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

Ian Zealley⁵  Peter Wylie⁶  Alastair Windsor^1,18  Damian Tolan²  Simon Travis^1,13  Andrew Slater^1,12  Manuel Rodriguez-Justo³  Shonit Punwani⁹  Charles Murray¹  Nicola Muirhead^1,16  Steve Morris^1,14  Sara McCartney⁴  Ilan Jacobs⁸  Antony Higginson^1,10  Ailsa Hart^1,15  John Hamlin⁷  Steve Halligan⁹  Arun Gupta^1,17  Stuart Bloom⁴  Gauraang Bhatnagar⁹  Susan Mallett^1,11  Stuart Taylor⁹ 

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

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

Others  :  1121848
DOI  :  10.1186/1471-230X-14-142

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

【 摘 要 】

Background

Crohn’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.

Methods

METRIC (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.

Discussion

The 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 registration

METRIC - ISRCTN03982913 – 05.11.13.

【 授权许可】

   
2014 Taylor et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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