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USAGE OF ARITIFICIAL INTELLIGENCE IN AIDING WITH COLONIC SESSILE SERRATED LESIONS DETECTION AND DIAGNOSIS (AI-SSL) (AI-SSLD)

10 juni 2026 bijgewerkt door: Chew Wei Da, National Healthcare Group, Singapore

USAGE OF ARITIFICIAL INTELLIGENCE IN AIDING WITH COLONIC SESSILE SERRATED LESIONS DETECTION AND DIAGNOSIS (AI-SSLD)

The aim of this study is to is to evaluate if a real-time Computer Aided Detection (CADe) system can help improve the detection of SSL(sessile serrated lesions) versus a conventional colonoscopy (CC) using white light examination(WLE).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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%.

Studietype

Ingrijpend

Inschrijving (Geschat)

628

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Singapore
      • Singapore, Singapore, 308433
      • Singapore, Singapore
      • Singapore, Singapore
        • Nog niet aan het werven
        • Changi General Hospital
        • Contact:
          • Clinical Research Coordinator
          • Telefoonnummer: 6569365716
          • E-mail: ctru@cgh.com.sg
        • Contact:
        • Hoofdonderzoeker:
          • Tiing Leong Ang, Phd

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Screening
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: AI-assisted colonoscopy
Apparaat: usage of CADe system
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).
Geen tussenkomst: Conventional Colonoscopy
Conventional Colonoscopy using white light

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
SSL per colonoscopy (SPC) using White Light Endoscopy alone vs enhancement by CADe system.
Tijdsspanne: up to a year
up to a year

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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
Tijdsspanne: up to a year
up to a year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Healthcare Group, Singapore

Medewerkers

Changi General Hospital
National University Health System, Singapore

Onderzoekers

  • Studie stoel: Joseph JY Sung, PHD, Nanyang Technological University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • 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)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 mei 2026

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

3 mei 2027

Studieregistratiedata

Eerst ingediend

10 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2025-1940

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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