Development and Validation of a Deep Learning Algorithm for Bowel Preparation Quality Scoring
8. april 2019 oppdatert av: Xiuli Zuo, Shandong University
The purpose of this study is to develop and validate the performance of an artificial intelligence(AI) assisted Boston Bowel preparation Scoring(BBPS) system for evaluation of bowel cleanness, then testify whether this new scoring system can help physicians to improve the quality control parameters of colonoscopy in clinic practice.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
Colonoscopy is recommended as a routine examination for colorectal cancer screening.
Adequate bowel preparation is indispensable to ensure a clear vision of colonic mucosa，complete inspection of all colon segments, and furthermore improves the detection rates of small adenomas.
Thus, the adequacy of bowel preparation should be accurately evaluated and documented.
However, the accuracy of current bowel preparation quality scales greatly relies on intra-observer and inter-observer consistency for lack of objective measurements.
Recently, deep learning based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions.
While, no studies have been conducted to evaluate the performance of deep learning algorithm in bowel preparation quality scoring.
This study aims to train an algorithm to assess bowel preparation quality using the BBPS, and testify whether the engagement of AI can improve the quality control parameters of colonoscopy.
Studietype
Intervensjonell
Registrering (Forventet)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Shandong
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Jinan, Shandong, Kina, 257000
- Qilu hosipital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
• Patients aged 18-70 years undergoing afternoon colonoscopy
Exclusion Criteria:
- Known or suspected bowel obstruction, stricture or perforation
- Compromised swallowing reflex or mental status
- Severe chronic renal failure(creatinine clearance < 30 ml/min)
- Severe congestive heart failure (New York Heart Association class III or IV)
- Uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg)
- Dehydration
- Disturbance of electrolytes
- Pregnancy or lactation
- Hemodynamically unstable
- Unable to give informed consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Kunstig intelligens assisterte Scoring Group
Pasienter i denne gruppen går gjennom koloskopi under AI-overvåkingsenheten.
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After receiving standard bowel preparation regimen, patients go through colonoscopy under the AI monitoring device.
During the withdrawal process, bowel preparation quality is monitored by AI-associated scoring system.
Whenever a sub-score below 2 points is detected, endoscopist will be alarmed up to three times to wash and suck the colonic contents.
Videos will be recorded and re-evaluated by experts to determine the final BBPS score.
The withdrawal time is targeted at least 6min in accordance with colonoscopy quality practice.
All detected polyps will be removed and obtained for histological assessment, with the possible exception of diminutive(less than 5mm) rectal polyps.
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Aktiv komparator: Konvensjonell menneskelig scoringsgruppe
Pasienter i denne gruppen går gjennom konvensjonell koloskopi uten AI-overvåkingsenhet.
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After receiving standard bowel preparation regimen, patients go through conventional colonoscopy without the AI monitoring device.
During the withdrawal process, after washing and sucking the colonic contents according to endoscopist's personal experience, bowel preparation quality is evaluated by human.
Videos will be recorded and re-evaluated by experts to determine the final BBPS score.
The withdrawal time is targeted at least 6min in accordance with colonoscopy quality practice.
All detected polyps will be removed and obtained for histological assessment, with the possible exception of diminutive(less than 5mm) rectal polyps.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The rate of patients achieving adequate bowel preparation in each group.
Tidsramme: 6 months
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Bowel preparation quality was measured by BBPS.
After fully washing or suctioning of colonic contents, three segments including right colon (containing cecum and ascending colon), transvers colon (containing hepatic and splenic flexures) and left colon (containing descending and sigmoid colon) were individually scored from 0 to 3. Point 0 refers to unprepared colon segment with obscured solid stool making mucosa cannot be seen; Point 1 refers to part of mucosa can be seen, but some areas are covered by staining, residual stool, and/or opaque liquid; Point 2 refers to entire mucosa is well-seen; Point 3 refers to clean colon segment without staining, fecal materials or liquids.
A sub-score of each colon segment was used, ranging from minimum 0 to maximum 3. The highest score means the excellent bowel preparation.
Adequate bowel preparation was defined as a total BBPS≥6 and sub-BBPS≥2 per segment.
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adenoma Detection Rate
Tidsramme: 6 months
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The proportion of patients from whom at least one adenoma can be detected.
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6 months
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Polyp Detection Rate
Tidsramme: 6 months
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The proportion of patients from whom at least one polyp can be detected.
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6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. desember 2018
Primær fullføring (Forventet)
15. desember 2019
Studiet fullført (Forventet)
15. april 2020
Datoer for studieregistrering
Først innsendt
8. april 2019
Først innsendt som oppfylte QC-kriteriene
8. april 2019
Først lagt ut (Faktiske)
9. april 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2019SDU-QILU-G001
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