An artificial intelligence-assisted system versus white light endoscopy alone for adenoma detection in individuals with Lynch syndrome (TIMELY): an international, multicentre, randomised controlled trial.

Autor:	Ortiz O; Hospital Clinic Barcelona, Gastroenterology Department, Barcelona, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Institut d'Investigacions Biomédiques August Pi i Sunyer, Barcelona, Spain., Daca-Alvarez M; Hospital Clinic Barcelona, Gastroenterology Department, Barcelona, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Institut d'Investigacions Biomédiques August Pi i Sunyer, Barcelona, Spain., Rivero-Sanchez L; Hospital Clinic Barcelona, Gastroenterology Department, Barcelona, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Institut d'Investigacions Biomédiques August Pi i Sunyer, Barcelona, Spain., Gimeno-Garcia AZ; Hospital Universitario de Canarias, Digestive System Service, Santa Cruz de Tenerife, Spain., Carrillo-Palau M; Hospital Universitario de Canarias, Digestive System Service, Santa Cruz de Tenerife, Spain., Alvarez V; Complejo Hospitalario de Pontevedra, Department of Gastroenterology, Pontevedra, Spain., Ledo-Rodriguez A; Complejo Hospitalario de Pontevedra, Department of Gastroenterology, Pontevedra, Spain., Ricciardiello L; IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy; Gastroenterology, Hepatology, and Nutrition, University of Texas at MD Anderson Cancer Center, Houston, TX, USA., Pierantoni C; IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy., Hüneburg R; Department of Internal Medicine I and National Center for Hereditary Tumor Syndromes, University Hospital Bonn, Bonn, Germany; European Reference Network for Genetic Tumor Risk Syndromes (ERN Genturis), Bonn, Germany., Nattermann J; Department of Internal Medicine I and National Center for Hereditary Tumor Syndromes, University Hospital Bonn, Bonn, Germany; European Reference Network for Genetic Tumor Risk Syndromes (ERN Genturis), Bonn, Germany., Bisschops R; Gastroenterology Department, University Hospital Leuven, Leuven, Belgium., Tejpar S; Gastroenterology Department, University Hospital Leuven, Leuven, Belgium., Huerta A; Hospital Galdakao-Usansolo, Department of Gastroenterology, Galdakao, Spain., Riu Pons F; Gastroenterology Department, Hospital del Mar Research Institute, Barcelona, Spain., Alvarez-Urturi C; Gastroenterology Department, Hospital del Mar Research Institute, Barcelona, Spain., López-Vicente J; Hospital Universitario de Móstoles, Digestive System Service, Móstoles, Spain., Repici A; Gastroenterology Department, IRCCS Humanitas Research Hospital, Milan, Italy., Hassan C; Gastroenterology Department, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy., Cid L; Hospital Alvaro Cunqueiro, Galicia, Spain; Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain., Cavestro GM; Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy., Romero-Mascarell C; Hospital de la Santa Creu i Sant Pau, Gastroenterology Unit, Barcelona, Spain., Gordillo J; Hospital de la Santa Creu i Sant Pau, Gastroenterology Unit, Barcelona, Spain., Puig I; Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IRIS-CC), Vic, Spain; Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Manresa, Spain; Facultat de Medicina, Universitat de Vic-Central de Cataluña (UVIC-UCC), Vic, Spain., Herraiz M; University of Navarra Clinic-IdiSNA, Gastroenterology Department, Pamplona, Spain., Betes M; University of Navarra Clinic-IdiSNA, Gastroenterology Department, Pamplona, Spain., Herrero J; Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Biomédica Galicia Sur, CIBERehd, Ourense, Spain., Jover R; Hospital Universitario de Alicante, Pais Valencia, Spain., Balaguer F; Hospital Clinic Barcelona, Gastroenterology Department, Barcelona, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Institut d'Investigacions Biomédiques August Pi i Sunyer, Barcelona, Spain; University of Barcelona, Barcelona, Spain., Pellisé M; Hospital Clinic Barcelona, Gastroenterology Department, Barcelona, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBEREHD), Institut d'Investigacions Biomédiques August Pi i Sunyer, Barcelona, Spain; University of Barcelona, Barcelona, Spain. Electronic address: mpellise@clinic.cat.
Jazyk:	angličtina
Zdroj:	The lancet. Gastroenterology & hepatology [Lancet Gastroenterol Hepatol] 2024 Sep; Vol. 9 (9), pp. 802-810. Date of Electronic Publication: 2024 Jul 19.
