- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03908645
Development and Validation of a Deep Learning Algorithm for Bowel Preparation Quality Scoring
8. april 2019 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Shandong
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Jinan, Shandong, Kina, 257000
- Qilu hosipital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Kunstig Intelligens assisterede Scoring Group
Patienter i denne gruppe gennemgår koloskopi under AI-overvågningsenheden.
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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: Konventionel menneskelig scoregruppe
Patienter i denne gruppe gennemgår konventionel koloskopi uden AI-overvågningsenhed.
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The rate of patients achieving adequate bowel preparation in each group.
Tidsramme: 6 months
|
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. december 2018
Primær færdiggørelse (Forventet)
15. december 2019
Studieafslutning (Forventet)
15. april 2020
Datoer for studieregistrering
Først indsendt
8. april 2019
Først indsendt, der opfyldte QC-kriterier
8. april 2019
Først opslået (Faktiske)
9. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2019SDU-QILU-G001
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Tarmforberedelse
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Hacettepe UniversityAfsluttetKolorektal cancer | Ammende | Koloskopi forberedelse | Boston Bowel Preparation ScaleKalkun
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Seoul National University HospitalUkendtSund og rask | Kronisk forstoppelse | Constipated Irritable Bowel Syndrome