A Randomized Crossover Trial of Conventional vs Virtual Chromoendoscopy for Colitis Surveillance: Dysplasia Detection, Feasibility, and Patient Acceptability (CONVINCE)
Authors:
- 20 December 2018
- journal article
- research article
- Published by Oxford University Press (OUP) in Inflammatory Bowel Diseases
- Vol. 25 (6) , 1096-1106
Abstract
Chromoendoscopy (CE) is the recommended surveillance technique for colitis, but uptake has been limited and the literature provides scant information on patient experience (PE); imperative to adherence to surveillance programmes. Virtual CE (VCE) by Fujinon Intelligent Colour Enhancement digitally reconstructs mucosal images in real time, without the technical challenges of CE. We performed a multifaceted randomized crossover trial (RCT) to evaluate study feasibility and obtain preliminary comparative procedural and PE data. Patients were randomized to undergo either CE with indigo carmine or VCE as the first procedure. After 3–8 weeks, participants underwent colonoscopy with the second technique. Patient recruitment/retention, missed dysplasia, prediction of dysplasia, and contamination (memory/sampling of the first procedure) were recorded. PE was assessed by validated questionnaires, and pain was assessed using a visual analog scale (mm). Sixty patients were recruited, and 48 patients (first procedure: 23 VCE, 25 CE) completed the trial (retention 80%) with no episodes of contamination. Eleven dysplastic lesions were detected in n = 7/48 (14.5%). VCE missed 1 lesion, and CE missed 2 lesions in n = 2 (data of VCE vs CE, respectively, for dysplasia diagnostic accuracy: 93.94% [85.2%–98.32%] vs 76.9% [66.9%–98.2%]; examination time [minutes]: 14 +/- 4 vs 20 +/- 7 (95% confidence interval, 3.5 to 8; P < 0.001); pain (mm): 27.4 +/- 17.5 vs 34.7 +/- 18; patient preference: 67% [n = 31] vs 33% [n = 15] in n = 46; P < 0.001). This is the first RCT to include validated PE in a colitis surveillance program. VCE is safe, technically easier, quicker, and more comfortable test, with dysplasia detection at least as good as that of CE, overcoming many barriers to the wider adoption of CE. This trial may serve as a successful foundation for a a multicenter trial to confirm the value of VCE for colitis surveillance.Keywords
Funding Information
- National Institute of Health Research (PB-PG-0614-34040)
This publication has 34 references indexed in Scilit:
- Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practiceGastrointestinal Endoscopy, 2013
- Differentiating Small Polyp Histologies Using Real-Time Screening Colonoscopy With Fuji Intelligent Color EnhancementClinical Gastroenterology and Hepatology, 2011
- Colorectal cancer screening in patients with ulcerative and crohnʼs colitis with use of colonoscopy, chromoendoscopy and confocal endomicroscopyEuropean Journal of Gastroenterology & Hepatology, 2011
- Computerized virtual chromoendoscopy versus indigo carmine chromoendoscopy combined with magnification for diagnosis of small colorectal lesionsEuropean Journal of Gastroenterology & Hepatology, 2010
- Guidelines for colorectal cancer screening and surveillance in moderate and high risk groups (update from 2002)Gut, 2010
- Computed virtual chromoendoscopy versus standard colonoscopy with targeted indigocarmine chromoscopy: a randomised multicentre trialGut, 2008
- Chromoscopy-Guided Endomicroscopy Increases the Diagnostic Yield of Intraepithelial Neoplasia in Ulcerative ColitisGastroenterology, 2007
- Indigo Carmine-Assisted High-Magnification Chromoscopic Colonoscopy for the Detection and Characterisation of Intraepithelial Neoplasia in Ulcerative Colitis: A Prospective EvaluationEndoscopy, 2005
- Pancolonic indigo carmine dye spraying for the detection of dysplasia in ulcerative colitisGut, 2004
- Inter-observer variation between general and specialist gastrointestinal pathologists when grading dysplasia in ulcerative colitisThe Journal of Pathology, 2001