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

Completed

• Conditions: Intestinal Tuberculosis; Crohn's Disease

• Registration Number: NCT01392365
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-12
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Final diagnosis (Intestinal tuberculosis or Crohn's disease)	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)	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.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of