METRIC (MREnterography or ulTRasound in Crohn’s disease): a study protocol for a multicentre, non-randomised, single-arm, prospective comparison study of magnetic resonance enterography and small bowel ultrasound compared to a reference standard in those aged 16 and over

BMC Gastroenterology

Study Protocol

Steve Halligan¹  Stuart Taylor¹  Shonit Punwani¹  Gauraang Bhatnagar¹  Damian Tolan²  Sara McCartney³  Stuart Bloom³  Manuel Rodriguez-Justo⁴  Alastair Windsor⁵  John Hamlin⁶  Charles Murray⁷  Ailsa Hart⁸  Steve Morris⁹  Peter Wylie^1,10  Arun Gupta^1,11  Ian Zealley^1,12  Andrew Slater^1,13  Antony Higginson^1,14  Susan Mallett^1,15  Ilan Jacobs^1,16  Simon Travis^1,17  Nicola Muirhead^1,18 

[1] Center for Medical Imaging, University College London, 250 Euston Rd, NW1 2PG, London, UK;Clinical Radiology, Leeds Teaching Hospitals NHS Trust, St James’s University Hospital, Beckett Street, Leeds, UK;Department of Gastroenterology, University College London Hospital, 235 Euston Road, London, UK;Department of Gastrointestinal Pathology, University College London Hospital, 235 Euston Road, London, UK;Department of Surgery, University College London Hospital, 235 Euston Road, London, UK;Gastroenterology, Leeds Teaching Hospitals NHS Trust, St James’s University Hospital, Beckett Street, Leeds, UK;Gastroenterology, Royal Free Hospital, Pond Street, London, UK;Gastroenterology, St Marks Hospital, Harrow Road, London, UK;Health Economics, UCL Research Department of Epidemiology and Public Health, University College London, 1-19 Torrington Place, London, UK;Imaging, Royal Free Hospital, Pond Street, London, UK;Intestinal Imaging, St Marks Hospital, Harrow Road, London, UK;Medical Imaging, Ninewells Hospital, Dundee, UK;Medical Imaging, Oxford University Hospitals NHS Trust, OX3 9DU, Oxford, UK;Medical Imaging, Queen Alexandra Hospital, Southwick Hill Road, Cosham, UK;Medical Statistics, Department of Primary Health Care Sciences, University of Oxford, 2nd Floor Offices, 23-38 Hythe Bridge Street, Oxford, UK;Public representative, Patient forum, National Association of Crohn’s and colitis, c/oUCL Partners CTU, Maple House, 149 Tottenham Court Rd, London, UK;Translational Gastroenterology Unit, Oxford University Hospitals NHS Trust, OX3 9DU, Oxford, UK;UCL Clinical Trials Unit, UCL Gower Street, London, UK;

关键词: Crohn’s disease;    Inflammatory bowel disease;    MRE;    USS;    Consensus panel;   

DOI  :  10.1186/1471-230X-14-142

 received in 2014-06-30, accepted in 2014-07-01,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundCrohn’s disease (CD) is a lifelong, relapsing and remitting inflammatory condition of the intestine. Medical imaging is crucial for diagnosis, phenotyping, activity assessment and detecting complications. Diverse small bowel imaging tests are available but a standard algorithm for deployment is lacking. Many hospitals employ tests that impart ionising radiation, of particular concern to this young patient population. Magnetic resonance enterography (MRE) and small bowel ultrasound (USS) are attractive options, as they do not use ionising radiation. However, their comparative diagnostic accuracy has not been compared in large head to head trials. METRIC aims to compare the diagnostic efficacy, therapeutic impact and cost effectiveness of MRE and USS in newly diagnosed and relapsing CD.MethodsMETRIC (ISRCTN03982913) is a multicentre, non-randomised, single-arm, prospective comparison study. Two patient cohorts will be recruited; those newly diagnosed with CD, and those with suspected relapse. Both will undergo MRE and USS in addition to other imaging tests performed as part of clinical care. Strict blinding protocols will be enforced for those interpreting MRE and USS. The Harvey Bradshaw index, C-reactive protein and faecal calprotectin will be collected at recruitment and 3 months, and patient experience will be assessed via questionnaires. A multidisciplinary consensus panel will assess all available clinical and imaging data up to 6 months after recruitment of each patient and will define the standard of reference for the presence, localisation and activity of disease against which the diagnostic accuracy of MRE and USS will be judged. Diagnostic impact of MRE and USS will be evaluated and cost effectiveness will be assessed. The primary outcome measure is the difference in per patient sensitivity between MRE and USS for the correct identification and localisation of small bowel CD.DiscussionThe trial is open at 5 centres with 46 patients recruited. We highlight the importance of stringent blinding protocols in order to delineate the true diagnostic accuracy of both imaging tests and discuss the difficulties of diagnostic accuracy studies in the absence of a single standard of reference, describing our approach utilising a consensus panel whilst minimising incorporation bias.Trial registrationMETRIC - ISRCTN03982913 – 05.11.13.

【 授权许可】

CC BY   
© Taylor et al.; licensee BioMed Central Ltd. 2014