- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05191095
The Accuracy of Human Endoscopic Detection of Submucosal Invasive Cancer in Colorectal Polyps
The Accuracy of Human Endoscopic Detection of Submucosal Invasive Cancer in Colorectal Polyps - Analysis of 739 Individual Assessments of Large Non-pedunculated Colorectal Polyps Using a Novel Clinical Decision Support Tool
Colorectal cancer (CRC) is a leading cause of death in the Western world. It can be effectively prevented by removal of pre-malignant polyps (polypectomy) during colonoscopy. Large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) represent 2-3% of colorectal polyps, and require special attention prior to treatment. If submucosal invasion (SMI) is suspected careful decision making is required to exclude features which unacceptably increase the risk of lymph node metastases and render local treatment (endoscopic) non-curative. Such patients require a multi-disciplinary approach and consideration of surgery +/- systemic therapy.
Recently the endoscopic imaging characteristics which precisely determine the risk of SMI within colon polyps have been elucidated. This suggests endoscopic imaging may be the ideal investigation to stratify the presence and extent of SMI within LNPCP, particularly as it can be applied in real-time at the time of planned endoscopic treatment.
Unfortunately, current classification systems are complex, require extensive training and technology not available in the majority of non-tertiary hospitals. They are therefore underused leading to incorrect decision making and negative patient outcome (e.g piecemeal resection without the chance of endoscopic cure or unnecessary further procedures in referral centres with resultant surgery anyway or surgery for benign disease)
A simple clinical support tool was created, based on well-established parameters (i.e., presence of a demarcated area within a polyp, size of the polyp, Paris classification, location within the colon and granularity) to identify OVERT (visible on the surface) and COVERT (hidden) submucosal invasion (SMI) within LNPCPs. Crucially this tool only uses what is reproducible in the majority of endoscopy units in the Western world (i.e. standard magnification, no extra chromic dyes etc). predict SMI within LNPCPs and we translated it into a single web-based clinical support tool that can be used by every endoscopist (expert and non-expert).
To evaluate the tool, a survey will be send to participants. The survey consist of a 10-minute educational video where the use of the tool will be explained. Then 20 standardised videos of LNPCPs will be shown. Participants are first asked about their first impression regarding the presence of SMI. Then they are redirected to the web-based tool. After filling the required data from a standardised video (45 seconds to minute, no focus on one particular area of the polyp) the score generated by our tool is copied to the participants computer clipboard and then pasted in the survey so that we could analyse it.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Ghent, Belgio, 9000
- UZ Gent
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Gastrointestinal endoscopic experience (trainees, student, gastroenterologist consult, surgeon)
Exclusion Criteria:
- No connection with endoscopy in gastroenterology
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs from a standardised endoscopic video, using a novel, freely accessible, web-based simple clinical decision support tool as versus expert opinion.
Lasso di tempo: 30 minutes
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Can participants, using the tool, identify SMI within LNPCPs?
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30 minutes
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The inter-observer agreement of a novel simple clinical decision support tool to determine the risk of SMI within LNPCPs from a standardised endoscopic video as versus expert opinion.
Lasso di tempo: 30 minutes
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Are participants able to derive characteristic information from polyps (size, Paris classification, granularity, pit/vascular pattern) using a standardised video of LNPCPs
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30 minutes
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: David Tate, UZ Gent
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BC-09381 + E01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .