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| Name | Class |
|---|---|
| Fundació La Marató de TV3 | OTHER |
| Spanish Society of Digestive Endoscopy | OTHER |
| Asociación Española de Gastroenterología | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-learning module gastroenterologists | Experimental | Gastroenterologists participating in the e-learning module |
|
| Control group | No Intervention | Gastroenterologists not participating in the e-learning module |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-learning module | Other | The intervention is a structured e-learning module on a web-based platform (www.trainingopticaldiagnosis.com) that consists of:
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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Arnau, PhD | Contact | +34938759300 | 3414 | aarnau@althaia.cat |
| Anna Cano, BAJ | Contact | +34938759300 | 3840 | goesresearchgroup@althaia.cat |
| Name | Affiliation | Role |
|---|---|---|
| Ignasi Puig, PhD | Althaia Xarxa Assistencial Universitària de Manresa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Active, not recruiting | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30296432 | Background | 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. | |
| 31711241 |
| Label | URL |
|---|---|
| website of the research group holding the e-learning platform | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Non-pharmacological multi-centre, stratified (by the centre and experience, with balance randomisation [1:1]), randomised, controlled, parallel trial conducted in Spain.
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|
| 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 |
| National Cancer Center | Active, not recruiting | Chūō | Tokyo | 104-0045 | Japan |
| Hospital Germans Trias i Pujol | Active, not recruiting | Badalona | Barcelona | 08916 | Spain |
| Althaia Xarxa Assistencial Universitària de Manresa | Recruiting | Manresa | Barcelona | 08243 | Spain |
|
| Consorci Sanitari de Terrassa | Active, not recruiting | Terrassa | Barcelona | 08227 | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | Active, not recruiting | El Palmar | Murcia | 30120 | Spain |
| Hospital Comarcal de Alcañiz | Active, not recruiting | Alcañiz | Teruel | 44600 | Spain |
| Hospital Clínic i Provincial de Barcelona | Active, not recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario Ramón y Cajal | Active, not recruiting | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Active, not recruiting | Madrid | 28041 | Spain |
| Hospital Universitari i Politècnic La Fe | Active, not recruiting | Valencia | 46026 | Spain |
| Nottingham University Hospitals NHS Trust | Active, not recruiting | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Background |
| Bisschops R, East JE, Hassan C, Hazewinkel Y, Kaminski MF, Neumann H, Pellise M, Antonelli G, Bustamante Balen M, Coron E, Cortas G, Iacucci M, Yuichi M, Longcroft-Wheaton G, Mouzyka S, Pilonis N, Puig I, van Hooft JE, Dekker E. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Dec;51(12):1155-1179. doi: 10.1055/a-1031-7657. Epub 2019 Nov 11. |
| 24639382 | Background | Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellise M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17. |
| 32882737 | Background | Dekker E, Houwen BBSL, Puig I, Bustamante-Balen M, Coron E, Dobru DE, Kuvaev R, Neumann H, Johnson G, Pimentel-Nunes P, Sanders DS, Dinis-Ribeiro M, Arvanitakis M, Ponchon T, East JE, Bisschops R. Curriculum for optical diagnosis training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2020 Oct;52(10):899-923. doi: 10.1055/a-1231-5123. Epub 2020 Sep 3. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |