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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Byong Duk Ye, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01392365
First received: July 11, 2011
Last updated: June 12, 2016
Last verified: June 2016

July 11, 2011
June 12, 2016
July 2011
February 2015   (final data collection date for primary outcome measure)
Final diagnosis (Intestinal tuberculosis or Crohn's disease) [ Time Frame: 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) ] [ Designated as safety issue: No ]
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.
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)
Complete list of historical versions of study NCT01392365 on ClinicalTrials.gov Archive Site
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Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease
Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease
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.
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
Observational
Time Perspective: Prospective
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Non-Probability Sample
Patients suspected to have intestinal tuberculosis or Crohn's disease based on clinical history, symptoms, and/or colonoscopic findings are invited to participate in this study.
  • 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.
 
Completed
117
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01392365
2011-0380
No
No
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Byong Duk Ye, Asan Medical Center
Asan Medical Center
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Asan Medical Center
June 2016

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