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- Sperimentazione clinica NCT03761771
Artificial Intelligence Identifying Polyps in Real-world Colonoscopy
14 dicembre 2018 aggiornato da: Zhaoshen Li
Validating the Performance of Artificial Intelligence in Identifying Polyps in Real-world Colonoscopy
Recently, artificial intelligence (AI) assisted image recognition has made remarkable breakthroughs in various medical fields with the developing of deep learning and conventional neural networks (CNNs).
However, all current AI assisted-diagnosis systems (ADSs) were established and validated on endoscopic images or selected videos, while its actual assisted-diagnosis performance in real-world colonoscopy is up to now unknown.
Therefore, we validated the performance of an ADS in real-world colonoscopy, which is based on deep learning algorithm and CNNs, trained and tested in multicenter datasets of 20 endoscopy centers.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The ADS were established in changhai digestive endoscopy center to assess its efficacy in clinical practice.
The ADS automatically initiated once the ileocecal valve was pictured by the colonoscopist or the colonoscopist recorded any image of colon during the insertion.
When colonoscopists withdrew the colonoscopies and inspect the colons, the video streaming of colonoscopies was real-time switched to the ADS, which made it feasible to identify and classify lesions in real time.
Colonoscopists were invited to respond if they doubted potential polyps in the screen, and the ADS also made a voice when identifying potential polyps, followed by repeatedly inspecting to confirm the existence of lesions.
The voice of ADS could be real-time heard by colonoscopists, while the screen of ADS was placed right behind colonoscopists, where polyps identified by ADS could be seen after the colonoscopists' turning but not simultaneously.
The lesion detection by ADS or colonoscopists were determined as follow: A. polyps only identified by ADS, which was considered to be missed by colonoscopists: polyps were reported by the ADS and the colonoscopists did not know the location of polyps without reminder of the ADS until the polyps disappeared from the view; B. polyps first identified by ADS: polyps were first reported by the ADS and the colonoscopists also later knew the location of polyps by themselves; C. polyps simultaneously identified by the ADS and colonoscopists: the time of reporting polyps was closely synchronal (within 1 second); D. polyps first reported by colonoscopists: polyps were first reported by the colonoscopists and the ADS also later identified the location of polyps before the colonoscopists unfolded and pictured the polyps; E. polyps only reported by colonoscopists, which was considered to be missed by the ADS: polyps were reported by the colonoscopists and the ADS did not identify the location of polyps until colonoscopists unfolded and pictured the polyps.
Besides, the false-positives of real-world ADS were also reported with potential causes analyzed by colonoscopists.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
209
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Shanghai, Cina, 200433
- Changhai Hospital, Second Military Medical University
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Shanghai, Cina, 200433
- Changhai Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
consecutive outpatient who recieved colonoscopy
Descrizione
Inclusion Criteria:
- patients receiving screening colonoscopy
- patients receiving surveillance colonoscopy
- patients receiving diagnostic colonoscopy
Exclusion Criteria:
- patients with declined consent
- patients with poor bowel preparation
- patients with failed cecal intubation
- patients with colonic resection
- patients with inflammatory bowel diseases
- patients with polyposis
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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colonoscopy withdrawal with the ADS monitoring
The ADS automatically initiated once the ileocecal valve was pictured by the colonoscopist or the colonoscopist recorded any image of colon during the insertion.
When colonoscopists withdrew the colonoscopies and inspect the colons, the video streaming of colonoscopies was real-time switched to the ADS, which made it feasible to identify and classify lesions in real time.
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During the testing of trained ADS, when the system doubts colonic lesions from the input data of the test images, a rectangular frame was displayed in the endoscopic image to surround the lesion.
If the system confirmed it as the colonic lesions, a sound of reminder will be played and the types of lesions (non-adenomatous polyps, adenomatous polyps and colorectal cancers) will be classified by the system.
We adopted several standards to define the identification and classification of colonic lesions: 1) when the system identified and confirmed any lesion in the images of no polyps or cancers, the results were judged to be false-positive.
2) when the system both confirmed and correctly localized the lesions in images (IoU > 0.3), the results were judged to be true-positive.
3) when the system did not confirm or correctly localize the lesions, the results were judged as false-negative.
4) when system confirmed no lesions in the normal images, the results were judged to be true-negative.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
sensitivity of the ADS in identifying polyps
Lasso di tempo: 1 hour
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Polyps that were only reported by colonoscopists were considered to be missed by the ADS (polyps were reported by the colonoscopists and the ADS did not identify the location of polyps until colonoscopists unfolded and pictured the polyps.)
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1 hour
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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false positves of the ADS per colonoscopy withdrawal
Lasso di tempo: 1 hour
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when the system identified and confirmed any lesion in the images with no polyps or cancers appearing, the results were judged to be false-positive.
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1 hour
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Byrne MF, Chapados N, Soudan F, Oertel C, Linares Perez M, Kelly R, Iqbal N, Chandelier F, Rex DK. Real-time differentiation of adenomatous and hyperplastic diminutive colorectal polyps during analysis of unaltered videos of standard colonoscopy using a deep learning model. Gut. 2019 Jan;68(1):94-100. doi: 10.1136/gutjnl-2017-314547. Epub 2017 Oct 24.
- Wang Z, Meng Q, Wang S, Li Z, Bai Y, Wang D. Deep learning-based endoscopic image recognition for detection of early gastric cancer: a Chinese perspective. Gastrointest Endosc. 2018 Jul;88(1):198-199. doi: 10.1016/j.gie.2018.01.029. No abstract available.
- Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.
- Wang Z, Zhao S, Bai Y. Artificial Intelligence as a Third Eye in Lesion Detection by Endoscopy. Clin Gastroenterol Hepatol. 2018 Sep;16(9):1537. doi: 10.1016/j.cgh.2018.04.032. No abstract available.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 novembre 2018
Completamento primario (Effettivo)
10 dicembre 2018
Completamento dello studio (Effettivo)
10 dicembre 2018
Date di iscrizione allo studio
Primo inviato
30 novembre 2018
Primo inviato che soddisfa i criteri di controllo qualità
30 novembre 2018
Primo Inserito (Effettivo)
3 dicembre 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 dicembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 dicembre 2018
Ultimo verificato
1 dicembre 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AI-1
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
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 .