MRI Differentiating Gut TB and Crohn's

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096379
• Other study ID #: MRE-TB-CD
• Status: Completed
• Start date: December 30, 2014
• Est. completion date: March 30, 2019

Study information

• Verified date: April 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Intestinal Tuberculosis
• Tuberculosis

Intervention

Diagnostic Test:
• Magnetic resonance imaging
Enterography performed via magnetic resonance imaging

Locations

Country	Name	City	State
China	The University of Hong Kong-Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	The University of Hong Kong-Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small / large bowel transmural enhancement	Via magnetic resonance enterography independently interpreted by two radiologist with expertise	During procedure
Secondary	Skip lesions in small / large bowel	Via magnetic resonance enterography independently interpreted by two radiologist with expertise	During procedure
Secondary	Vascular engorgement	Via magnetic resonance enterography independently interpreted by two radiologist with expertise	During procedure
Secondary	Mesenteric combing	Via magnetic resonance enterography independently interpreted by two radiologist with expertise	During procedure