Colorectal CancerLODIPNCT05663788
Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer
A study testing E-learning module in people with Colorectal Cancer and Colorectal Cancer Stage I, run by Althaia Xarxa Assistencial Universitària de Manresa at 12 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 28 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Cancer Stage I
- What is being tested?
- E-learning module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 1 Jul 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gastroenterologists who have performed > 300 colonoscopies without supervision and are in the last training year or had finished the Gastroenterology residency after 2014.
Who cannot join
- 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).
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Spain9 sites, 1 recruiting
- Active, not recruiting
Hospital Comarcal de Alcañiz
Alcañiz, Teruel, 44600
- Active, not recruiting
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
- Active, not recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
- Active, not recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
- Active, not recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
Ignasi Puig del Castillo, MD, PhD, 938742112 ext. 3233, ipuig@althaia.cat
Anna Cano-Català, BAJ, 938742112 ext. 3233, info@trainingopticaldiagnosis.com
- Active, not recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
- Active, not recruiting
Hospital Universitari i Politècnic La Fe
Valencia, 46026
United States1 site
- Active, not recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United Kingdom1 site
- Active, not recruiting
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB
About this study
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
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)
Read more
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.
- Conditions
- Colorectal Cancer, Colorectal Cancer Stage I
- Being tested
- E-learning module
- Keywords
- advance endoscopy, collaborative research, colonoscopy, early colorectal cancer, colorectal polyps, optical diagnosis, training, invasive pattern, magnifying endoscopy, chromoendoscopy, deep submucosal invasion
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learning moduleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| E-learning module gastroenterologists | Experimental | Gastroenterologists participating in the e-learning module Receives: Other: E-learning module |
| Control group | No intervention | Gastroenterologists not participating in the e-learning module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the colonoscopy
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: immediately after the colonoscopy
Pooled benign polyps rate in lesions refered to surgery
Pooled benign polyps rate in lesions refered to surgery
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: immediately after the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Jul 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3, Spanish Society of Digestive Endoscopy, Asociación Española de Gastroenterología
- Responsible party
- Principal investigator, Ignasi Puig, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Ignasi Puig, PhD, Principal investigator, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663788
- Sponsor's protocol ID
- CEI 19/18
- Acronym
- LODIP
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30296432Bisschops 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.
PubMed 31711241Kaminski 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 24639382Dekker 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.
PubMed 32882737
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05663788
- Acronym / sponsor ID
- LODIP / CEI 19/18
- Conditions
- Colorectal Cancer, Colorectal Cancer Stage I
- Keywords
- advance endoscopy, collaborative research, colonoscopy, early colorectal cancer, colorectal polyps, optical diagnosis, training, invasive pattern
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3, Spanish Society of Digestive Endoscopy, Asociación Española de Gastroenterología
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-pharmacological multi-centre, stratified (by the centre and experience, with balance randomisation [1:1]), randomised, controlled, parallel trial conducted in Spain.
| Arm | Type | Receives |
|---|---|---|
| E-learning module gastroenterologists | Experimental | Other: E-learning moduleGastroenterologists participating in the e-learning module |
| Control group | No intervention | –Gastroenterologists not participating in the e-learning module |
Who may qualify
- Ages
- 28 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gastroenterologists who have performed > 300 colonoscopies without supervision and are in the last training year or had finished the Gastroenterology residency after 2014.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-learning moduleThe 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. | Other | E-learning module gastroenterologists |
Primary outcome
Pooled sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in routine colonoscopies
Time frame: 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.
19 secondary outcomes
Pooled Sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion
Time frame: immediately after the colonoscopy
Pooled Specificity of endoscopic optical diagnosis for predicting deep submucosal invasion
Time frame: immediately after the colonoscopy
Pooled ROC area of endoscopic optical diagnosis for predicting deep submucosal invasion
Time frame: immediately after the colonoscopy
Pooled PPV of endoscopic optical diagnosis for predicting deep submucosal invasion
Time frame: immediately after the colonoscopy
Pooled NPV of endoscopic optical diagnosis for predicting deep submucosal invasion
Time frame: immediately after the colonoscopy
Pooled LR+ of endoscopic optical diagnosis for predicting deep submucosal invasion
Time frame: immediately after the colonoscopy
Pooled LR- of endoscopic optical diagnosis for predicting deep submucosal invasion
Time frame: immediately after the colonoscopy
Pooled en bloc resection rate in polyps containing submucosal invasion
Time frame: immediately after the colonoscopy
Pooled complete resection rate (R0) in polyps containing submucosal invasion
Time frame: immediately after the colonoscopy
Pooled benign polyps rate in lesions refered to surgery
Time frame: 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)
Time frame: immediately after the colonoscopy
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 30296432Puig 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.
- Background: PubMed 31711241Bisschops 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.
- Background: PubMed 24639382Kaminski 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.
- Background: PubMed 32882737Dekker 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.
- website of the research group holding the e-learning platformLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignasi Puig, PhD principal investigator
Althaia Xarxa Assistencial Universitària de Manresa
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-learning module in people with Colorectal Cancer and Colorectal Cancer Stage I, run by Althaia Xarxa Assistencial Universitària de Manresa at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, United States, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Arnau, PhD (+34938759300 ext. 3414, aarnau@althaia.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pooled sensitivity of endoscopic optical diagnosis for predicting deep submucosal invasion in routine colonoscopies (time frame: immediately after the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05663788, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.