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

NCT06629194 | Recruiting

• 1 other identifier: Si212/2024
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Crohn Disease; Intestinal Tuberculosis; Differential Diagnosis

Keywords

Intestinal tuberculosis; Crohn Disease

Outcome Measures

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.

  with 4 weeks of colonoscopy

Study Arms (2)

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

Diagnostic Test: interferon gamma releasing assay (IGRA)

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

Diagnostic Test: interferon gamma releasing assay (IGRA)

Interventions

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.

Crohn's disease; Intestinal tuberculosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \. Patients with ileal/colonic ulcers caused by other diseases

Sponsors & Collaborators

• Mahidol University: lead
• Korean Association for the Study of Intestinal Diseases: collaborator

Study Sites (2)

Assoc. Prof. Julajak Limsrivilai, MD

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

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

Bangkok, 10700, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Julajak Limsrivilai

  Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julajak Limsrivilai

CONTACT

+66814968895; alimsrivilai@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: October 8, 2024
• Study Start: June 9, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)