Dataset Information

Accuracy for Predicting Deep Submucosal Invasion

ABSTRACT: The main aim of this study is to determine whether the assessment of the invasive pattern based on NBI with dual focus/magnification or BLI with magnification ± chromoendoscopy (NBI+CE) for predicting deep invasion is significantly more accurate than the assessment based on white light endoscopy (WLE), carried out by trained endoscopists.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms,Colorectal Polyp

PROVIDER: 2290095 | 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

Accuracy for Predicting Deep Submucosal Invasion

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets