Dataset Information

Real-time use of artificial intelligence (CAD EYE) in the colorectal cancer surveillance of Lynch syndrome patients (CADLYII) – an international multicenter trial

ABSTRACT: Interventions: Group 1: Standard high-definition white-light endoscopy (HD-WLE) in Lynch syndrome patients during colorectal cancer surveillance Group 2: Standard high-definition white-light endoscopy (HD-WLE) and additional real-time use of artificial intelligence (CADEYE Fujifilm) in Lynch syndrome patients during colorectal cancer surveillance Primary outcome(s): Comparison of the adenoma detection rate (ADR) during high-definition white-light endoscopy (HD-WLE) with versus without real-time automated detection (CAD EYE Fujifilm) Study Design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: diagnostic

DISEASE(S): Family History Of Malignant Neoplasm Of Digestive Organs

PROVIDER: 72537 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Similar Datasets

Project description:Interventions: This was a prospective, parallel trial, in which consecutive patients with long-lasting ulcerative colitis who were scheduled for surveillance colonoscopy at our centre are submitted to a withdrawal colonoscopy with standard with-light endoscopy or virtual chromoendoscopy with FICE. The intervention includes full colonoscopy with one of two type of colonoscopes which differred about the technology of image visualisation in vivo: standard resolution white light endoscopy (WLE) versus high-definition virtual chromoendoscopy with Fuji Intelligent Colour Enhancement (FICE). The endoscopic procedures are performed in a single day by endoscopists with more than 10 years of experience in IBD endoscopy and with experience in chromoendoscopy. The day before the procedure, the patients receive a bowel preparation. Bowel preparation is performed with a no fibers diet 5 days before the exam, a liquid diet the day before the procedure and 4 liters of liquids with macrogol the day before the examination. Before starting the procedure, the patients receive a sedation with intravenous midazolam (1-5 mg) and/or meperidine (25-50 mg) according to our institutional guideline (standard dose: midazolam 5 mg ev plus meperidine 50 mg; lower dosages in cases of cardiopulmonar comorbidities). In the WLE arm, standard white light colonoscopy is performed using the Olympus CV-180 Evis Exera II system (Olympus Corp., Tokyo, Japan) for both intubation and extubation. In the FICE arm, virtual chromoendoscopy is activated during extubation from the caecum and performed with a high-definition magnification colonoscope (Fujinon EG-590ZW, Fujinon Corp, Saitama, Japan), equipped with the EPX4400 processor. The patients enrolled are prospectively allocated to one arm or to the other one, according to the availability of the endoscopic instrument, a colonoscope with WLE or FICE, this latter being only one in our centre and therefore being available only after its washing an Primary outcome(s): To analyze the rate of true positive lesions in the FICE arm compared with the WLE arm, defined as the number of lesions suspected for neoplasia according to the FICE or WLE criteria and confirmed as neoplastic by histology.[after histological evaluation (using histology as reference test for both arms) performed within 72 hours of colonoscopy];To analyze the rate of false negative lesions in the FICE arm compared with the WLE arm, defined as the number of lesions not suspected for neoplasia according to the FICE or WLE criteria but which were diagnosed as neoplastic by histology.[after histological evaluation (using histology as reference test for both arms) performed within 72 hours of colonoscopy] Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

Dataset Information

Real-time use of artificial intelligence (CAD EYE) in the colorectal cancer surveillance of Lynch syndrome patients (CADLYII) – an international multicenter trial

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets