Crohn's disease Digestive System Crohn disease, unspecified
Conditions
Interventions
Diagnostic accuracy study - comparison of magnetic resonance enterography and small bowel ultrasound compared to a reference standard.
No control and no randomisation is involved.
After consent, pa
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria (new diagnosis) 1. Patients (= 16 years) undergoing or having undergone colonoscopy and either: newly diagnosed (within 3 months) with Crohn's disease based on endoscopic, histological, clinical and radiological findings, OR highly suspected of Crohn's disease based on characteristic endoscopic, imaging and/or histological features but pending final diagnosis. 2. Patient must be able to provide informed consent. Patient inclusion criteria (suspected relapse) 1. Patients (= 16 years) with a known diagnosis of Crohn's disease with high clinical suspicion of luminal relapse indicating radiological investigation. High clinical suspicion defined as objective markers of inflammatory activity (raised C Reactive Protein >8 mg/l OR raised calprotectin >100), OR symptoms suggestive of luminal stenosis (including obstructive symptoms such as colicky abdominal pain, vomiting) OR abnormal endoscopy suggesting relapse. 2. Patient must be able to provide informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria (all patients) 1. Any psychiatric or other disorder likely to impact on informed consent 2. Evidence of severe or uncontrolled systemic disease which make it undesirable for the patient to participate in the study 3. Pregnancy 4. Contraindications to Magnetic Resonance Imaging (e.g. cardiac pacemaker, severe claustrophobia, inability to lie flat). Patient exclusion criteria (new diagnosis) 1. Final diagnosis other than Crohn's disease 2. Patients undergoing surgical resection prior to colonoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in per patient sensitivity of MRE and US as diagnostic tests for the correct identification and localisation of small bowel Crohn's disease, compared to a consensus reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| As well as the difference in specificity of Magnetic Resonance Imaging and Ultrasound for correct identification and localisation of small bowel Crohn's disease per patient, the information provided by this study will also be used to look at Crohn's disease in the colon. There will also be separate analysis of the results of the two groups of patients: those who are newly diagnosed and those who are suffering a relapse. This will include the sensitivity and specificity from patient to patient and between the two groups. Patients in the two groups who have received colonoscopic investigation will have their results from the MRI and US scan compared with the colonoscopy results at various sections throughout the small bowel. A number of validated and non-validated but previously used questionnaires and case report forms (CRFs) will be used to determine the following outcomes. Clinical expertise and a consensus panel questionnaire after 6 months of patient follow-up will be used to determine the standard of reference for diagnostic accuracy against which the clinical end points will be defined. 1. How Magnetic Resonance Imaging and Ultrasound compare to each other, and to conventional imaging methods, in providing doctors with confidence in the accuracy of the diagnosis they provide patients, and how the diagnosis influences doctors' management of patients. Clinical expertise and a consensus panel questionnaire after 6 months follow-up will define the standard of reference for diagnostic accuracy. A validated diagnostic and therapeutic impact proforma will be applied to model the effect of MRI, USS and conventional tests on patient management during the 6 months follow-up. 2. Whether there is a difference in cost of Magnetic Resonance Imaging and Ultrasound compared to each other, and to conventional imaging methods, and how important the difference in cost is when the compared accuracy of the techniques is taken into account. Clinical expertise and consensus panel | — |
Countries
England, United Kingdom
Outcome results
None listed