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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
Sponsor:
Collaborator:
The University of Hong Kong-Shenzhen Hospital
Information provided by (Responsible Party):
Wai-Kay Seto, 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.

Condition or disease Intervention/treatment
Crohn Disease Intestinal Tuberculosis Diagnostic Test: Magnetic resonance imaging

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.


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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Small / large bowel transmural enhancement [ Time Frame: During procedure ]
    Via magnetic resonance enterography independently interpreted by two radiologist with expertise


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive 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.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China, Guangdong
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China
Sponsors and Collaborators
The University of Hong Kong
The University of Hong Kong-Shenzhen Hospital
Investigators
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Principal Investigator: Wai-Kay Seto, MD The University of Hong Kong-Shenzhen Hospital

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Responsible Party: Wai-Kay Seto, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03096379     History of Changes
Other Study ID Numbers: MRE-TB-CD
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wai-Kay Seto, The University of Hong Kong:
TB
CD
MRE
ileocecal
Additional relevant MeSH terms:
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Tuberculosis
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections