MRI Differentiating Gut TB and Crohn's

Completed

• Conditions: Crohn Disease; Intestinal Tuberculosis
• Interventions: Diagnostic Test: Magnetic resonance imaging

• Registration Number: NCT03096379
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12-30
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-30
• Primary Completion: 2018-12-30
• Study Completion: 2019-03-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Magnetic resonance imaging	Magnetic resonance imaging	Patients with 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.

Primary Outcome Measures

Name	Time	Method
Small / large bowel transmural enhancement	During procedure	Via magnetic resonance enterography independently interpreted by two radiologist with expertise

Secondary Outcome Measures

Name	Time	Method
Vascular engorgement	During procedure	Via magnetic resonance enterography independently interpreted by two radiologist with expertise
Skip lesions in small / large bowel	During procedure	Via magnetic resonance enterography independently interpreted by two radiologist with expertise
Mesenteric combing	During procedure	Via magnetic resonance enterography independently interpreted by two radiologist with expertise

Trial Locations

Locations (1)

The University of Hong Kong-Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China