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

10. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

886

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of LNPCP Assessments in Which a Demarcated Area Is Correctly Detected Using the Clinical Decision Support Tool, Compared to Expert Opinion
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Ghent

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2022

Primärer Abschluss (Geschätzt)

1. September 2030

Studienabschluss (Geschätzt)

30. September 2030

Studienanmeldedaten

Zuerst eingereicht

4. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juli 2026

Zuerst gepostet (Tatsächlich)

15. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ONZ-2022-0256

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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