Actively Recruiting
Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease
Led by Mahidol University · Updated on 2024-10-08
84
Participants Needed
2
Research Sites
90 weeks
Total Duration
On this page
Sponsors
M
Mahidol University
Lead Sponsor
K
Korean Association for the Study of Intestinal Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
Differentiating CD from intestinal tuberculosis (ITB) is difficult due to the low sensitivities of currently available diagnostic tests. The Asia-Pacific guideline recommends anti-tuberculous therapy (ATT) for 8-12 weeks in patients with diagnostic uncertainty due to the risk of disseminated tuberculosis if patients with ITB are misdiagnosed with CD, and are prescribed immunosuppressive therapy. However, treatment with ATT has many side effects and may delay treatment in patients with CD, and this may cause severe relapse and developing complications. Many studies found that some clinical, endoscopy, pathology, radiology, and serology findings can help to improve diagnostic accuracy in these patients. However, no single diagnostic parameter can distinguish between CD and ITB. As a result, many models were developed that include various factors and modalities, and many of those models have been reported to have high performance. However, the number of studies performed to validate those models externally was limited. Correspondingly, this study is designed to prospectively validate models that integrate more advanced parameters (e.g., IGRA, CT enterography findings) with clinical, endoscopic, or pathological findings. However, it aims mainly to evaluate the model integrating clinical, endoscopic, and serological variables since CT enterography and pathological interpretation require experienced radiologists and pathologists but they are not available in many centers.
CONDITIONS
Official Title
Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Undergoing colonoscopy with ileal or colonic ulcers found
- Have ileal and/or colonic tissue tested for mycobacterial infections including stain for acid-fast bacilli, PCR, and culture
- Diagnosed with either intestinal tuberculosis or Crohn's disease based on clinical, endoscopic, pathological, and/or radiological findings and response to treatment
You will not qualify if you...
- Patients with ileal or colonic ulcers caused by diseases other than intestinal tuberculosis or Crohn's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Assoc. Prof. Julajak Limsrivilai, MD
Bangkok Noi, Bangkok, Thailand, 10700
Actively Recruiting
2
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Not Yet Recruiting
Research Team
J
Julajak Limsrivilai
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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