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RECRUITING
NCT06629194

Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease

Sponsor: Mahidol University

View on ClinicalTrials.gov

Summary

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.

Official title: Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease Utilizing Clinical, Endoscopic, and Interferon-gamma Releasing Assay in Asian Population

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

84

Start Date

2024-06-09

Completion Date

2026-03-01

Last Updated

2024-10-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

interferon gamma releasing assay (IGRA)

All patients who suspected CD or TB will be tested for interferon-gamma releasing assay. An interferon-gamma release assay is a blood test that measures the body\'s immune response to Mycobacterium tuberculosis, the bacteria that causes tuberculosis.

Locations (2)

Assoc. Prof. Julajak Limsrivilai, MD

Bangkok Noi, Bangkok, Thailand

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Thailand