This international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). The diagnostic performance of the new score in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes will be evaluated. The study also aims to adapt current artificial intelligence (AI) algorithms for enhanced endoscopic techniques to improve standardization in UC disease assessment and outcome prediction.
This is a multicentre prospective international study. This study aims at developing a new simple endoscopic score using white light endoscopy - high definition (WLE-HD), Texture and colour enhancement imaging (TXI), red dichromatic imaging (RDI) and narrow-band imaging (NBI) modes, focusing on vascular features to distinguish between quiescent versus patchy mild Ulcerative Colitis. It will evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes. Finally, it also aims to develop and adapt existing artificial intelligence (AI) algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes. The study will be divided in several phases: * In the first phase, the score will be developed on the first 30 consecutive virtual electronic chromoendoscopy (VCE) videos (using TXI-RDI and NBI) of UC patients, with different grade of disease activity. Experts in inflammatory bowel disease (IBD) endoscopy will review images and videos from recruited patients to define the endoscopic mucosal and vascular features of the new score. These will be used for a stepwise discussion. A round table discussion using modified Delphi method will be conducted by experts worldwide to ensure equal participation and identify the best component descriptors of endoscopic vascular healing. The components that will achieve 100% consensus will be selected, and the most important endoscopy predictive variables will be confirmed by using a machine learning technique. Finally, a new endoscopic score will be generated. This should be reproducible, valid and responsive. * In the second phase, the new endoscopic scoring system will be validated in a large cohort of UC patients, focusing on patients with quiescent disease versus patchy mild colitis. Diagnostic accuracy, interobserver agreement and ability to predict clinical outcome according to the new endoscopic score focused on vascular features assessed with VCE will be evaluated * In the third phase, the reproducibility of the new endoscopic scoring system will be evaluated among gastroenterologists with different levels of experience through a short survey and a computerised training module. * In the fourth phase, new and existing AI algorithms will be developed and adapted to these endoscopic videos and histological images to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcome in UC.
Study Type
OBSERVATIONAL
Enrollment
300
Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI.
During colonoscopy, at least 2 biopsies from each segment will be taken as standard of care to assess inflammation in UC
Blood samples will be taken for standard of care by appropriately trained members of the clinical research team. The results of the standard of care blood will be used in the research.
The stool sample will be sent to the laboratory for Faecal Calprotectin (FCP) as a marker of disease activity.
Patients will be followed-up at 6 and 12 months after index endoscopy. Patients will be evaluated in clinic or by telephone call and the disease will be reassessed. Partial Mayo Score (PMS) and occurrence of clinical outcomes will be evaluated.
University of Leuven
Leuven, Belgium
NOT_YET_RECRUITINGKlinikum Luneburg
Lüneburg, Germany
NOT_YET_RECRUITINGUniversity College Cork
Cork, Co Cork, Ireland
RECRUITINGOspedale S. Maria del Prato
Feltre, Belluno, Italy
NOT_YET_RECRUITINGUniversity of Bari
Bari, Italy
NOT_YET_RECRUITINGIstituto Clinico Humanitas
Milan, Italy
NOT_YET_RECRUITINGUniversity Vita-Salute San Raffaele
Milan, Italy
NOT_YET_RECRUITINGUniversity of Naples
Naples, Italy
RECRUITINGUniversity of Pavia
Pavia, Italy
NOT_YET_RECRUITINGShowa University
Tokyo, Japan
NOT_YET_RECRUITING...and 1 more locations
Diagnostic performance of the new scoring system
To evaluate the diagnostic performance of the new score in evaluating endoscopic and histological activity
Time frame: 6 months
Correlation with existing score
To evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes
Time frame: 2 years
AI development
Develop and adapt existing AI algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes in UC
Time frame: 2 years
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