Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease

Study Overview
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Brief Summary
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The aim of this study is to develop a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and Crohn's disease.

Detailed Description
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Crohn's disease and intestinal tuberculosis mimic each other in clinical, endoscopic, and histological features. In addition, the yield of microbiological/histological test (AFB stain, caseating granuloma) is not high in clinical setting. Therefore, distinguishing CD from ITB especially in highly endemic areas for TB is challenging. The aim of this study is to develop and to validate a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and Crohn's disease

Official Title
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Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease

Conditions
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Crohn's Disease, Intestinal Tuberculosis

Participation Criteria
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Eligibility Criteria
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Final diagnostic criteria: Crohn' disease (at least two of the following is met) Clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding Endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease Radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration Macroscopic appearance of bowel-wall induration, mesenteric lymphadenopathy, and creeping fat at laparotomy Pathologic findings of transmural inflammation and/or epithelioid granulomas Intestinal tuberculosis(at least one of the following is met) Histologic evidence of caseating granulomas Histologic demonstration of acid-fast bacilli Growth of M. tuberculosis on tissue culture Clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis with proved tuberculosis elsewhere Response to antituberculous therapy without subsequent recurrence in patients with clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis Exclusion Criteria: Refusal to participate in the study Age: 15 years or younger Comorbidity with acute infectious disease Pregnancy Previous history of medication including anti-TB drugs, immunosuppressive drugs, and chemotherapeutic agents\ Use of antibiotics within the previous three months

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn' disease<br>The group of patients whose final diagnosis is Crohn's disease | |
| Intestinal tuberculosis<br>The group of patients whose final diagnosis is intestinal tuberculosis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final diagnosis (Intestinal tuberculosis or Crohn's disease) | Patients with suspected diagnosis of intestinal tuberculosis or Crohn's disease will be invited to participate in this study. Study variables including past medical history, clinical symptoms and signs, laboratory variables, radiologic findings (Chest X-ray and small bowel follow-through, colonoscopic features) will be gathered at study enrollment. Final diagnosis of intestinal tuberculosis or Crohn's disease will be made according to the diagnostic criteria previously described (Lee YJ, et al. Endoscopy 2006;38:592-597). A prediction model using various variables for intestinal tuberculosis or Crohn's disease will be constructed in the development group and will be validated in the validation group. | 6 months (In a subset of patients, for diagnosis of intestinal tuberculosis, final colonoscopic evaluation after completion of 6-months anti-tuberculous medication is needed) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, Intestinal tuberculosis, Diagnosis, Differential