoscopy; chromoendoscopy; deep submucosal invasion
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Dec 23, 2022