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临床试验/NCT03096379
NCT03096379已完成不适用

Differentiating Gut Tuberculosis and Crohn's Disease Via Magnetic Resonance Enterography

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Small / large bowel transmural enhancement

研究概览

简要总结

It is clinically challenging to differentiate Crohn's disease from gut tuberculosis especially in regions endemic of tuberculosis infection. The investigators plan to perform magnetic resonance enterography (MRE) who presented to our hospital in Shenzhen, China for new onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy. MRE findings will be independently interpreted by two radiologistsThe role of MRE in distinguishing gut tuberculosis from Crohn's disease will be determined.

详细描述

The clinical presentation of gut tuberculosis and Crohn's disease is very similar. In areas endemic of tuberculosis infection, differentiating the two diseases remains difficult. Both disease entities can have similar clinical, endoscopic and histological findings. Yet, wrongly diagnosing gut tuberculosis as Crohn's disease can potentially result in disastrous outcomes, especially when anti-tumor necrosis factor therapy, an important therapeutic option for Crohn's disease, can result in fulminant reactivation of tuberculosis.

Magnetic resonance enterography (MRE) is emerging as a effective imaging modality in evaluating the disease status of Crohn's disease. MRE, unlike computed tomography, emits no radiation, and is suitable for repeated serial imaging in younger-age populations. Ulcerations, strictures, transmural enhancement and mesenteric combing of the small bowel can be clearly demonstrated via MRE in Crohn's disease. Yet, the utilization of MRE in diagnosing gut tuberculosis remains largely unexplored. Whether MRE can be used to differentiate gut tuberculosis from Crohn's disease remains unknown.

The investigators plan to consecutively recruit 150 patients presenting to our hospital in Shenzhen, China, for new onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy.All recruited participants will undergo MRE, to be performed on a 1.5 Tesla scanner (Magnetom Avanto, Siemens Healthcare, Erlangen, Germany). MRE findings will be independently interpreted by two radiologists with special expertise in abdominal MR imaging and blinded to the patients' clinical data. The relationship between radiological patterns and clinical, endoscopic and histological findings will be analyzed. The role of MRE in distinguishing gut tuberculosis from Crohn's disease will be determined.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • New-onset lower gastrointestinal symptoms of less than 3 months
  • Ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy.
  • No prior tuberculosis treatment
  • No prior immunomodulatory or anti-tumor necrosis factor treatment

排除标准

  • Stage 4 or 5 chronic kidney disease, i.e. a glomerular filtration rate of <=30 ml/min.
  • Contraindications to magnetic resonance imaging, including the installation of metallic devices or implants in-situ (e.g. pacemakers)
  • Prior intestinal resection
  • Known concomitant chronic small / large bowel disease, including ulcerative colitis, eosinophilic gastroenteritis, NSAID-related enterography etc.

结局指标

主要结局

Small / large bowel transmural enhancement

时间窗: During procedure

Via magnetic resonance enterography independently interpreted by two radiologist with expertise

次要结局

  • Vascular engorgement(During procedure)
  • Skip lesions in small / large bowel(During procedure)
  • Mesenteric combing(During procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wai-Kay Seto

Clinical Associate Professor

The University of Hong Kong

研究点 (1)

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