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RecruitingNCT05663788LODIPUpdated Feb 7, 2024

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

An interventional study of E-learning module in Colorectal Cancer and Colorectal Cancer Stage I, sponsored by Althaia Xarxa Assistencial Universitària de Manresa. Recruiting at 12 sites in 4 countries. Open to participants aged 28 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Althaia Xarxa Assistencial Universitària de Manresa · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Jul 2022, registered Dec 2022).
  • Started Jul 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
28 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • 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
03

In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 166 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
166 participants (estimated)

Study arms

  • Experimental
    E-learning module gastroenterologists

    Gastroenterologists participating in the e-learning module

    Other: E-learning module

  • No intervention
    Control group

    Gastroenterologists not participating in the e-learning module

Interventions

  • OtherE-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.

06

What researchers measure

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.

    Time frame: immediately after the colonoscopy

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Pooled benign polyps rate in lesions refered to surgery

    Pooled benign polyps rate in lesions refered to surgery

    Time frame: immediately after the colonoscopy

  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)

    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

  12. 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

  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

    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

  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

    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

  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

    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

  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

    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

  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

    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

  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

    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

  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

    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

07

Study locations

1 of 12 sites recruiting
08

References and documents

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. PubMed 30296432 ↗
  • 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. doi: 10.1055/a-1074-5788. PubMed 31711241 ↗
  • 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. PubMed 24639382 ↗
  • 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. doi: 10.1055/a-1264-2634. PubMed 32882737 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05663788
Lead sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Collaborators
Fundació La Marató de TV3, Spanish Society of Digestive Endoscopy, Asociación Española de Gastroenterología
Responsible party
Ignasi Puig (Gastroenterology Consultant, Principal Investigator, Althaia Xarxa Assistencial Universitària de Manresa) — Principal investigator
First posted
Dec 23, 2022
Start date
Jul 1, 2022
Primary completion
Mar 31, 2024 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Feb 7, 2024

Study contacts

Anna Arnau, PhD
Contact
aarnau@althaia.cat
+34938759300 ext. 3414
Anna Cano, BAJ
Contact
goesresearchgroup@althaia.cat
+34938759300 ext. 3840
Ignasi Puig, PhD
principal investigator · Althaia Xarxa Assistencial Universitària de Manresa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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