Actively Recruiting

Age: 18Years +
All Genders
NCT06629194

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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