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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Byong Duk Ye, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01392365
First received: July 11, 2011
Last updated: November 8, 2013
Last verified: November 2013

July 11, 2011
November 8, 2013
July 2011
July 2014   (final data collection date for primary outcome measure)
Final diagnosis(Crohn's disease or Intestinal tuberculosis) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

At 2 months after the first visit, we will analyze the results of laboratory, endoscopic, radiologic, microbiologic/histological tests.

  • History (age, gender, symptoms)
  • CBC, CRP, ESR
  • ASCA antibody (IgA, IgG)
  • QuantiFERON-TB Gold
  • Colonoscopic finding
  • Histological finding(including Acid Fast Bacilli stain/Culture)
Same as current
Complete list of historical versions of study NCT01392365 on ClinicalTrials.gov Archive Site
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Development of a Score for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease
Development of a Score for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease

The aim of this study is to develop a score for differential diagnosis between intestinal tuberculosis and Crohn's disease.

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 a score for differential diagnosis between intestinal tuberculosis and Crohn's disease

Observational
Time Perspective: Prospective
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Probability Sample

Patients who have common features of crohn's disease and intestinal tuberculosis

  • Crohn's Disease
  • Intestinal Tuberculosis
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  • Crohn' disease
    The group of patients whose final diagnosis is Crohn's disease
  • Intestinal tuberculosis
    The group of patients whose final diagnosis is intestinal tuberculosis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • tentative diagnosis of 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
  • tentative diagnosis of 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:

  • Age younger than 16
  • Pregnancy
  • Combined with acute infectious diseases
Both
16 Years and older
No
Contact: Byong Duk Ye, M.D. 82-2-3010-3181 bdyemd@gmail.com
Contact: Sang Hyoung Park, M.D. 82-2-3010-5768 umdalpin@hanmail.net
Korea, Republic of
 
NCT01392365
2011-0380
No
Byong Duk Ye, Asan Medical Center
Asan Medical Center
Not Provided
Not Provided
Asan Medical Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP