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Comparing standard colonoscopy versus colonoscopy associated to a special technique of virtual chromoendoscopy named Fuji Intelligent Colour Enhancement (FICE) in the endoscopic surveillance of ulcerative colitis for neoplasia

ABSTRACT: 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

DISEASE(S): Oral And Gastrointestinal-other Diseases Of The Mouth, Teeth, Oesophagus, Digestive System Including Liver And Colon,Ulcerative Colitis,Oral And Gastrointestinal-inflammatory Bowel Disease

PROVIDER: 2468104 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:The aim of the study is to determine if Serrated Poliposis Syndrome (SPS) patients with SPS criteria 2, with clearing phase achieved and without any advanced lesion or less than 5 relevant lesions at last colonoscopy have the same advanced neoplasia incidence in the surveillance colonoscopy at 2 or 3 years. Patients selected for the study will be randomised in two groups for the surveillance: group 1, surveillance with colonoscopy in two years; group 2, surveillance with colonoscopy in three years. Randomization will be done at the database program (RedCAP). All colonoscopies will be performed with high definition (HD) system and it will be the choice of the endoscopist whether to use chromoendoscopy with indigo carmine o virtual chromoendoscopy. Protocol bowel preparation will be recommended by each centre. Sedation will be prescribed and decided by the endoscopist during the examination. Data from all the resected and visualized lesions during the colonoscopy will be collected on the database. A pathologist familiarized with serrated lesions will be in charge of the sample analysis. Serrated lesions will be classified attending de WHO criteria for serrated lesions. The investigators define "advanced adenoma" as adenomas ≥10 mm with villous histology and/or with high grade of dysplasia (HGD). The investigators define "advanced SL" as any SL ≥10mm and any SL with dysplasia. The investigators also define "advanced neoplasia" as any colorectal cancer (CRC), any advanced adenoma or advanced Serrated Lesions (SL). Quality of bowel cleansing will be graded by each endoscopist following the Boston Bowel Preparation Scale. This scale evaluates each segment (ascending colon, transverse colon and descending colon) of the following form: 0 = segment of colon whose mucosa cannot be seen due to the existence of solid stools that cannot be eliminated; 1 = mucosa portion of a colonic segment that can be seen, but other areas of the colonic segment are not seen, either due to the presence of dirt, feces or opaque liquid; 2 = existence of small amount of dirt, small fragments of stool and / or opaque liquid, but the mucosa of the colonic segment can be seen well; 3 = all the mucosa of the colonic segment can be seen well without residual dirt, small traces of stool or opaque liquid. Patients with inadequate preparation (when in any segment the score is 0 or 1, or the total score is less than 6) will be excluded from the study. During colonoscopy all complications as post-polypectomy bleeding, perforation or cardio-respiratory events will be registered. Those complications will be considered if surgery or hospital admission is required.

Dataset Information

Comparing standard colonoscopy versus colonoscopy associated to a special technique of virtual chromoendoscopy named Fuji Intelligent Colour Enhancement (FICE) in the endoscopic surveillance of ulcerative colitis for neoplasia

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