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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392365
• Other study ID #: 2011-0380
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: June 12, 2016
• Start date: July 2011
• Est. completion date: February 2015

Study information

• Verified date: June 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Final diagnostic criteria:

• Crohn' disease (at least two of the following is met)

1. Clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding

2. Endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease

3. Radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration

4. Macroscopic appearance of bowel-wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy

5. Pathologic findings of transmural inflammation and/or epithelioid granulomas

• Intestinal tuberculosis(at least one of the following is met)

1. Histologic evidence of caseating granulomas

2. Histologic demonstration of acid-fast bacilli

3. Growth of M. tuberculosis on tissue culture

4. Clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis with proved tuberculosis elsewhere

5. 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Intestinal Tuberculosis
• Tuberculosis

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Almadi MA, Ghosh S, Aljebreen AM. Differentiating intestinal tuberculosis from Crohn's disease: a diagnostic challenge. Am J Gastroenterol. 2009 Apr;104(4):1003-12. doi: 10.1038/ajg.2008.162. Epub 2009 Feb 24. Review. — View Citation

Lee YJ, Yang SK, Byeon JS, Myung SJ, Chang HS, Hong SS, Kim KJ, Lee GH, Jung HY, Hong WS, Kim JH, Min YI, Chang SJ, Yu CS. Analysis of colonoscopic findings in the differential diagnosis between intestinal tuberculosis and Crohn's disease. Endoscopy. 2006 — View Citation

Makharia GK, Srivastava S, Das P, Goswami P, Singh U, Tripathi M, Deo V, Aggarwal A, Tiwari RP, Sreenivas V, Gupta SD. Clinical, endoscopic, and histological differentiations between Crohn's disease and intestinal tuberculosis. Am J Gastroenterol. 2010 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No