MRI Differentiating Gut TB and Crohn's
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|ClinicalTrials.gov Identifier: NCT03096379|
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment|
|Crohn Disease Intestinal Tuberculosis||Diagnostic Test: Magnetic resonance imaging|
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.
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Differentiating Gut Tuberculosis and Crohn's Disease Via Magnetic Resonance Enterography|
|Actual Study Start Date :||December 30, 2014|
|Actual Primary Completion Date :||December 30, 2018|
|Actual Study Completion Date :||March 30, 2019|
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.
Diagnostic Test: Magnetic resonance imaging
Enterography performed via magnetic resonance imaging
- Small / large bowel transmural enhancement [ Time Frame: During procedure ]Via magnetic resonance enterography independently interpreted by two radiologist with expertise
- Skip lesions in small / large bowel [ Time Frame: During procedure ]Via magnetic resonance enterography independently interpreted by two radiologist with expertise
- Vascular engorgement [ Time Frame: During procedure ]Via magnetic resonance enterography independently interpreted by two radiologist with expertise
- Mesenteric combing [ Time Frame: During procedure ]Via magnetic resonance enterography independently interpreted by two radiologist with expertise
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096379
|The University of Hong Kong-Shenzhen Hospital|
|Shenzhen, Guangdong, China|
|Principal Investigator:||Wai-Kay Seto, MD||The University of Hong Kong-Shenzhen Hospital|