Diagnostic accuracy for the extent and activity of newly diagnosed and relapsed Crohn's disease: a multicentre prospective comparison of magnetic resonance enterography and small bowel ultrasound compared to a reference standard

niversity College London (UK)0 个研究点目标入组 335 人开始时间: 2013年11月5日最近更新: 2023年8月21日

适应症

试验速览

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25110044 protocol 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29914843 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31432777 results (added 23/08/2019) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37526665/ Post hoc analysis comparing ultrasound with MRI and histology (added 02/08/2023)

•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 (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

发起方

niversity College London (UK)