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Completed

NCT Number: NCT03096379

MRI Differentiating Gut TB and Crohn's

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

Enterography performed via magnetic resonance imaging

Primary outcomes

  1. Small / large bowel transmural enhancement

    Time frame: During procedure

    Via magnetic resonance enterography independently interpreted by two radiologist with expertise

Secondary outcomes

  1. Skip lesions in small / large bowel

    Time frame: During procedure

    Via magnetic resonance enterography independently interpreted by two radiologist with expertise

  2. Vascular engorgement

    Time frame: During procedure

    Via magnetic resonance enterography independently interpreted by two radiologist with expertise

  3. Mesenteric combing

    Time frame: During procedure

    Via magnetic resonance enterography independently interpreted by two radiologist with expertise

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • The University of Hong Kong-Shenzhen Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Mar 30, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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