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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMahidol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ages 18 years or older

Undergoing colonoscopy and found ileal or colonic ulcers

Have ileal and/or colonic tissue sent for mycobacterial tests, including stain for AFB, PCR, and culture

Diagnosed with either intestinal tuberculosis or Crohn's disease a. Criteria of intestinal tuberculosis diagnosis includes any of following: i. Presence of caseating granuloma on pathological examination of specimens ii. Presence of acid-fast bacilli on pathological examination of specimens iii. PCR positive for Mycobacterium tuberculosis iv. Tissue culture growing organisms consistent with Mycobacterium tuberculosis v. Negative results in i to iv but response to empirical treatment with antituberculous therapy All are required to have clinical and endoscopic response to antituberculous therapy (ATT) treatment b. Diagnosis of Crohn's disease is based on clinical, endoscopic, pathological, and/or radiological findings which is confirmed by clinical & endoscopic response to Crohn's disease treatment

Disqualifiers

None

Trial population

All patients who had clinical symptoms suspicious of either Crohn\'s disease or intestinal tuberculosis are eligible.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • interferon gamma releasing assay (IGRA)

    Diagnostic test

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Crohn's disease1 intervention
Group B: Intestinal tuberculosis1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of the ITBvsCD model

The ITBvsCD model performance in differentiating Crohns disease from intestinal tuberculosis will be evaluated by area under the receiver operating characteristic (ROC) curve.

Time frame
with 4 weeks of colonoscopy

Secondary outcomes

Other outcomes

Sponsors and contacts

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Mahidol University

Lead sponsor

Korean Association for the Study of Intestinal Diseases

Collaborator