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

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.

NCT Number	NCT06629194
Lead Sponsor	Mahidol University Collaborators: Korean Association for the Study of Intestinal Diseases
Conditions	Crohn Disease, Intestinal Tuberculosis, Differential Diagnosis
Enrollment	84 participants
Start Date	2024-06-09
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-03-01 (estimated)
Updated on ClinicalTrials.gov	2024-10-08