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A Novel Clinical Decision Support Tool to Predict Submucosal Invasive Cancer Within Large Non-Pedunculated Colorectal Polyps

10 de julho de 2026 atualizado por: University Hospital, Ghent

Multi-centre Evaluation of a Novel Clinical Decision Support Tool to Predict Submucosal Invasive Cancer Within Large Non-Pedunculated Colorectal Polyps - A Prospective Study

Colorectal cancer can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (>=20mm) non-pedunculated colorectal polyps (LNPCPs) require careful assessment before treatment. If submucosal invasive cancer (SMI) is present, it determines whether endoscopic treatment can be curative or whether surgery is needed. Current classification systems to detect SMI are complex, require extensive training, and are underused in non-tertiary hospitals.

A simple web-based clinical decision support tool was created using well-established parameters (presence of a demarcated area, polyp size, Paris classification, location, and granularity) to identify SMI within LNPCPs. Crucially, the tool uses only standard endoscopic imaging available in most endoscopy units.

This prospective multi-centre study evaluates the accuracy of the tool during live endoscopic assessment. Endoscopists of varying experience will assess 10 large colorectal polyps using the tool, then undergo a randomized educational intervention (either a 10-minute instructional video or a 45-minute interactive training session). They will then assess a further 10 polyps using the tool. A third set of 10 assessments at 3 months evaluates durability of learning. Accuracy is compared to expert opinion.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

Colorectal cancer (CRC) is a leading cause of death in the Western world. Large non-pedunculated colorectal polyps (LNPCPs, >=20mm) represent 2-3% of colorectal polyps and require special attention. The presence of submucosal invasive cancer (SMI) determines whether endoscopic treatment is curative or whether referral for surgery is necessary. Current endoscopic classification systems (JNET, Kudo, NICE) are complex, require specialized equipment, and extensive training, making them underused in non-tertiary practice.

A novel, freely accessible web-based clinical decision support tool (available at gieqs.com/SMI) was developed based on established risk factors for SMI: the presence and characteristics of a demarcated area within the polyp, polyp size (>=40mm), Paris classification, colonic location, and granularity. The tool uses only standard white-light and virtual chromoendoscopy available in the majority of Western endoscopy units.

This is a prospective, multi-centre study conducted across 8 centres in Belgium, the United Kingdom, Israel, and Italy. The study evaluates whether endoscopists of varying experience can accurately detect SMI within LNPCPs during live colonoscopy using this tool.

The study follows a pre-post design with randomization of the educational intervention:

Phase 1 (Pre-training): Each endoscopist assesses 10 eligible LNPCPs using a standardized assessment and creates a 1-minute standardized video of each lesion.
Educational Intervention: Endoscopists are randomly allocated (1:1) to either (a) a 10-minute non-dynamic instructional video or (b) a 45-minute interactive educational session.
Phase 2 (Post-training): Each endoscopist assesses a further 10 LNPCPs using the clinical decision support tool.
Phase 3 (Durability): At 3 months, a further 10 assessments are performed to evaluate durability of the training effect.

Expert opinion applied to standardized videos serves as the reference standard. Histopathology results are recorded for all resected specimens. An interim analysis is planned when half the required participants are enrolled.

Tipo de estudo

Observacional

Inscrição (Estimado)

886

Contactos e Locais

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Contato de estudo

Nome: David Tate
Número de telefone: +3293321063
E-mail: studiestissue.resectie@uzgent.be

Locais de estudo

Bélgica
- - Ghent, Bélgica, 9000
    - Recrutamento
    - UZ Gent
    - Contato:
      
      David Tate
      
      Número de telefone: +3293321063
      
      E-mail: studiestissue.resectie@uzgent.be

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) detected during colonoscopy or referred for endoscopic resection. Patients with sessile serrated lesions are excluded. Endoscopists must consent and complete the learning intervention. Patients must provide written informed consent for data collection. Participation is voluntary for both groups.

