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

10. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

886

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of LNPCP Assessments in Which a Demarcated Area Is Correctly Detected Using the Clinical Decision Support Tool, Compared to Expert Opinion
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Hospital, Ghent

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. října 2022

Primární dokončení (Odhadovaný)

1. září 2030

Dokončení studie (Odhadovaný)

30. září 2030

Termíny zápisu do studia

První předloženo

4. června 2026

První předloženo, které splnilo kritéria kontroly kvality

10. července 2026

První zveřejněno (Aktuální)

15. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ONZ-2022-0256

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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