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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
NOT_YET_RECRUITING
Bangkok
Assoc. Prof. Julajak Limsrivilai, MD
RECRUITING
Bangkok Noi
Contact Information
Primary
Julajak Limsrivilai
alimsrivilai@gmail.com
+66814968895
Time Frame
Start Date: 2024-06-09
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 84
Treatments
Crohn's disease
Patients who were diagnosed Crohn's disease~\- 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
Intestinal tuberculosis
Patients who were diagnosed intestinal tuberculosis.~* 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
Sponsors
Collaborators: Korean Association for the Study of Intestinal Diseases
Leads: Mahidol University

This content was sourced from clinicaltrials.gov

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