Centre for Medical Imaging, University College London, London, UK.
Department of Gastroenterology, University College London Hospitals NHS Foundation Trust, London, UK.
BMJ Open. 2022 Oct 3;12(10):e067265. doi: 10.1136/bmjopen-2022-067265.
Crohn's disease (CD) is characterised by discontinuous, relapsing enteric inflammation. Instituting advanced therapies at an early stage to suppress inflammation aims to prevent future complications such as stricturing or penetrating disease, and subsequent surgical resection. Therapeutics are effective but associated with certain side-effects and relatively expensive. There is therefore an urgent need for robust methods to predict which newly diagnosed patients will develop disabling disease, to identify patients who are most likely to benefit from early, advanced therapies. We aim to determine if magnetic resonance enterography (MRE) features at diagnosis improve prediction of disabling CD within 5 years of diagnosis.
We describe the protocol for a multicentre, non-randomised, single-arm, prospective study of adult patients with newly diagnosed CD. We will use patients already recruited to the METRIC study and extend their clinical follow-up, as well as a separate group of newly diagnosed patients who were not part of the METRIC trial (MRE within 3 months of diagnosis), to ensure an adequate sample size. Follow-up will extend for at least 4 years. The primary outcome is to evaluate the comparative predictive ability of prognostic models incorporating MRE severity scores (Magnetic resonance Enterography Global Score (MEGS), simplified MAgnetic Resonance Index of Activity (sMaRIA) and Lémann Index) versus models using standard characteristics alone to predict disabling CD (modified Beaugerie definition) within 5 years of new diagnosis.
This study protocol achieved National Health Service Research Ethics Committee (NHS REC), London-Hampstead Research Ethics Committee approval (IRAS 217422). Our findings will be disseminated via conference presentations and peer-reviewed publications.
ISRCTN76899103.
克罗恩病（CD）的特征是间断性、复发性肠道炎症。在早期采用先进的治疗方法抑制炎症，旨在预防未来的并发症，如狭窄或穿透性疾病，以及随后的手术切除。治疗方法是有效的，但也存在一定的副作用和相对较高的费用。因此，迫切需要强有力的方法来预测哪些新诊断的患者会发展为致残性疾病，以确定最有可能从早期、先进治疗中受益的患者。我们旨在确定诊断时的磁共振肠造影（MRE）特征是否能提高对诊断后 5 年内致残性 CD 的预测。
我们描述了一项多中心、非随机、单臂、前瞻性研究成人新诊断 CD 患者的方案。我们将使用已经招募到 METRIC 研究中的患者，并扩展他们的临床随访，以及一组新诊断的患者（METRIC 试验以外的患者，即在诊断后 3 个月内进行 MRE），以确保有足够的样本量。随访时间至少为 4 年。主要结局是评估纳入 MRE 严重程度评分（磁共振肠造影全局评分（MEGS）、简化磁共振活动指数（sMaRIA）和 Lémann 指数）的预后模型与仅使用标准特征的模型相比，预测新诊断后 5 年内致残性 CD（改良 Beaugerie 定义）的比较预测能力。
本研究方案获得了国民保健制度研究伦理委员会（NHS REC）、伦敦-汉普斯特德研究伦理委员会（IRAS 217422）的批准。我们的研究结果将通过会议报告和同行评审出版物进行传播。
ISRCTN76899103。