Descrição

Inclusion Criteria:

Endoscopist participants

Gastrointestinal endoscopists of varying abilities and grades
Endoscopists who have not previously encountered the clinical decision support tool Patient participants
Referred for colonoscopy with appropriate bowel preparation
Colorectal polyp >=20mm in size detected or referred for resection
Non-pedunculated morphology
Non-sessile serrated morphology
Signed informed consent for the procedure and trial participation

Exclusion Criteria:

Endoscopist participants:

Does not consent to inclusion
Does not undergo the learning intervention
No connection with endoscopy in gastroenterology

Patient participants:

Does not consent to data collection for the study
Video of inadequate quality as per opinion of the principal investigator

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Accuracy of Endoscopic Assessment of the Risk of Submucosal Invasive Cancer Within LNPCPs Using the Clinical Decision Support Tool Compared to Expert Opinion During Live Endoscopy Prazo: Through study completion, up to 48 months	The accuracy of each endoscopist's assessment of SMI risk using the tool, compared to expert opinion applied to a standardised video of the same procedure. Measured as sensitivity, specificity, and overall accuracy across pre-training, post-training, and 3-month durability phases.	Through study completion, up to 48 months

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Percentage of LNPCP Assessments in Which a Demarcated Area Is Correctly Detected Using the Clinical Decision Support Tool, Compared to Expert Opinion Prazo: Through study completion, up to 48 months	Endoscopists assess presence/absence of a demarcated area on a standardised endoscopic video using the SMI clinical decision support tool. Expert opinion is the reference standard (considered 100% accurate). Accuracy = proportion of assessments concordant with the expert.	Through study completion, up to 48 months
Inter-observer Agreement Among Endoscopists in Detection of a Demarcated Area Within LNPCPs, Measured by Fleiss' Kappa Prazo: Through study completion, up to 48 months	Agreement among the multiple participating endoscopists rating the same standardised endoscopic videos, quantified by Fleiss' kappa (appropriate for 3+ raters; corrects for chance agreement).	Through study completion, up to 48 months
Percentage of Demarcated Areas in Which the JNET Classification Is Correctly Determined, Compared to Expert Opinion Prazo: Through study completion, up to 48 months	Endoscopists assign the JNET (Japan NBI Expert Team) classification to the demarcated area within each LNPCP. Expert opinion is the reference standard (considered 100% accurate). Accuracy = proportion of assessments in which the endoscopist's JNET category matches the expert reference.	Through study completion, up to 48 months
Percentage of Lesions in Which Each Morphological Component (Size, Location, Granularity, Paris Classification) Is Correctly Determined, Compared to Expert Opinion Prazo: Through study completion, up to 48 months	Each morphological component is assessed by the endoscopist and compared to the expert reference standard (considered 100% accurate). Accuracy = proportion of assessments concordant with the expert, reported separately for size, location, granularity, and Paris classification.	Through study completion, up to 48 months
Correct Treatment Decision Based Upon the Tool Score (Rate of Unnecessary Surgery for Benign Disease or Unnecessary Endoscopic Treatment Requiring Subsequent Surgery) Prazo: Through study completion, up to 48 months		Through study completion, up to 48 months
Endoscopist-Reported Utility of the Clinical Decision Support Tool, Measured by a 5-point Likert-Scale Questionnaire Prazo: Through study completion, up to 48 months	Participating endoscopists complete a structured questionnaire rating the usability and perceived clinical utility of the tool on a 1-5 Likert scale (1 = not useful, 5 = very useful).	Through study completion, up to 48 months
Difference in Scoring Accuracy Before and After the Educational Intervention, Comparing a 10-minute Instructional Video Versus a 45-minute Interactive Session Prazo: Through study completion, up to 48 months		Through study completion, up to 48 months
Percentage Accuracy of SMI Detection Using the Clinical Decision Support Tool at 3 Months Post-Intervention Prazo: 3 months after educational intervention	Endoscopists perform a further 10 LNPCP assessments 3 months after the educational intervention, using the SMI clinical decision support tool. Accuracy = proportion of assessments concordant with the expert reference standard (considered 100% accurate). Compared to immediately post-intervention accuracy to assess durability of the learning effect.	3 months after educational intervention

Colaboradores e Investigadores

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Patrocinador

University Hospital, Ghent

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de outubro de 2022

Conclusão Primária (Estimado)

1 de setembro de 2030

Conclusão do estudo (Estimado)

30 de setembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de julho de 2026

Primeira postagem (Real)

15 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)