DOI:	10.1016/S2468-1253(24)00187-0
Abstrakt:	Background: Computer-aided detection (CADe) systems for colonoscopy have been shown to increase small polyp detection during colonoscopy in the general population. People with Lynch syndrome represent an ideal target population for CADe-assisted colonoscopy because adenomas, the primary cancer precursor lesions, are characterised by their small size and higher likelihood of showing advanced histology. We aimed to evaluate the performance of CADe-assisted colonoscopy in detecting adenomas in individuals with Lynch syndrome. Methods: TIMELY was an international, multicentre, parallel, randomised controlled trial done in 11 academic centres and six community centres in Belgium, Germany, Italy, and Spain. We enrolled individuals aged 18 years or older with pathogenic or likely pathogenic MLH1, MSH2, MSH6, or EPCAM variants. Participants were consecutively randomly assigned (1:1) to either CADe (GI Genius) assisted white light endoscopy (WLE) or WLE alone. A centre-stratified randomisation sequence was generated through a computer-generated system with a separate randomisation list for each centre according to block-permuted randomisation (block size 26 patients per centre). Allocation was automatically provided by the online AEG-REDCap database. Participants were masked to the random assignment but endoscopists were not. The primary outcome was the mean number of adenomas per colonoscopy, calculated by dividing the total number of adenomas detected by the total number of colonoscopies and assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT04909671. Findings: Between Sept 13, 2021, and April 6, 2023, 456 participants were screened for eligibility, 430 of whom were randomly assigned to receive CADe-assisted colonoscopy (n=214) or WLE (n=216). 256 (60%) participants were female and 174 (40%) were male. In the intention-to-treat analysis, the mean number of adenomas per colonoscopy was 0·64 (SD 1·57) in the CADe group and 0·64 (1·17) in the WLE group (adjusted rate ratio 1·03 [95% CI 0·72-1·47); p=0·87). No adverse events were reported during the trial. Interpretation: In this multicentre international trial, CADe did not improve the detection of adenomas in individuals with Lynch syndrome. High-quality procedures and thorough inspection and exposure of the colonic mucosa remain the cornerstone in surveillance of Lynch syndrome. Funding: Spanish Gastroenterology Association, Spanish Society of Digestive Endoscopy, European Society of Gastrointestinal Endoscopy, Societat Catalana de Digestologia, Instituto Carlos III, Beca de la Marato de TV3 2020. Co-funded by the European Union. Competing Interests: Declaration of interests AL-R received payment or honoraria for lectures, presentations, speakers bureaus, or educational events from Boston Scientific, Fujifilm, NEC, and Olympus. AZG-G received grants from Fundación de la Sociedad Española de Endoscopia Digestiva and University Hospital of the Canary Islands. CH received a grant from AIRC under IG 2022 (ID 27843) project and consulting fees from Boston Scientific, Fujifilm, Olympus, and Odin. IP received consulting fees from Fujifilm and support for travels and attending meetings from Fujifilm and Casen. JN received grants or contracts from Deutsche Forschungsgemeinschaft (DFG), Deutsches Zentrum für Infektionsforschung (DZIF), Deutsche Krebshilfe, Hector-Stiftung, Bundesministerium für Bildung und Forschung (BMBF); and payment honoraria for lectures and presentations, travel, and attending meetings from Falk foundation. RB received research funding, speaker, and advisory fees from Medtronic; grants and contracts from Pentax, Digital Endoscopy, and Fujifilm; payment or honoraria for lectures and presentations from Medtronic, Pentax, and Fujifilm; receipt of equipment from Fujifilm and Pentax; and payment for expert testimony from Pentax. RB is also supported by a grant of Research Foundation Flanders. RH received grants or contracts from DFG, DZIF, Deutsche Krebshilfe, Hector-Stiftung, and BMBF; received payment for lectures and presentations from Falk Foundation and MSD Sharp&Dohme; and received equipment from Fujifilm. MP received speakers fees from Medtronic and advisory and speakers fees from Fujifilm and Olympus. FB received consultant fees from Olympus, Nouscom, Sysmex, and Norgine, and editorial fees from Elsevier. RJ received contracts from Medtronic through a research grant institution. All other authors declare no competing interests. (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)
Databáze:	MEDLINE
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