MRI Differentiating Gut TB and Crohn's

NCT03096379 | Completed

• 1 other identifier: MRE-TB-CD
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Intestinal Tuberculosis

Keywords

TB; CD; MRE; ileocecal

Outcome Measures

Primary Outcomes (1)

• Small / large bowel transmural enhancement

  Via magnetic resonance enterography independently interpreted by two radiologist with expertise

  During procedure

Secondary Outcomes (3)

• Skip lesions in small / large bowel

  During procedure

• Vascular engorgement

  During procedure

• Mesenteric combing

  During procedure

Study Arms (1)

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

Interventions

Magnetic resonance imaging DIAGNOSTIC_TEST

Enterography performed via magnetic resonance imaging

Magnetic resonance imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The University of Hong Kong-Shenzhen Hospital: collaborator

Study Sites (1)

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wai-Kay Seto, MD

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 30, 2017
• Study Start: December 30, 2014
• Primary Completion: December 30, 2018
• Study Completion: March 30, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)