USAGE OF ARITIFICIAL INTELLIGENCE IN AIDING WITH COLONIC SESSILE SERRATED LESIONS DETECTION AND DIAGNOSIS (AI-SSL) (AI-SSLD)
USAGE OF ARITIFICIAL INTELLIGENCE IN AIDING WITH COLONIC SESSILE SERRATED LESIONS DETECTION AND DIAGNOSIS (AI-SSLD)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The serrated pathway is believed to account for 30% of all colorectal cancers (CRC). However, as detection rates vary widely among endoscopists and pathologists, there is uncertainty about the prevalence of these lesions [1]. Prevalence varies with study location, diagnostic criteria and examination quality. Relatively little is known about the epidemiology of these lesions (prevalence, location, family history) and risk of malignant transformation (timing, associated factors). A systematic review reported prevalence of sessile serrated lesions (SSL) was 3.9% in Europe and 5.1% in the US.
In Asia, only few reports on Sessile Serrated lesion (SSL) have been published. In a CRC screening study from Hong Kong recruiting 6,011 subjects, 486 (8.1%) subjects were reported to have HPs and only 85 (1.4%) SSL [2]. A study from Japan recruiting 5,218 asymptomatic subjects for CRC screening reported detection rates of serrated lesions of 23.3% and of right-sided serrated lesions of 7.6% respectively [3]. In this study, high-quality video endoscopes with narrow-band imaging (NBI) and magnification were used with 0.4% indigo carmine dye to enhance the detection of flat lesions. On the other hand, In Australia, the prevalence of SSL in Chinese (2%) was lower when compared with Caucasian (7%) subjects [4]. Studies have shown that SSLs are associated with CRC, especially those on the right colon and in the elderly age group, and hence should be detected and remove.[5] In addition to the potential for malignant transformation of SSL, individuals with these lesions are reportedly at higher risk of development of synchronous and metachronous CRC and advanced colorectal neoplasia (ACN) at other sites. [6-8]
Training for endoscopists and pathologists to identify SSL will likely increase detection rates, improve the prevalence of estimates of these lesions and hence reduce the incidence of interval post-colonoscopy colorectal cancer [9] The high variability between studies on the SSL prevalence, is at least partly explained by varying detection rates of serrated lesions between endoscopists, as this rate appears highly operator dependent.
Currently, CADe has been shown to improve adenoma detection rate by around 30%.[10] With the existing algorithm, SSL detection has not been improved irrespective of endoscopist experience, system type or healthcare setting. [11] This is because focus has always been put on adenomatous polyps. SSLs are sessile or flat lesions measuring average size 5-7mm and can be easily missed during conventional colonoscopy as they are usually normal to pale in color They may exhibit distinct endoscopic features such as overlying mucus cap, cloud-like surface, ring of debris or stool around the lesion and obscured mucosal vasculature During narrow-band imaging endoscopy, they have a cloud-like appearance, irregular shape, and dark spots inside the crypts. Better bowel preparation, longer withdrawal time, and careful examination of the right colon (with repeated anterograde examination or retroflexion in the caecum) improved detection of SSL [12]. Electronic chromoendoscopy such as NBI may marginally improve the detection of SSL but is currently not recommended as mandatory practice, because clear scientific evidence is lacking.
Usage of CADe system has been shown in several studies to improve polyp detection rate even amongst junior endoscopists but however most of the CADE system is trained to focus on adenomatous polyp. This AI algorithm has been trained to detect SSL. If proven to be effective in a real-world setting, this will improve outcomes of patients undergoing colonoscopies and reduce the risk of interval colon cancers post colonoscopies.
We hypothesise that usage of CADe system can improve SSL detection significantly from 2% with conventional White Light endoscopy to 6.5%.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Weida Chew, Masters
- Telefonnummer: 63577897
- E-Mail: wei.da.chew@nhghealth.com.sg
Studieren Sie die Kontaktsicherung
- Name: Aei Aei Zaw
- Telefonnummer: 63573116
- E-Mail: aei.aei.zaw@nhghealth.com.sg
Studienorte
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Singapore, Singapur, 308433
- Rekrutierung
- Tan Tock Seng Hospital
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Kontakt:
- Weida Chew, Masters
- Telefonnummer: 6563577897
- E-Mail: wei.da.chew@nhghealth.com.sg
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Kontakt:
- Aei Aei Zaw
- Telefonnummer: 6563573116
- E-Mail: aei.aei.zaw@nhghealth.com.sg
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Hauptermittler:
- Weida Chew
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Singapore, Singapur
- Rekrutierung
- National University of Singapore
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Kontakt:
- Xiaodan Cai
- Telefonnummer: 6567725073
- E-Mail: Xiaodan_Cai@nuhs.edu.sg
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Kontakt:
- Jonathan Wei Jie Lee
- E-Mail: jonathan_wj_lee@nuhs.edu.sg
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Hauptermittler:
- Jonathan Wei Jie Lee
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Singapore, Singapur
- Noch keine Rekrutierung
- Changi General Hospital
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Kontakt:
- Clinical Research Coordinator
- Telefonnummer: 6569365716
- E-Mail: ctru@cgh.com.sg
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Kontakt:
- Research Office Manager
- E-Mail: ctru@cgh.com.sg
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Hauptermittler:
- Tiing Leong Ang, Phd
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
Adult (40 - 80 years) Undergoing colonoscopy for screening, surveillance, or diagnostic indications. Complete colonoscopy with satisfactory Boston Bowel Prep Scale of 6 or higher. Provide informed consent to participate in the study
Exclusion Criteria:
Personal or family history of colorectal cancer Personal or family history of colonic polyposis syndromes Personal or family history of inflammatory bowel disease Prior colorectal surgery Contraindications to colonoscopy (intestinal obstruction, medical conditions that will make the risk of colonoscopy too high) Contraindications to polypectomy (ongoing anticoagulation / double antiplatelet therapy that cannot be stopped for the colonoscopy) Inability to give consent Incomplete colonoscopy/ Unable to retrieve specimen for pathology Poor bowel preparation (Boston Bowel Prep Scale <6) Pregnant Women
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: AI-assisted colonoscopy
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A real-time Computer Aided Detection (CADe) system can help improve the detection of SSL versus a conventional colonoscopy (CC) using white light examination(WLE).
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Kein Eingriff: Conventional Colonoscopy
Conventional Colonoscopy using white light
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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SSL per colonoscopy (SPC) using White Light Endoscopy alone vs enhancement by CADe system.
Zeitfenster: up to a year
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up to a year
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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1) Adenoma per colonoscopy (APC) using White Light Endoscopy alone vs enhancement by CADe system. 2) Polyp per colonoscopy (PPC) using White Light Endoscopy alone vs enhancement by CADe system. 3) Difference in the SPC, APC, PPC for each proceduralist
Zeitfenster: up to a year
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up to a year
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Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Joseph JY Sung, PHD, Nanyang Technological University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 1.Meester RGS, van Herk M, Lansdorp-Vogelaar I, et al. Prevalence and clinical features of sessile serrated polyps: a systematic review. Gastroenterology 2020;159:105-118.e25 2.Lui, R. N. et al. Prevalence and risk factors for sessile serrated lesions in an average risk colorectal cancer screening population. J. Gastroenterol. Hepatol. 36, 1656-1662 (2021) 3.Sekiguchi M, Matsuda T Prevalence of serrated lesions, risk factors, and their association with synchronous advanced colorectal neoplasia in asymptomatic screened individuals. J Gastroenterol Hepatol. 2020 Nov;35(11):1938-1944 doi: 10.1111/jgh.15116. Epub 2020 Jun 10 4.Sung JJY, Chiu HM Third Asia-Pacific consensus recommendations on colorectal cancer screening and postpolypectomy surveillance. Gut. 2022 Nov;71(11):2152-2166. doi: 10.1136/gutjnl-2022-327377. Epub 2022 Aug 24 5.Song M, Emilsson L, Bozorg SR, et al. Risk of colorectal cancer incidence and mortality after polypectomy: a Swedish recordlinkage study. Lancet Gastroenterol Hepatol 2020;5:537-547. 6.Gao Q, Tsoi KK, Hirai HW, et al. Serrated polyps and the risk of synchronous colorectal advanced neoplasia: a systematic review and meta-analysis. Am J Gastroenterol. 2015; 110: 501-9. 7.He X, Hang D, Wu K, et al. Long-term Risk of Colorectal Cancer After Removal of Conventional Adenomas and Serrated Polyps. Gastroenterology. 2020; 158: 852-61. 8.Ng SC, Sung JJ. Association between serrated polyps and the risk of synchronous advanced colorectal neoplasia in average-risk individuals. Aliment Pharmacol Ther. 2015 Jan;41(1):108-15. doi: 10.1111/apt.13003. Epub 2014 Oct 22. PMID: 25339583. 9.David E F W M van Toledo et al, Serrated polyp detection and risk of interval post-colonoscopy colorectal cancer: a population-based study, The Lancet Gastroenterology & Hepatology, Volume 7, Issue 8, 2022, Pages 747-754 10.Repici A, Hassan C. Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. Gastroenterology. 2020 Aug;159(2)
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2025-1940
Plan für individuelle Teilnehmerdaten (IPD)
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